✨ Medicines Approvals




2122 NEW ZEALAND GAZETTE, No. 82 19 JULY 2007

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: MabCampath
Active Ingredient: Alemtuzumab 30mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Note: This consent is valid for two years from the date of publication of this notice.

Product: Revatio
Active Ingredient: Sildenafil citrate 28.09mg equivalent to sildenafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Zone Industrielle, Poce Sur Cisse, France
Note: This consent is valid for two years from the date of publication of this notice.

Product: Sebivo
Active Ingredient: Telbivudine 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid for two years from the date of publication of this notice.

Dated this 16th day of July 2007.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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: Actilyse
Active Ingredient: Alteplase 10mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product: Actilyse
Active Ingredient: Alteplase 20mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product: Actilyse
Active Ingredient: Alteplase 50mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product: Epilim 100 Crushable
Active Ingredient: Sodium valproate 100mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Synthelabo Limited, Fawdon, Tyne & Wear, United Kingdom



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 82


Gazette.govt.nz PDF NZ Gazette 2007, No 82





✨ LLM interpretation of page content

πŸ₯ Provisional Consent for New Medicines

πŸ₯ Health & Social Welfare
16 July 2007
Medicines, Provisional Consent, Distribution, MabCampath, Revatio, Sebivo
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent for Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Changed Medicines, Actilyse, Epilim