Notice Title

Consent to the Distribution of New Medicines

Publication Date
1 Sep 2022

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2022-go3675
Title
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File Type and Size
PDF (35 KB)

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution 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 are set out in the Schedule hereto:

Schedule

Product: Nimenrix
Active Ingredients: Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5mcg
Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5mcg
Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5mcg
Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5mcg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Wavre, Belgium
Pfizer Manufacturing Belgium NV, Puurs, Belgium
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 11.2mg equivalent to octreotide 10mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 22.4mg equivalent to octreotide 20mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Octreotide Depot
Active Ingredient: Octreotide acetate 33.6mg equivalent to octreotide 30mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Sabril
Active Ingredient: Vigabatrin 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon France SA, Bourgoin-Jallieu, France


Dated this 29th day of August 2022.

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