β¨ Medicines Distribution Consent
NEW ZEALAND GAZETTE
No. 1
New Zealand Sponsor:
Pfizer Laboratories Limited
Manufacturers:
Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product:
Aricept
Active Ingredient:
Donepezil hydrochloride 5mg equivalent to 4.56mg donepezil free base
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Pfizer Laboratories Limited
Manufacturers:
Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France
The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product:
Cervidil
Active Ingredient:
Dinoprostone 10mg
Dosage Form:
Pessary
New Zealand Sponsor:
Baxter Healthcare Limited
Manufacturer:
Controlled Therapeutics (Scotland) Limited, 1 Peel Park Campus, East Kilbride, United Kingdom
Product:
Isotane 10
Active Ingredient:
Isotretinoin 10mg
Dosage Form:
Soft gelatin capsule
New Zealand Sponsor:
Pacific Pharmaceuticals Limited
Manufacturers:
R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Product:
Isotane 20
Active Ingredient:
Isotretinoin 20mg
Dosage Form:
Soft gelatin capsule
New Zealand Sponsor:
Pacific Pharmaceuticals Limited
Manufacturers:
R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Product:
Isotane 5
Active Ingredient:
Isotretinoin 5mg
Dosage Form:
Soft gelatin capsule
New Zealand Sponsor:
Pacific Pharmaceuticals Limited
Manufacturers:
R P Scherer Limited, Blagrove, Swindon, Wiltshire, United Kingdom
R P Scherer SA, Beinheim, France
Dated this 23rd day of December 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
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Consent to the Distribution of Changed Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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:
Enbrel
Active Ingredient:
Etanercept 25mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Wyeth (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product:
Epaxal Berna
Active Ingredient:
Hepatitis A vaccine 500RIA U
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Pharmabroker Sales Limited
Manufacturer:
Berna Biotech AG, Berne, Switzerland
Product:
Norditropin PenSet 12
Active Ingredient:
Somatropin 12IU
Dosage Form:
Powder for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Ltd
Manufacturer:
Novo Nordisk A/S, Gentofte, Denmark
Next Page →
Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2003, No 1
Gazette.govt.nz —
NZ Gazette 2003, No 1
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social WelfareMedicines Act 1981, Distribution Consent, Aricept, Donepezil hydrochloride, Cervidil, Dinoprostone, Isotane, Isotretinoin
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Consent to the Distribution of Changed Medicines
π₯ Health & Social WelfareMedicines Act 1981, Distribution Consent, Enbrel, Etanercept, Epaxal Berna, Hepatitis A vaccine, Norditropin PenSet 12, Somatropin