β¨ Medicines Approval
NEW ZEALAND GAZETTE
No. 29
Health
Medicines Act 1981
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) |
|---|---|---|---|
| Sodium chloride 0.9 g per 100 mL in 10 mL, 20 mL | Solution, infusion, ampoule | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | 0.9% Sodium Chloride |
| Sodium chloride 0.9 g per 100 mL in 250 mL, 500 mL, 1000 mL | Solution, infusion, bottle | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | 0.9% Sodium Chloride |
| Dextrose monohydrate 5.0 g, sodium chloride 0.9 g per 100 mL in 500 mL, 1000 mL | Solution, infusion, bottle | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | 0.9% Sodium Chloride & 5% Glucose Injection |
| Dextrose monohydrate 50.0 g per 100 mL in 100 mL, 250 mL, 500 mL, 1000 mL | Solution, infusion, bottle | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | 5% Glucose Intravenous Infusion |
| Amoxycillin trihydrate 500 mg, clavulanate potassium 125 mg | Tablet | Lek Pharmaceutical & Chemical Co., Ljubljana, Slovenia | Amoxyclav |
| Day-time component: | Benadryl Day & Night | ||
| Dextromethorphan hydrobromide 10 mg/5 mL, pseudoephedrine hydrochloride 30 mg/5 mL in 100 mL | Syrup | Parke-Davis Pty Limited, Caringbah, New South Wales, Australia | |
| Night-time component: | |||
| Dextromethorphan hydrobromide 10 mg/5 mL, diphenhydramine hydrochloride 12.5 mg/5 mL, pseudoephedrine hydrochloride 30 mg/5 mL in 100 mL | Syrup | Parke-Davis Pty Limited, Caringbah, New South Wales, Australia | |
| Bupivacaine hydrochloride anhydrous equivalent to 0.25% w/v, 0.5% w/v bupivacaine hydrochloride | Injection, solution, ampoule | Antigen Pharmaceuticals Limited, Roscrea, Co Tipperary, Ireland | Bupivacaine Hydrochloride |
| Potassium chloride 0.27 g, sodium chloride 0.4 g, sodium lactate 0.58 g per 100 mL in 500 mL, 1000 mL | Solution, infusion, bottle | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | Darrow's Solution |
| Doxylamine succinate 25 mg | Capsule | R P Scherer Holdings Pty Limited, Braeside, Victoria, Australia | Dozile |
| Component 1: | Tablets | Solvay Duphar bv., Olst, The Netherlands | Femoston 2/10 |
| oestradiol 2 mg | |||
| Component 2: | |||
| oestradiol 2 mg, dydrogesterone 10 mg | |||
| Calcium chloride dihydrate 0.027 g, potassium chloride 0.04 g, sodium chloride 0.6 g, sodium lactate 0.312 g per 100 mL in 500 mL, 1000 mL | Solution, infusion, bottle | B Braun Pharmaceutical Industries Snd Bhd, Bayan Lepas, Penang, Malaysia | Hartmann's Solution |
| 100IU, 400IU Hepatitis B immunoglobulin in a 16% w/v solution of IgG | Injection, solution, vial | C S L Limited, Broadmeadows, Victoria, Australia | Hepatitis B Immunoglobulin |
| 625IU (125 mcg) Rh (D) immunoglobulin per mL in a 16% w/v solution of IgG | Injection, solution, vial | C S L Limited, Broadmeadows, Victoria, Australia | Rh (D) Immunoglobulin |
| 250IU Tetanus antitoxin in a 16% w/v solution of IgG | Injection, solution, vial | C S L Limited, Broadmeadows, Victoria, Australia | Tetanus Immunoglobulin |
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VUW Te Waharoa —
NZ Gazette 1997, No 29
NZLII —
NZ Gazette 1997, No 29
β¨ LLM interpretation of page content
π₯ Consent to Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act, Approval, Pharmaceuticals, Distribution