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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
9 May 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go2115
Title
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PDF (40 KB)

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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and set out in the Schedule hereto:

Schedule

Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 3.025mg equivalent to lenalidomide 2.5mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 6.05mg equivalent to lenalidomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 9.075mg equivalent to lenalidomide 7.5mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 12.1mg equivalent to lenalidomide 10mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 18.15mg equivalent to lenalidomide 15mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 24.2mg equivalent to lenalidomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.
Product: Lenalidomide-Teva
Active Ingredient: Lenalidomide hydrochloride monohydrate 30.25mg equivalent to lenalidomide 25mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia

Provisional consent is granted until 15 September 2024.

This consent is given subject to the following conditions:

  1. Lenalidomide-Teva 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.
  2. Teva Pharma (New Zealand) Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide-Teva.


Dated this 6th day of May 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).