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:

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 17 November 2022

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:

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 17 November 2022

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:

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 17 November 2022

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:

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 17 November 2022