✨ Medicines Consent Notices




11 MARCH 2010

NEW ZEALAND GAZETTE, No. 29

769

Product: Prezista
Active Ingredient: Darunavir 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Prezista
Active Ingredient: Darunavir 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Univent
Active Ingredient: Ipratropium bromide monohydrate 250ΞΌg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India

Dated this 5th day of March 2010.

MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go1856

Consent to the Distribution of New Medicines

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

Product: Vfend
Active Ingredient: Voriconazole 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany

Product: Vfend
Active Ingredient: Voriconazole 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany

Product: Vfend
Active Ingredient: Voriconazole 200mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Ireland Pharmaceuticals, Dublin, Ireland

Product: Vfend
Active Ingredient: Voriconazole 40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Poce Sur Cisse, France

Dated this 5th day of March 2010.

MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go1857

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Clopine
Active Ingredient: Clozapine 50mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 29





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
5 March 2010
Medicines Act 1981, New Medicines, Distribution Consent, Prezista, Univent
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
5 March 2010
Medicines Act 1981, New Medicines, Distribution Consent, Vfend
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Renewal of Provisional Consent to Distribution of a Medicine

πŸ₯ Health & Social Welfare
5 March 2010
Medicines Act 1981, Provisional Consent Renewal, Clopine
  • MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health