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: Cyklokapron
Active Ingredient: Tranexamic acid 500mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia SrL, Ascoli Piceno, Italy
Product: Cyklokapron
Active Ingredient: Tranexamic acid 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Product: Glypressin
Active Ingredient: Terlipressin acetate 1mg equivalent to terlipressin 0.86mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring GmbH, Kiel, Germany
Rentschler Biotechnologie GmbH, Laupheim, Germany
Product: Glypressin
Active Ingredient: Terlipressin acetate 1mg/8.5mL equivalent to terlipressin 0.1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Zentiva AS (Czech Republic), Prague, Czech Republic
Dated this 6th day of September 2012.
DR DON MACKIE, 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).