Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
| Product: |
Pomolide |
| Active Ingredient: |
Pomalidomide 1mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Juno Pharmaceuticals NZ Limited |
| Manufacturer: |
Natco Pharma Limited, Telangana, India |
|
Note: This consent is given subject to the following conditions:
- Pomolide 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.
- Juno Pharmaceutical NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This consent is valid for two years from the date of publication of this notice.
|
| Product: |
Pomolide |
| Active Ingredient: |
Pomalidomide 2mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Juno Pharmaceuticals NZ Limited |
| Manufacturer: |
Natco Pharma Limited, Telangana, India |
|
Note: This consent is given subject to the following conditions:
- Pomolide 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.
- Juno Pharmaceutical NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This consent is valid for two years from the date of publication of this notice. |
| Product: |
Pomolide |
| Active Ingredient: |
Pomalidomide 3mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Juno Pharmaceuticals NZ Limited |
| Manufacturer: |
Natco Pharma Limited, Telangana, India |
|
Note: This consent is given subject to the following conditions:
- Pomolide 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.
- Juno Pharmaceutical NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This consent is valid for two years from the date of publication of this notice. |
| Product: |
Pomolide |
| Active Ingredient: |
Pomalidomide 4mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Juno Pharmaceuticals NZ Limited |
| Manufacturer: |
Natco Pharma Limited, Telangana, India |
|
Note: This consent is given subject to the following conditions:
- Pomolide 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.
- Juno Pharmaceutical NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This consent is valid for two years from the date of publication of this notice. |
Dated this 10th day of November 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz