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) Cyclophosphamide monohydrate 53.5 mg equivalent to 50 mg cyclophosphamide Tablet Asta Medica AG., Halle-Kunsebeck, Germany Endoxan-Asta Trandolapril 0.5 mg, 1 mg, 2 mg Capsules Roussel-Uclaf Usiphar Production Unit, Compeigne, France Gopten Ethinyloestradiol 20 g, gestodene 75 g Tablet Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia and Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland Harmonent 21 Ethinyloestradiol 20 g, gestodene 75 g Tablet Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia and Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland Harmonent 28 Loperamide hydrochloride 2 mg Tablet Ortho McNeil Pharmaceuticals, Mameyal, Dorado, Puerto Rico Imodium Caplets Tinzaparin sodium 10 000, 20 000 anti-Xa IU/mL Injection, pre-filled syringe Leo Pharmaceutical Products, Ballerup, Denmark and Laboratories Leo SA., Vernouillet, France Innohep Tinzaparin sodium 10 000, 20 000 anti-Xa IU/mL in 2 mL Injection, vials Leo Pharmaceutical Products, Ballerup, Denmark and Laboratories Leo SA., Vernouillet, France Innohep Pravastatin sodium 5 mg, 10 mg, 20 mg, 40 mg Tablets Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia Lipostat Trandolapril 0.5 mg, 1 mg, 2 mg Capsules Roussel-Uclaf Usiphar Production Unit, Compeigne, France Odrik Epoetin beta 10 000 IU (83 g) Injection, powder for, cartridge; and diluent Vetter Pharma-Fertigung GmbH & Co Kg., Ravensburg, Germany Recormon 10 000 for Reco-Pen Epoetin beta 20 000 IU (166 g) Injection, powder for, cartridge; and diluent Vetter Pharma-Fertigung GmbH & Co Kg., Ravensburg, Germany Recormon 20 000 for Reco-Pen Risperidone 1 mg, 2 mg, 3 mg, 4 mg, 6 mg, 8 mg Tablets Janssen Pharmaceutica nv., Beerse, Belgium and Janssen Cilag SpA., Borgo S. Michele, Latina, Italy Risperdal Risperidone 1 mg/mL Solution, oral Janssen Pharmaceutica nv., Beerse, Belgium Risperdal Interferon alpha-2a 3, 4.5, 6, 9 million IU/per mL; 18 million IU/3 mL in 3 mL Injection, vial F Hoffmann-La Roche Limited, Basle, Switzerland Roferon-A Interferon alpha-2a 3, 4.5, 6, 9 million IU/per 0.5 mL Injection, pre-filled syringe F Hoffmann-La Roche Limited, Basle, Switzerland Roferon-A Estradiol 0.1% Transdermal gel Orion Corporation Farmos, Turku, Finland Sandrena Salmeterol xinafoate 72.5 g/dose equivalent to 50 g/dose salmeterol Powder, inhaled, oral Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom Serevent Accuhaler Salmeterol xinafoate 25 g/dose Spray, oral, metered dose Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom; Glaxo Wellcome Production, Evreux, France and Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom Serevent Inhaler Salmeterol xinafoate 50 g/dose Powder, inhaled, oral Glaxo Wellcome Production, Evreux, France and Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom Serevent Rotadisk Itraconazole 100 mg Capsule Janssen Biotech nv., Olen, Belgium; Janssen Pharmaceutica nv., Beerse, Belgium; Janssen Cilag SpA., Borgo S. Michele, Latina, Italy and Le Laboratoire Prographarm, Chateuneuf-en-Thymerais, France Sporanox Azathioprine 50 mg Tablet Lennon Limited, Port Elizabeth, South Africa Thioprine Azathioprine 50 mg Tablet, film coated Generics (UK) Limited, Potters Bar, Hertfordshire, United Kingdom Thioprine Dated this 8th day of April 1998. 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
16 Apr 1998

Notice Number

1998-go2552

Page Number

1204