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: Cymbalta
Active Ingredient: Duloxetine hydrochloride 33.7mg equivalent to duloxetine base 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co Inc, Indiana, United States of America
Product: Cymbalta
Active Ingredient: Duloxetine hydrochloride 67.3mg equivalent to duloxetine base 60mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co Inc, Indiana, United States of America
Product: Estrofem
Active Ingredient: Oestradiol hemihydrate 1.03mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Estrofem
Active Ingredient: Oestradiol hemihydrate 2.07mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Humalog (Cartridge)
Active Ingredient: Insulin lispro 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France SAS, Fegersheim, France
Eli Lilly Italia SpA, Florence, Italy
Product: Humalog (Vial)
Active Ingredient: Insulin lispro 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly Technology Center, Indiana, United States of America
Lilly France SAS, Fegersheim, France
Product: Kliogest
Active Ingredients: Norethisterone acetate 1mg
Oestradiol hemihydrate 2.07mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, M†løv, Denmark
Product: Kliovance
Active Ingredients: Norethisterone acetate 0.5mg
Oestradiol hemihydrate 1.03mg equivalent to oestradiol 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Trisequens (Combination pack)
Kliogest Tablet
Active Ingredients: Norethisterone acetate 1mg
Oestradiol hemihydrate 2.07mg
Dosage Form: Film coated tablet
Estrofem 1mg Tablet
Active Ingredient: Oestradiol hemihydrate 1.03mg
Dosage Form: Tablet
Estrofem 2mg Tablet
Active Ingredient: Oestradiol hemihydrate 2.07mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Vagifem
Active Ingredient: Oestradiol hemihydrate 25.8µg equivalent to oestradiol 25µg
Dosage Form: Vaginal tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, M†løv, Denmark
Dated this 26th 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).