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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
5 Nov 2020

Tags

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

Notice Number

2020-go5108
Title
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File Type and Size
PDF (35 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 2020.
   
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 2020.


Dated this 5th day of November 2020.

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