Notice Type
Departmental
Consent to the Distribution of a New Medicine 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: Carboplatin for Injection. Active Ingredient(s): Carboplatin 10 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): Laboratoires Thissen SA, Braine-L'Alleud, Belgium. Product: Clexane H P. Active Ingredient(s): Heparin sodium 150 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: Rhone-Poulenc Rorer New Zealand Limited. Manufacturer(s): Rhone-Poulenc Rorer Pharma Specialties, Maisons-Alfort, France. Product: Fluox. Active Ingredient(s): Fluoxetine hydrochloride 22.36 mg equivalent to 20 mg fluoxetine. Dosage Form: Capsule. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia. Product: Marcain with Fentanyl Epidural Infusion. Active Ingredient(s): Bupivacaine hydrochloride (monohydrate) 1.25 mg/mL. Fentanyl citrate 3.14 g/mL equivalent to 2 g/mL Fentanyl. Dosage Form: Solution for infusion. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Marcain with Fentanyl Epidural Infusion. Active Ingredient(s): Bupivacaine hydrochloride (monohydrate) 1.25 mg/mL. Fentanyl citrate 7.9 g/mL equivalent to 5 g/mL fentanyl. Dosage Form: Solution for infusion. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Mitoxantrone. Active Ingredient(s): Mitoxantrone hydrochloride 2.328 mg/mL equivalent to 2 mg/mL mitoxantrone free base. Dosage Form: Concentrate for injection. NZ Sponsor: Pharmacia & Upjohn. Manufacturer(s): Pharmacia & Upjohn (Perth) Pty Limited, Bentley, Western Australia, Australia. Dated this 10th day of November 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
18 Nov 1999

Notice Number

1999-go8422

Page Number

4100