Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Adalat Oros
Active Ingredient(s): Nifedipine 20mg
Dosage Form: Modified release tablet
NZ Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer(s): Alza Corporation, Vacaville, California, United States of America
Bayer AG, Leverkusen 1, Germany
Pfizer Pharmaceuticals Inc, Barceloneta, Puerto Rico
Product: Felopine ER 10
Active Ingredient(s): Felodipine 10mg
Dosage Form: Modified release tablet
NZ Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Omega Farma ehf, Reykjavik, Iceland
Product: Felopine ER 2.5
Active Ingredient(s): Felodipine 2.5mg
Dosage Form: Modified release tablet
NZ Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Omega Farma ehf, Reykjavik, Iceland
Product: Felopine ER 5
Active Ingredient(s): Felodipine 5mg
Dosage Form: Modified release tablet
NZ Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Omega Farma ehf, Reykjavik, Iceland
Product: Gonal-F 37.5IU
Active Ingredient(s): Follitropin alpha 37.5IU
Dosage Form: Injection with diluent
NZ Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Serono Pharma SpA, Zone Industriale di Modugno, Bari, Italy
Product: Naropin 2mg/mL with Fentanyl 2µg/mL
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 2mg/mL
Fentanyl citrate 3.14µg/mL equivalent to 2µg/mLFentanyl
Dosage Form: Solution for infusion
NZ Sponsor: AstraZeneca Limited
Manufacturer(s): Astra Pharmaceuticals Pty Ltd, North Ryde, New South Wales, Australia
Product: Naropin 2mg/mL with Fentanyl 4µg/mL
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 2mg/mL
Fentanyl citrate 6.28µg/mL equivalent to 4µg/mL fentanyl
Dosage Form: Solution for infusion
NZ Sponsor: AstraZeneca Limited
Manufacturer(s): Astra Pharmaceuticals Pty Ltd, North Ryde, New South Wales, Australia
Product: Optazine Fresh
Active Ingredient(s): Tetrahydrozoline hydrochloride 0.5mg/mL
Dosage Form: Eye drops, solution
NZ Sponsor: Whitehall Laboratories (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, Clayton, Victoria, Australia
Product: Robitussin ME
Active Ingredient(s): Bromhexine hydrochloride 0.8mg/mL
Guaiphenesin 20mg/mL
Dosage Form: Oral solution
NZ Sponsor: Whitehall Laboratories (NZ) Limited
Manufacturer(s): Soul Pattinson Manufacturing Pty Limited, Kingsgrove, New South Wales, Australia
Dated this 26th day of January 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).