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: DuoTrav
Active Ingredients: Timolol maleate 6.8mg/mL equivalent to timolol 5mg/mL
Travoprost 40µg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturers: Alcon Laboratories Inc, Texas, United States of America
SA Alcon Couvreur NV, Puurs, Belgium
Product: Lucrin
Active Ingredient: Leuprorelin acetate 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Famar L’Aigle, Saint Remy-sur-Avre, France
Product: Lucrin Depot 1-Month
Active Ingredient: Leuprorelin acetate 3.75mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Osaka, Japan
Takeda Pharmaceutical Company Limited, Yamaguchi, Japan
Product: Lucrin Depot 3-Month
Active Ingredient: Leuprorelin acetate 11.25mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Osaka, Japan
Takeda Pharmaceutical Company Limited, Yamaguchi, Japan
Product: Lucrin Depot 6-month
Active Ingredient: Leuprorelin acetate 30mg
Dosage Form: Injection (depot)
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Takeda Pharmaceutical Company Limited, Osaka, Japan
Takeda Pharmaceutical Company Limited, Yamaguchi, Japan
Product: Premarin
Active Ingredient: Conjugated oestrogens 0.3mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Ireland Pharmaceuticals, County Kildare, Ireland
Wyeth Pharmaceuticals Inc, New York, United States of America
Product: Premarin
Active Ingredient: Conjugated oestrogens 0.625mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Ireland Pharmaceuticals, County Kildare, Ireland
Wyeth Pharmaceuticals Inc, New York, United States of America
Product: Travatan 0.004% Eye Drops
Active Ingredient: Travoprost 40µg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Dated this 19th day of May 2011.
PAT TUOHY, 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).