✨ Medicines Act Notices




16 NOVEMBER NEW ZEALAND GAZETTE 3993

Health

Medicines Act 1981

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Pralidoxime Iodide (PAM)
Active Ingredient(s): Pralidoxime iodide 25mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Australasia Pty Limited, Captain Cook Drive, Kurnell, New South Wales, Australia

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 8th day of November 2000.

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: Neurontin
Active Ingredient(s): Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany

Product: Neurontin
Active Ingredient(s): Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany

Product: Neurontin
Active Ingredient(s): Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany

Product: Neurontin
Active Ingredient(s): Gabapentin 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico

Product: Neurontin
Active Ingredient(s): Gabapentin 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Warner-Lambert Inc, Vega Baja, Puerto Rico

Dated this 8th day of November 2000.

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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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 154


Gazette.govt.nz PDF NZ Gazette 2000, No 154





✨ LLM interpretation of page content

πŸ₯ Provisional Consent to Distribute New Medicine

πŸ₯ Health & Social Welfare
8 November 2000
Medicines Act, Provisional Consent, Pralidoxime Iodide, Abbott Laboratories
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to Distribute Changed Medicines

πŸ₯ Health & Social Welfare
8 November 2000
Medicines Act, Changed Medicines, Neurontin, Gabapentin, Parke Davis
  • G. R. Boyd, Chief Advisor, Safety and Regulation