Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Gutron
Active Ingredient: Midodrine hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Nycomed GmbH, Oranienburg, Germany
Nycomed Danmark ApS, Hvidovre, Denmark
Note: This renewed consent is valid for two years from 30 April 2012.
Product: Gutron
Active Ingredient: Midodrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Nycomed GmbH, Oranienburg, Germany
Nycomed Danmark ApS, Hvidovre, Denmark
Note: This renewed consent is valid for two years from 30 April 2012.
Product: Isentress
Active Ingredient: Raltegravir potassium 434.3mg equivalent to Raltegravir 400mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
MSD International GmbH (Singapore Branch), Singapore
Note: This renewed consent is valid for two years from 4 September 2012.
Product: Sodibic
Active Ingredient: Sodium bicarbonate 840mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Bangalore, India
Note: This renewed consent is valid for two years from 10 June 2012.
Dated this 11th day of April 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).