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:
Schedule
| Product: |
Thalomid |
| Active Ingredient: |
Thalidomide 50mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Celgene Limited |
| Manufacturers: |
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland |
|
Note: This consent is given subject to the following conditions:
- Thalidomide 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 and practice of internal medicine.
- Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.
|
| Note: This renewed consent is valid for two years from 25 November 2020. |
| |
|
| Product: |
Thalomid |
| Active Ingredient: |
Thalidomide 100mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Celgene Limited |
| Manufacturers: |
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland |
|
Note: This consent is given subject to the following conditions:
- Thalidomide 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 and practice of internal medicine.
- Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.
|
| Note: This renewed consent is valid for two years from 25 November 2020. |
| |
|
| Product: |
Thalomid |
| Active Ingredient: |
Thalidomide 150mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Celgene Limited |
| Manufacturers: |
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland |
|
Note: This consent is given subject to the following conditions:
- Thalidomide 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 and practice of internal medicine.
- Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.
|
| Note: This renewed consent is valid for two years from 25 November 2020. |
| |
|
| Product: |
Thalomid |
| Active Ingredient: |
Thalidomide 200mg |
| Dosage Form: |
Capsule |
| New Zealand Sponsor: |
Celgene Limited |
| Manufacturers: |
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland |
|
Note: This consent is given subject to the following conditions:
- Thalidomide 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 and practice of internal medicine.
- Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.
|
| Note: This renewed consent is valid for two years from 25 November 2020. |
Dated this 13th day of November 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz