{"RequestedPageEnd":20,"RequestedPageStart":1,"Results":[{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9978","Manufacturers":[],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4 mg\/2 mL injection ampoule","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2013-PI-01055-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Injection, solution","RouteOfAdministration":"Intravenous","VisualIdentification":"Clear colourless liquid, practically free of particles."}],"Containers":[{"Closure":"","Conditions":["Protect from Light"],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Ampoule"}],"EffectiveDate":"2022-06-02","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ondansetron hydrochloride dihydrate ","Strength":"5.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"citric acid monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium citrate dihydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium chloride ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"water for injections ","Strength":""}],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4 mg\/2 mL injection ampoule","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 ampoule pack"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"2 mL x 4"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"2mL x 1 (plastic)"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"2mL x 2 (plastic)"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"2mL x 5 (glass and plastic)"}],"SpecificIndications":["Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy Ondersertron (injection) is also indicated for the prevention and treatment of post-operative nausea and vomiting."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"34-36 Chandos Street","AddressLine2":"","Country":"Australia","Postcode":"2065","State":"NSW","Suburb":"ST LEONARDS"},"Name":"Aspen Pharmacare Australia Pty Ltd"},"StartDate":"1991-04-17","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["The conditions applying to these goods when they are exported from Australia are given below:","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:"],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2014-CMI-02956-1"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9979","Manufacturers":[],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4mg tablet blister pack","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2013-PI-01055-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, film coated","RouteOfAdministration":"Oral","VisualIdentification":"Yellow, oval, bi-convex tablets, engraved with \"GXET3\" on one face and plain on the other face."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Blister Pack"}],"EffectiveDate":"2022-06-24","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ondansetron hydrochloride dihydrate ","Strength":"5.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"microcrystalline cellulose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"pregelatinised maize starch ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"titanium dioxide ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"iron oxide yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"hypromellose ","Strength":""}],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4mg tablet blister pack","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 tablets, 10 tablets foil blister pack"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"15 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"4 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"90 tablets"}],"SpecificIndications":["Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy"],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"34-36 Chandos Street","AddressLine2":"","Country":"Australia","Postcode":"2065","State":"NSW","Suburb":"ST LEONARDS"},"Name":"Aspen Pharmacare Australia Pty Ltd"},"StartDate":"1991-04-17","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","The conditions applying to these goods when they are exported from Australia are given below:","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:"],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9980","Manufacturers":[],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4mg tablet bottle","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2013-PI-01055-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, film coated","RouteOfAdministration":"Oral","VisualIdentification":"Yellow, oval, bi-convex tablets, engraved with \"GXET3\" on one face and plain on the other face."}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Bottle"}],"EffectiveDate":"2022-06-02","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ondansetron hydrochloride dihydrate ","Strength":"5.