β¨ 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 —
NZ Gazette 2007, No 82
Gazette.govt.nz —
NZ Gazette 2007, No 82
β¨ LLM interpretation of page content
π₯ Provisional Consent for New Medicines
π₯ Health & Social Welfare16 July 2007
Medicines, Provisional Consent, Distribution, MabCampath, Revatio, Sebivo
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent for Distribution of Changed Medicines
π₯ Health & Social WelfareMedicines, Distribution, Changed Medicines, Actilyse, Epilim