β¨ 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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VUW Te Waharoa —
NZ Gazette 1996, No 115
NZLII —
NZ Gazette 1996, No 115
β¨ LLM interpretation of page content
π₯ Consent to Distribution of Changed Medicines
π₯ Health & Social Welfare9 September 1996
Medicines Act 1981, changed medicines, distribution consent, vaccines, tablets, injections
- HUGH BABER, Assistant General Manager, Health Regulation and Protection
π₯ Consent to Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act 1981, new medicines, distribution consent, antibiotics, vaccines, test kits