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"microcrystalline cellulose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"pregelatinised maize starch ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"titanium dioxide ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"iron oxide yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"hypromellose ","Strength":""}],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 4mg tablet bottle","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"100 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"15  tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30  tablets"}],"SpecificIndications":["Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy"],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"34-36 Chandos Street","AddressLine2":"","Country":"Australia","Postcode":"2065","State":"NSW","Suburb":"ST LEONARDS"},"Name":"Aspen Pharmacare Australia Pty Ltd"},"StartDate":"1991-04-17","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","The conditions applying to these goods when they are exported from Australia are given below:"],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2014-CMI-02956-1"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9981","Manufacturers":[],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 8mg tablet blister pack","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2013-PI-01055-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, film coated","RouteOfAdministration":"Oral","VisualIdentification":"Yellow, oval, bi-convex tablets, engraved with \"GXET5\" on one face and plain on the other face."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Blister Pack"}],"EffectiveDate":"2022-06-24","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ondansetron hydrochloride dihydrate ","Strength":"10.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"microcrystalline cellulose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"pregelatinised maize starch ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"titanium dioxide ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"iron oxide yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"hypromellose ","Strength":""}],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 8mg tablet blister pack","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 tablets, 10 tablets foil blister pack"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"15 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"4 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"90 tablets"}],"SpecificIndications":["Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy"],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"34-36 Chandos Street","AddressLine2":"","Country":"Australia","Postcode":"2065","State":"NSW","Suburb":"ST LEONARDS"},"Name":"Aspen Pharmacare Australia Pty Ltd"},"StartDate":"1991-04-17","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","The conditions applying to these goods when they are exported from Australia are given below:","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:"],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9982","Manufacturers":[],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 8mg tablet bottle","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2013-PI-01055-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, film coated","RouteOfAdministration":"Oral","VisualIdentification":"Yellow, oval, bi-convex tablets, engraved with \"GXET5\" on one face and plain on the other face."}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Bottle"}],"EffectiveDate":"2022-06-02","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ondansetron hydrochloride dihydrate ","Strength":"10.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"microcrystalline cellulose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"pregelatinised maize starch ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"titanium dioxide ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"iron oxide yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"hypromellose ","Strength":""}],"Name":"ZOFRAN ondansetron (as hydrochloride dihydrate) 8mg tablet bottle","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"100 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"15 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30 tablets"}],"SpecificIndications":["Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy"],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"34-36 Chandos Street","AddressLine2":"","Country":"Australia","Postcode":"2065","State":"NSW","Suburb":"ST LEONARDS"},"Name":"Aspen Pharmacare Australia Pty Ltd"},"StartDate":"1991-04-17","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-05403-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9983","Manufacturers":[],"Name":"PROSTIN E2 VAGINAL GEL 1mg (Dinoprostone)","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-05404-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Gel","RouteOfAdministration":"Vaginal","VisualIdentification":"Homogenous, colourless, semi-translucent viscous gel."}],"Containers":[{"Closure":"","Conditions":["Do not Freeze"],"LifeTime":"2 Years","Material":null,"Temperature":"Store at 2 to 8 degrees Celsius","Type":"Syringe"}],"EffectiveDate":"2024-10-08","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"dinoprostone ","Strength":"0.3333 mg\/g"},{"EquivDetail":"","FormulationType":"Excipient","Name":"colloidal anhydrous silica ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"triacetin ","Strength":""}],"Name":"PROSTIN E2 VAGINAL GEL 1mg","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"3g (wt) or 2.5mL (vol)"}],"SpecificIndications":["For induction of labour in term or near-term pregnant women who have favourable induction features. INDICATIONS AS AT 27 AUGUST 2003: Induction of labour in term or near-term pregnant women who have favourable induction features; and who have singleton pregnancy with a vertex presentation."