✨ Medicines Approvals




NEW ZEALAND GAZETTE

No. 115

Health

Medicines Act 1981

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)
Hepatitis A inactivated 720 EU in 0.5 mL Injection, vial SmithKline Beecham Biologicals, Rixensart, Belgium Havrix Junior Vaccine
Hepatitis A inactivated 720 EU in 0.5 mL Injection, pre-filled syringe SmithKline Beecham Biologicals, Rixensart, Belgium Havrix Junior Vaccine
Cilazapril 0.5 mg, 1 mg, 2.5 mg, 5 mg Tablets F Hoffmann-La Roche Limited, Basle, Switzerland Inhibace
Pravastatin sodium 40 mg Tablet Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia Lipostat
Human Immunoglobulin G 320 mg in 2 mL, 800 mg in 5 mL (i.e. 16% w/v solution of IgG) Injection, vial CSL Limited, Broadmeadows, Victoria, Australia Normal Immunoglobulin (Human)
Paracetamol 250 mg Tablet, soluble SmithKline Beecham (Australia) Pty Limited, Ermington, New South Wales, Australia Panadol 6 + Years Soluble
Dipyridamole 200 mg Capsule, modified release Dr Karl Thomae GmbH., Biberach, Biberach an der Riss, Germany Persantin P L 200 Perlongets
Goserelin acetate equivalent to 10.8 mg goserelin Implant Zeneca Pharmaceuticals, Macclesfield, Cheshire, England Zoladex 10.8

Dated this 9th day of September 1996.

HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.

605874

Consent to the Distribution of New Medicines

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

Name and Strength Form Name and Address of Manufacturer Proprietary Name (if any)
Amoxicillin trihydrate 25 mg, clavulanic potassium 6.25 mg per mL in 100 mL Oral suspension Lek Pharmaceutical and Chemical Company, Ljubljana, Slovenia Amoxyclav
Amoxicillin trihydrate 50 mg, clavulanic potassium 12.5 mg per mL in 100 mL Oral suspension Lek Pharmaceutical and Chemical Company, Ljubljana, Slovenia Amoxyclav Forte
Sulphamethoxazole 400 mg, trimethoprim 80 mg Tablet Apotex Inc., Weston, Ontario, Canada Apo-Sulfatrim
Sulphamethoxazole 800 mg, trimethoprim 160 mg Tablet Apotex Inc., Weston, Ontario, Canada Apo-Sulfatrim DS
BCG vaccine (Danish strain 1331) 0.75 mg/1 mL and diluent Powder for injection, vial Statens Serum Institut, Copenhagen S, Denmark BCG-Vaccine SSI
Bovine serum albumin 0.6 mcg, Pregnancy goat anti-mouse polyclonal antibody 4.9 mcg, murine monoclonal antibody to Alpha hCG 0.9 mcg, murine monoclonal antibody to Beta hCG 1.8 mcg test kit Syntron Bioresearch Inc., Carlsbad, California, United States of America Crystal Clear
Cefuroxime sodium 1577.7 mg (equivalent to 1500 mg cefuroxime in 100 mL) Powder for infusion, bottle Eli Lilly Italia SpA., Sesto Fiorentino, Florence, Italy Keroxime


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✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
9 September 1996
Medicines Act 1981, changed medicines, distribution consent, vaccines, tablets, injections
  • HUGH BABER, Assistant General Manager, Health Regulation and Protection

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, new medicines, distribution consent, antibiotics, vaccines, test kits