β¨ Medicines Consent Renewal
NEW ZEALAND GAZETTE, No. 93 β 13 OCTOBER 2016
Thalomid.
Note: This renewed consent is valid for two years from 25 November 2016.
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 2016.
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 2016.
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 2016.
Dated this 6th day of October 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
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β¨ LLM interpretation of page content
π₯
Renewal of Provisional Consent to the Distribution of Medicines
(continued from previous page)
π₯ Health & Social Welfare6 October 2016
Medicines, Provisional Consent, Renewal, Thalomid, Thalidomide, Medsafe, Ministry of Health
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2016, No 93