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"GPO Box 7015","AddressLine2":"","Country":"Australia","Postcode":"2001","State":"NSW","Suburb":"Sydney"},"Name":"Pfizer Australia Pty Ltd"},"StartDate":"1991-08-27","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-05403-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9984","Manufacturers":[],"Name":"PROSTIN E2 VAGINAL GEL 2mg (Dinoprostone)","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-05404-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Gel","RouteOfAdministration":"Vaginal","VisualIdentification":"Homogenous, colourless, semi-translucent viscous gel."}],"Containers":[{"Closure":"","Conditions":["Do not Freeze"],"LifeTime":"2 Years","Material":null,"Temperature":"Store at 2 to 8 degrees Celsius","Type":"Syringe"}],"EffectiveDate":"2024-10-08","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Excipient","Name":"colloidal anhydrous silica ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"dinoprostone ","Strength":"0.6667 mg\/g"},{"EquivDetail":"","FormulationType":"Excipient","Name":"triacetin ","Strength":""}],"Name":"PROSTIN E2 VAGINAL GEL 2mg","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"3g (wt) or 2.5mL (vol)"}],"SpecificIndications":["For induction of labour in term or near-term pregnant women who have favourable induction features. INDICATIONS AS AT 27 AUGUST 2003: Induction of labour in term or near-term pregnant women who have favourable induction features; and who have singleton pregnancy with a vertex presentation."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"GPO Box 7015","AddressLine2":"","Country":"Australia","Postcode":"2001","State":"NSW","Suburb":"Sydney"},"Name":"Pfizer Australia Pty Ltd"},"StartDate":"1991-08-27","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2015-CMI-01389-1"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"9987","Manufacturers":[],"Name":"AURORIX moclobemide 150mg tablet blister pack","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2014-PI-02637-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, film coated","RouteOfAdministration":"Oral","VisualIdentification":"Oval, cylindrical, biconvex, pale yellow tablet marked \"150\" on one side with a break bar on the other side."}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"5 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Blister Pack"}],"EffectiveDate":"2023-07-11","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Excipient","Name":"Aquacoat ECD Ethylcellulose Aqueous Dispersion NF ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"povidone ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"purified talc ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"titanium dioxide ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium starch glycollate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"hypromellose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"iron oxide yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"moclobemide ","Strength":"150.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"macrogol 6000 ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"maize starch ","Strength":""}],"Name":"AURORIX 150mg tablet blister pack","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 tablets (sample pack)"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"60 tablets"}],"SpecificIndications":["Treatment of major depression."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"Level 1 30 The Bond","AddressLine2":"30-34 Hickson Road","Country":"Australia","Postcode":"2000","State":"NSW","Suburb":"Millers Point"},"Name":"Viatris Pty Ltd"},"StartDate":"1991-08-02","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 15 February 1991.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 15 February 1991."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2016-CMI-01173-1"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10013","Manufacturers":[],"Name":"TECHNESCAN MAG3 Kit for preparation of Technetium (99mTc) mertiatide powder for injection multidose vial","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2016-PI-01172-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Injection, powder for","RouteOfAdministration":"Intravenous","VisualIdentification":"Powder lyophilized"}],"Containers":[{"Closure":"Child resistant closure","Conditions":["Protect from Light"],"LifeTime":"12 Months","Material":null,"Temperature":"Store between 15-25 degrees Celsius","Type":"Vial"}],"EffectiveDate":"2026-08-31","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"betiatide ","Strength":"1.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"stannous chloride dihydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium tartrate dihydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""}],"Name":"TECHNESCAN MAG3 Powder for injection","Packs":[{"PoisonSchedule":"Not scheduled. Not considered by committee","Size":"5 vials of powder in 10mL"}],"SpecificIndications":["For use in the preparation of Technetium TC99m mertiatide for use as a renal imaging agent and for estimating split renal function. INDICATIONS AS AT 19 JULY 2001: Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"Locked Bag 7002","AddressLine2":"","Country":"Australia","Postcode":"2124","State":"NSW","Suburb":"Parramatta"},"Name":"Landauer Radiopharmaceuticals Pty Ltd"},"StartDate":"1991-06-12","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 15 February 1991.