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 - HCQS
Active Ingredient: Hydroxychloroquine sulfate 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: CA - Hydroxychloroquine
Active Ingredient: Hydroxychloroquine sulfate 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Clonidine BNM
Active Ingredient: Clonidine hydrochloride 25mcg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: Bafna Pharmaceuticals Limited, Chennai, India
Tiofarma B.V, Oud-Beijerland, The Netherlands
Product: Evogam
Active Ingredient: Normal immunoglobulin 16%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Melbourne, Australia
Product: IPCA - Hydroxychloroquine
Active Ingredient: Hydroxychloroquine sulfate 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Lacdol
Active Ingredient: Lactulose 0.67g/mL
Dosage Form: Oral solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Dated this 12th day of December 2012.
DR STEWART JESSAMINE, 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).