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: | Biomed Fentanyl |
| Active Ingredient: | Fentanyl citrate 15.71mg/L equivalent to fentanyl 10mg/L |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Note: This renewed consent is valid for two years from 23 September 2021. | |
| Product: | Biomed Fentanyl |
| Active Ingredient: | Fentanyl citrate 31.42mg/L equivalent to fentanyl 20mg/L |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Note: This renewed consent is valid for two years from 23 September 2021. | |
| Product: | Daunorubicin |
| Active Ingredient: | Daunorubicin hydrochloride 2.14mg/mL equivalent to daunorubicin 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer (Perth) Pty Limited, Perth, Australia |
| Note: This renewed consent is valid for two years from 26 September 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 2.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 7.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 15mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 20mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
| Product: | Lenalidomide Te Arai |
| Active Ingredient: | Lenalidomide 25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Note: This consent is given subject to the following conditions: 1. Lenalidomide Te Arai may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. 2. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai. |
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| Note: This renewed consent is valid for two years from 24 October 2021. | |
Dated this 10th day of September 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).