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 set out in the Schedule hereto:
Schedule
Product: Arrow - Ranitidine
Active Ingredient: Ranitidine hydrochloride 16.75mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Rosemont Pharmaceuticals Limited, Leeds, United Kingdom
Product: Benadryl Mucus Relief & Decongestant
Active Ingredients: Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Australia
Product: Dr Reddy’s Omeprazole
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
Product: Locacorten-Viaform
Active Ingredients: Clioquinol 1%w/v
Flumetasone pivalate 0.02%w/v
Dosage Form: Ear drops
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Famar SA, Athens, Greece
Product: Vidaza
Active Ingredient: Azacitidine 100mg
Dosage Form: Suspension for injection
New Zealand Sponsor: Celgene Pty Limited Quigg Partners
Manufacturers: Ben Venue Laboratories Inc, Bedford, United States of America
Baxter Oncology GmbH, Halle-Kunsebeck, Germany
Dated this 13th day of May 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).