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: Duovisc
Active Ingredients: Chondroitin sulfate A 40mg/mL
Sodium hyaluronate 30mg/mL
Dosage Form: Viscoat Solution for injection
Active Ingredient: Sodium hyaluronate 10mg/mL
Dosage Form: Provisc Solution for injection
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: Glypressin
Active Ingredient: Terlipressin acetate 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring GmbH, Kiel, Germany
Rentschler Biotechnologie GmbH, Laupheim, Germany
Product: Provisc
Active Ingredient: Sodium hyaluronate 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: RotaTeq
Active Ingredients: Rotavirus reassortant strain G1 2200000IU/dose
Rotavirus reassortant strain G2 2800000IU/dose
Rotavirus reassortant strain G3 2200000IU/dose
Rotavirus reassortant strain G4 2000000IU/dose
Rotavirus reassortant strain P1 2300000IU/dose
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Dated this 20th day of November 2009.
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).