Notice Type
Departmental
Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto: Schedule Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) Epoetin alfa 16.8g/mL (2,000IU/mL), 33.6g/mL (4,000IU/mL), 84g/mL (10,000IU/mL) Injection, solution (vial) Cilag AG., Schaffhausen, Switzerland; and Janssen Pharmaceutica nv., Beerse, Belgium Eprex Epoetin alfa 16.8g/mL (2,000IU/mL), 33.6g/mL (4,000IU/mL), 84g/mL (10,000IU/mL) Injection, solution (pre-filled syringe) Cilag AG., Schaffhausen, Switzerland; Janssen Pharmaceutica nv., Beerse, Belgium; and Vetter-Pharma-Fertigung GmbH & Co Kg., Ravensburg, Germany Eprex Alendronate sodium trihydate 6.53 mg equivalent to 5 mg alendronic acid Tablet Merck Sharp & Dohme Italia SpA., Pavia, Italy Fosamax Factor VIII (recombinant) 250IU, 500IU, 1000IU and water for injection (as diluent) Injection, powder with diluent Bayer AG., Leverkusen, Germany; and Bayer Corporation Biological Products, Berkeley, California, United States of America Helixate Tinzaparin sodium 10,000 anti-Xa IU/mL, 20,000 anti-Xa IU/mL Injection, solution (pre-filled syringe) Leo Pharmaceutical Products, Ballerup, Denmark; and Laboratoires Leo SA., Vernouillet, France Innohep Tinzaparin sodium 10,000 anti-Xa IU/mL, 20,000 anti-Xa IU/mL Injection, solution (vial) Leo Pharmaceutical Products, Ballerup, Denmark; and Laboratoires Leo SA., Vernouillet, France Innohep Verapamil hydrochloride 40 mg, 80 mg Tablets, film coated Knoll AG., Ludwigshafen/Rhein, Germany; and Knoll AG., Liestal, Switzerland Isoptin Factor VIII (recombinant) 250IU, 500IU, 1000IU and water for injection (as diluent) Injection, powder with diluent Bayer AG., Leverkusen, Germany; and Bayer Corporation Biological Products, Berkeley, California, United States of America Kogenate Dated this 6th day of May 1999. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.
Publication Date
13 May 1999

Notice Number

1999-go3456

Page Number

1295