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 15 February 1991."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-01614-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10018","Manufacturers":[],"Name":"CERETEC kit for preparation of technetium (99mTc) exametazime powder for injection vial","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2009-PI-00874-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Injection, powder for","RouteOfAdministration":"Intravenous","VisualIdentification":"White freeze-dried powder"}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"52 Weeks","Material":null,"Temperature":"Store between 2 - 25 degrees celsius","Type":"Vial"}],"EffectiveDate":"2026-07-23","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"exametazime ","Strength":"0.5000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium chloride ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"stannous chloride dihydrate ","Strength":""}],"Name":"CERETEC kit for preparation of technetium (99mTc) exametazime powder for injection vial","Packs":[{"PoisonSchedule":"Not scheduled. Not considered by committee","Size":"5mg x 2"},{"PoisonSchedule":"Not scheduled. Not considered by committee","Size":"5mg x 5"}],"SpecificIndications":["For use in the preparation of Technetium Tc 99m exametazime for intravenous administration in specialised units for scintigraphic localisation of seizure foci in patients with temporal lobe epilepsy."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"241 O'Riordan Street","AddressLine2":"","Country":"Australia","Postcode":"2020","State":"NSW","Suburb":"Mascot"},"Name":"GE Healthcare Australia Pty Ltd"},"StartDate":"1991-09-23","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\""],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2019-CMI-01803-1"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10047","Manufacturers":[],"Name":"CYMEVENE ganciclovir 500mg (as sodium) powder for injection vial","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2019-PI-01802-1"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Injection, powder for","RouteOfAdministration":"Intravenous","VisualIdentification":"White to off-white lyophilised powder"}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Vial"}],"EffectiveDate":"2025-01-10","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"ganciclovir sodium ","Strength":"543.0000 mg"}],"Name":"CYMEVENE 500mg (as sodium) powder for injection vial","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"5 x 500mg vials"}],"SpecificIndications":["INDICATIONS AS AT 12 October 2005: CYMEVENE (ganciclovir) administered as the intravenous infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease. NOTE: CYMEVENE (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"Level 9 Tower A Zenith Towers 821 Pacific Highway Chatswood","AddressLine2":"","Country":"Australia","Postcode":"2067","State":"NSW","Suburb":"Sydney"},"Name":"Pharmaco Australia Ltd"},"StartDate":"1991-06-11","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-05584-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10052","Manufacturers":[],"Name":"NORIDAY 28 DAY norethisterone 350 microgram tablet blister pack","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-05583-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Tablet, uncoated","RouteOfAdministration":"Oral","VisualIdentification":"White, flat, round tablet with bevelled edges approximately, 7\/32 inch diameter inscribed \"Searle\" on one side and \"NY\" on the other."}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"5 Years","Material":null,"Temperature":"Store below 25 degrees Celsius","Type":"Blister Pack"}],"EffectiveDate":"2025-06-23","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"norethisterone ","Strength":"350.0000 microgram"},{"EquivDetail":"","FormulationType":"Excipient","Name":"magnesium stearate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"povidone ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"lactose monohydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"maize starch ","Strength":""}],"Name":"NORIDAY 28 DAY norethisterone 350 microgram tablet blister pack","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"1 x 28 tablets"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"4 x 28 tablets (112 tablets)"}],"SpecificIndications":["INDICATIONS AS AT 9 MARCH 2003 : NORIDAY is an oral contraceptive for women who will not, or cannot tolerate other oral contraceptives or intrauterine devices."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"GPO Box 7015","AddressLine2":"","Country":"Australia","Postcode":"2001","State":"NSW","Suburb":"Sydney"},"Name":"Pfizer Australia Pty Ltd"},"StartDate":"1991-06-11","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-04677-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10063","Manufacturers":[],"Name":"PULMICORT TURBUHALER budesonide 100 microgram\/ actuation insufflation dry powder inhaler","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-04678-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Insufflation","RouteOfAdministration":"Inhalation","VisualIdentification":"CONTAINER Plastic container, light-brown turning grip 'BUDESONIDE 100' embossed base. PRODUCT White to off-white rounded granules which disintegrate to fine powder upon slight pressure.