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
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bexsero
Neisseria meningitidis group B factor H binding protein fusion protein 50mcg
Neisseria meningitidis group B neisseria adhesin A protein 50mcg
Neisseria meningitidis group B neisseria heparin binding antigen fusion protein 50mcg
Neisseria meningitidis sergroup B outer membrane vesicles 25mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Vaccines SRL, Sovicille, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dilantin Infatabs
Phenytoin 50mg
Chewable tablet
Pfizer New Zealand Limited
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Parnate
Tranylcypromine sulfate 13.68mg equivalent to tranylcypromine 10mg
Film coated tablet
Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Dales Pharmaceuticals Limited, Skipton, United Kingdom
Recipharm Limited, Ashton-Under-Lyne, United Kingdom
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Dated this 17th day of April 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz