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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
21 Sep 2023

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2023-go4408
Title
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PDF (37 KB)

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: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan

Note: This consent is given subject to the following conditions:

  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Note: This renewed consent is valid for two years from 24 October 2023.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 10mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan

Note: This consent is given subject to the following conditions:

  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Note: This renewed consent is valid for two years from 24 October 2023.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 15mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan

Note: This consent is given subject to the following conditions:

  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Note: This renewed consent is valid for two years from 24 October 2023.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 25mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan

Note: This consent is given subject to the following conditions:

  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Note: This renewed consent is valid for two years from 24 October 2023.


Dated this 18th day of September 2023.

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