\""}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":["Replace the cover firmly after use"],"LifeTime":"2 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Inhaler - dry powder"}],"EffectiveDate":"2026-03-27","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"budesonide ","Strength":"100.0000 microgram\/actuation"}],"Name":"PULMICORT Turbuhaler 100 microgram\/dose","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"single plastic container, 200 dose"}],"SpecificIndications":["Treatment of bronchial asthma. INDICATIONS AS AT 3 June 1994: Treatment of bronchial asthma. May also be used when replacement or reduction in oral steroid therapy is desired."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 131","AddressLine2":"","Country":"Australia","Postcode":"1670","State":"NSW","Suburb":"NORTH RYDE"},"Name":"AstraZeneca Pty Ltd"},"StartDate":"1991-07-31","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-04677-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10064","Manufacturers":[],"Name":"PULMICORT TURBUHALER budesonide 400 microgram\/ actuation insufflation dry powder inhaler","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-04678-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Insufflation","RouteOfAdministration":"Inhalation","VisualIdentification":"CONTAINER - Plastic container dark-brown turning base embossed 'BUDESONIDE 400'on bottom. PRODUCT- White to off-white rounded granules which disintegrate to a fine powder upon slight pressure."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":["Replace the cover firmly after use"],"LifeTime":"2 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Inhaler - dry powder"}],"EffectiveDate":"2026-03-27","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"budesonide ","Strength":"400.0000 microgram\/actuation"}],"Name":"PULMICORT TURBUHALER 400 microgram\/dose","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"50 doses"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"single plastic container, 200 dose"}],"SpecificIndications":["Treatment of bronchial asthma. INDICATIONS AS AT 3 June 1994: Treatment of bronchial asthma. May also be used when replacement or reduction in oral steroid therapy is desired."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 131","AddressLine2":"","Country":"Australia","Postcode":"1670","State":"NSW","Suburb":"NORTH RYDE"},"Name":"AstraZeneca Pty Ltd"},"StartDate":"1991-07-31","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-04677-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10065","Manufacturers":[],"Name":"PULMICORT TURBUHALER budesonide 200 microgram\/ actuation insufflation dry powder inhaler","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-04678-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Insufflation","RouteOfAdministration":"Inhalation","VisualIdentification":"Container - Plastic container mid-brown turning base embossed 'BUDESONIDE 200'. Product - White to off-white rounded granules which disintegrate to a fine powder upon slight pressure."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":["Replace the cover firmly after use"],"LifeTime":"2 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Inhaler - dry powder"}],"EffectiveDate":"2026-03-27","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"budesonide ","Strength":"200.0000 microgram\/actuation"}],"Name":"PULMICORT TURBUHALER 200 microgram\/dose","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"single plastic container, 200 dose"}],"SpecificIndications":["Treatment of bronchial asthma. INDICATIONS AS AT 3 June 1994: Treatment of bronchial asthma. May also be used when replacement or reduction in oral steroid therapy is desired."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 131","AddressLine2":"","Country":"Australia","Postcode":"1670","State":"NSW","Suburb":"NORTH RYDE"},"Name":"AstraZeneca Pty Ltd"},"StartDate":"1991-07-31","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","The conditions applying to these goods when they are exported from Australia are given below:","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:","This product must not be supplied for sale in Australia, including supply via duty free outlets.","The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i) each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-04677-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10071","Manufacturers":[],"Name":"PULMICORT RESPULES budesonide 0.5mg\/mL inhalation ampoule","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-04678-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Inhalation, conventional","RouteOfAdministration":"Inhalation","VisualIdentification":"An easily resuspendable white to off-white suspension."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":["Do not Freeze","Do not Refrigerate"],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Ampoule"}],"EffectiveDate":"2026-01-22","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"budesonide ","Strength":"0.5000 mg\/mL"},{"EquivDetail":"","FormulationType":"Excipient","Name":"disodium edetate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium chloride ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"polysorbate 80 ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"citric acid ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium citrate dihydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"water for injections ","Strength":""}],"Name":"PULMICORT RESPULES budesonide 0.5mg\/mL inhalation ampoule","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"20 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"40 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"5 x 2mL"}],"SpecificIndications":["Treatment of bronchial asthma and long term prophylaxis. INDICATIONS AS APPROVED 15 JULY 1997: Treatment of bronchial asthma. Pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. Treatment of acute laryngotracheobronchitis (croup) in infants and children."