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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
8 Nov 2024

Tags

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

Notice Number

2024-go5744
Title
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PDF (38 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: Levothyroxine
Active Ingredient: Levothyroxine sodium 0.05mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Custom Pharmaceuticals Limited (UK), Hove, United Kingdom

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

  • This product should only be prescribed to patients already taking this product who are known to be intolerant to all other levothyroxine containing products.
  • This product may also be prescribed to patients already taking this product who are not known to be intolerant to all other levothyroxine containing products, but for whom changing to another levothyroxine containing product is not clinically appropriate.
Note: This renewed consent is valid for two years from 11 November 2024.
Product: Levothyroxine
Active Ingredient: Levothyroxine sodium 0.1mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Custom Pharmaceuticals Limited (UK), Hove, United Kingdom

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

  • This product should only be prescribed to patients already taking this product who are known to be intolerant to all other levothyroxine containing products.
  • This product may also be prescribed to patients already taking this product who are not known to be intolerant to all other levothyroxine containing products, but for whom changing to another levothyroxine containing product is not clinically appropriate.
Note: This renewed consent is valid for two years from 11 November 2024.
Product: Thalomid
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited, a Bristol Myers Squibb company
Manufacturer: 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 2024.
Product: Thalomid
Active Ingredient: Thalidomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited, a Bristol Myers Squibb company
Manufacturer: 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 2024.


Dated this 7th day of November 2024.

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