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: Institute of Drug Technology (Aust) Limited, Melbourne, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland
Note: This consent is given subject to the following conditions:
1. 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.
2. 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 2014.
Product: Thalomid
Active Ingredient: Thalidomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers: Institute of Drug Technology (Aust) Limited, Melbourne, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland
Note: This consent is given subject to the following conditions:
1. 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.
2. 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 2014.
Product: Thalomid
Active Ingredient: Thalidomide 150mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers: Institute of Drug Technology (Aust) Limited, Melbourne, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland
Note: This consent is given subject to the following conditions:
1. 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.
2. 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 2014.
Product: Thalomid
Active Ingredient: Thalidomide 200mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers: Institute of Drug Technology (Aust) Limited, Melbourne, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland
Note: This consent is given subject to the following conditions:
1. 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.
2. 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 2014.
Dated this 29th day of August 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).