✨ Medicine Distribution Consents




12 MAY 2011 NEW ZEALAND GAZETTE, No. 64 1487

Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India

Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India

Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India

Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India

Product: Ranbaxy-Gabapentin
Active Ingredient: Gabapentin 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India

Dated this 4th day of May 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Iressa
Active Ingredient: Gefitinib 250mg
Dosage Form: Coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca UK Limited, Cheshire, United Kingdom

Dated this 4th day of May 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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: RiaSTAP
Active Ingredient: Fibrinogen 900mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Behring GmbH, Marburg, Germany

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

Dated this 4th day of May 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 64





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Ranbaxy-Gabapentin Medicines

πŸ₯ Health & Social Welfare
4 May 2011
Medicines Act 1981, Gabapentin, Capsule, Film coated tablet, Douglas Pharmaceuticals Limited, Ranbaxy Laboratories Limited
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of Iressa Medicine

πŸ₯ Health & Social Welfare
4 May 2011
Medicines Act 1981, Iressa, Gefitinib, Coated tablet, AstraZeneca Limited
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of RiaSTAP Medicine

πŸ₯ Health & Social Welfare
4 May 2011
Medicines Act 1981, RiaSTAP, Fibrinogen, Powder for injection, CSL Biotherapies (NZ) Limited
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health