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 131","AddressLine2":"","Country":"Australia","Postcode":"1670","State":"NSW","Suburb":"NORTH RYDE"},"Name":"AstraZeneca Pty Ltd"},"StartDate":"1991-07-31","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Drug Safety Evaluation Branch","BlackTriangleSchemeFlag":"N","Conditions":["Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No. 8 and condition No. 9.","The conditions applying to these goods when they are exported from Australia are given below:","Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995, other than condition No.11","The therapeutic goods grouped in this registration\/listing as export only goods under the following names are included in the Australian Register of Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:","The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i) each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.","This product must not be supplied for sale in Australia, including supply via duty free outlets."],"ConsumerInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-CMI-04677-3"},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10072","Manufacturers":[],"Name":"PULMICORT RESPULES budesonide 0.25mg\/mL inhalation ampoule","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":"https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2010-PI-04678-3"},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Inhalation, conventional","RouteOfAdministration":"Inhalation","VisualIdentification":"An easily resuspendable white to off-white suspension."}],"Containers":[{"Closure":"Neither child resistant closure nor restricted flow insert","Conditions":["Do not Freeze","Do not Refrigerate"],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Ampoule"}],"EffectiveDate":"2026-01-22","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Active","Name":"budesonide ","Strength":"0.2500 mg\/mL"},{"EquivDetail":"","FormulationType":"Excipient","Name":"disodium edetate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium chloride ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"polysorbate 80 ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"citric acid ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium citrate dihydrate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"water for injections ","Strength":""}],"Name":"PULMICORT RESPULES budesonide 0.25mg\/mL inhalation ampoule","Packs":[{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"10 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"20 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"30 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"40 x 2mL"},{"PoisonSchedule":"(S4) Prescription Only Medicine","Size":"5 x 2mL"}],"SpecificIndications":["Treatment of bronchial asthma.   INDICATIONS AS APPROVED 15 JULY 1997: Treatment of bronchial asthma.   Pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. Treatment of acute laryngotracheobronchitis (croup) in infants and children."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 131","AddressLine2":"","Country":"Australia","Postcode":"1670","State":"NSW","Suburb":"NORTH RYDE"},"Name":"AstraZeneca Pty Ltd"},"StartDate":"1991-07-31","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Listed Medicines","BlackTriangleSchemeFlag":"","Conditions":["The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.","The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.","The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.","All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified of the report or reports.","The sponsor shall not supply the listed medicine after the expiry date of the goods.","Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor."],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Listed","LicenceClass":"","LicenceId":"10079","Manufacturers":[],"Name":"GOANNA TEA TREE OIL ANTISEPTIC lotion","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":""},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Lotion","RouteOfAdministration":"Topical","VisualIdentification":""}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":" ","Material":null,"Temperature":"","Type":""}],"EffectiveDate":"2019-09-01","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Excipient","Name":"isopropyl alcohol ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"purified water ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"Melaleuca Oil ","Strength":"150.0000 mg\/g"},{"EquivDetail":"","FormulationType":"Excipient","Name":"polysorbate 20 ","Strength":""}],"Name":"GOANNA TEA TREE OIL ANTISEPTIC lotion","Packs":[{"PoisonSchedule":"","Size":""}],"SpecificIndications":[""],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"Suite 2 Level 2 19-23 Prospect