✨ 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



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2003, No 1


Gazette.govt.nz PDF NZ Gazette 2003, No 1





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
Medicines Act 1981, Distribution Consent, Aricept, Donepezil hydrochloride, Cervidil, Dinoprostone, Isotane, Isotretinoin
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, Distribution Consent, Enbrel, Etanercept, Epaxal Berna, Hepatitis A vaccine, Norditropin PenSet 12, Somatropin