Renewal of Provisional Consent to the Distribution of Medicines
Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Product: | Clopine |
Active Ingredient: | Clozapine 25mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
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Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clopine |
Active Ingredient: | Clozapine 50mg/mL |
Dosage Form: | Oral suspension |
New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
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Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clopine |
Active Ingredient: | Clozapine 50mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
|
Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clopine |
Active Ingredient: | Clozapine 100mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
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Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clopine |
Active Ingredient: | Clozapine 200mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
Manufacturer: | Douglas Manufacturing Limited, Auckland, New Zealand |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
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Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clozaril |
Active Ingredient: | Clozapine 25mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Mylan New Zealand Limited |
Manufacturers: | Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Ireland |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
|
Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | Clozaril |
Active Ingredient: | Clozapine 100mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Mylan New Zealand Limited |
Manufacturers: | Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Ireland |
Note: This consent is given subject to the following conditions: 1. The medicine may only be prescribed by:
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines. 3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines. 4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place. |
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Note: This renewed consent is valid for two years from 10 July 2020. | |
Product: | PiperTaz Sandoz |
Active Ingredients: | Piperacillin monohydrate 4.198g equivalent to piperacillin sodium 4.2531g equivalent to piperacillin 4.0g Tazobactam 0.5g equivalent to tazobactam sodium 0.54733g |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Sandoz GmbH, Kundl, Austria |
Note: This consent is given subject to the following conditions:
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Note: This renewed consent is valid for one year from 6 August 2020. |
Dated this 6th day of July 2020.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).