Street","AddressLine2":"","Country":"Australia","Postcode":"3128","State":"VIC","Suburb":"Box Hill"},"Name":"Lupin Australia Pty Limited"},"StartDate":"1991-08-13","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Non-Prescription Medicines","BlackTriangleSchemeFlag":"","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10096","Manufacturers":[],"Name":"CEPACAINE ORAL SOLUTION mouthwash bottle","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":""},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Mouthwash","RouteOfAdministration":"Oral","VisualIdentification":"Clear, green aqueous\/alcoholic solution"}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Bottle"}],"EffectiveDate":"2025-10-08","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Excipient","Name":"benzyl alcohol ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"benzocaine ","Strength":"4.0000 mg\/mL"},{"EquivDetail":"","FormulationType":"Excipient","Name":"Peppermint Oil ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"glycerol ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sunset yellow FCF ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"brilliant blue FCF ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"methyl salicylate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"disodium edetate ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"cineole ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"menthol ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sodium chloride ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"purified water ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"ethanol ","Strength":"15.0000 % v\/v"},{"EquivDetail":"","FormulationType":"Excipient","Name":"poloxamer ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"quinoline yellow ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"cetylpyridinium chloride ","Strength":"500.0000 microgram\/mL"}],"Name":"CEPACAINE ORAL SOLUTION mouthwash bottle","Packs":[{"PoisonSchedule":"(S2) Pharmacy Medicine","Size":"200mL"}],"SpecificIndications":["For temporary relief of the pain associated with minor infections. Cepacaine is also indicated for the discomfort following dental procedures and minor surgery of the mouth."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 5033","AddressLine2":"","Country":"Australia","Postcode":"1515","State":"NSW","Suburb":"WEST CHATSWOOD"},"Name":"iNova Pharmaceuticals (Australia) Pty Ltd"},"StartDate":"1991-07-08","Status":"Active"},{"AnnualChargeExemptWaverDate":null,"AnnualChargeExemptWaverFlag":"","ApprovalArea":"Non-Prescription Medicines","BlackTriangleSchemeFlag":"","Conditions":["Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Conditions Applying to Therapeutic Goods Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989\"","Conditions applicable to all therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995.","Conditions applicable to the relevant category and class of therapeutic goods as specified in the document \"Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989\" effective 1 July 1995."],"ConsumerInformation":{"DocumentLink":""},"DeviceProductNames":[],"EntryType":"Medicine Registered","LicenceClass":"","LicenceId":"10097","Manufacturers":[],"Name":"CEPACOL PLUS WITH ANAESTHETIC original flavour lozenge blister pack","NilTurnoverDate":null,"NilTurnoverFlag":"","ProductCategory":"Medicine","ProductInformation":{"DocumentLink":""},"Products":[{"AdditionalInformation":[],"Components":[{"DosageForm":"Lozenge","RouteOfAdministration":"Oral","VisualIdentification":"Hard green round lozenge with a slight concave surface"}],"Containers":[{"Closure":"","Conditions":[""],"LifeTime":"3 Years","Material":null,"Temperature":"Store below 30 degrees Celsius","Type":"Blister Pack"}],"EffectiveDate":"2010-09-06","GMDNCode":"","GMDNTerm":"","Ingredients":[{"EquivDetail":"","FormulationType":"Excipient","Name":"brilliant blue FCF ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sunset yellow FCF ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"sucrose ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"liquid glucose ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"benzocaine ","Strength":"10.0000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"purified water ","Strength":""},{"EquivDetail":"","FormulationType":"Active","Name":"cetylpyridinium chloride ","Strength":"1.3000 mg"},{"EquivDetail":"","FormulationType":"Excipient","Name":"Lime Oil Distilled ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"Lemon Oil ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"macrogol 400 ","Strength":""},{"EquivDetail":"","FormulationType":"Excipient","Name":"quinoline yellow ","Strength":""}],"Name":"CEPACOL PLUS WITH ANAESTHETIC original flavour lozenge blister pack","Packs":[{"PoisonSchedule":"(S2) Pharmacy Medicine","Size":"16 lozenges"}],"SpecificIndications":["Anaesthetic\/antibacterial lozenges for symptomatic relief from the pain and discomfort of sore throats, minor mouth infections and pain caused by oral surgery or dental procedures (on dental advice)."],"StandardIndications":[],"Type":"Single Medicine Product","Warnings":[]}],"Sponsor":{"Address":{"AddressLine1":"PO Box 5033","AddressLine2":"","Country":"Australia","Postcode":"1515","State":"NSW","Suburb":"WEST CHATSWOOD"},"Name":"iNova Pharmaceuticals (Australia) Pty Ltd"},"StartDate":"1991-07-08","Status":"Active"}],"TotalRecords":97075}