β¨ Medicines Distribution Consents
27 MARCH NEW ZEALAND GAZETTE 707
| Name and Strength | Form | Name and Address of Manufacturer | Proprietary Name (if any) |
|---|---|---|---|
| Water for injection in 500 mL, | Injection, | B Braun Pharmaceutical Industries Snd Bhd, | Water for Injection |
| 1000 mL | bottle | Bayan Lepas, Penang, Malaysia | |
| 200IU Zoster immunoglobulin | Injection, | C S L Limited, Broadmeadows, Victoria, | Zoster |
| (human) per 2 mL in a 16% | solution, | Australia | Immunoglobulin |
| w/v solution of IgG | ampoule | (Human) |
Dated this 18th day of March 1997.
g01765
Renewal of Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
| Name and Strength | Form | Name and Address of Manufacturer | Proprietary Name (if any) |
|---|---|---|---|
| Factor VIII 250IU and diluent | Injection, | CSL Limited, Broadmeadows, Victoria, Australia | AHF (High Purity) |
| Note: This consent is valid for | powder, vial; | Dried Factor VIII | |
| 2 years from the 25th day of | Diluent, | Fraction | |
| February 1997. | ampoule |
Dated this 18th day of March 1997.
g01763
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) |
|---|---|---|---|
| Diltiazem hydrochloride | Tablet, slow | Fering AB, Malmo, Sweden | Dilzem SR |
| 180 mg, 240 mg, 300 mg | release | ||
| Note: Not to be marketed as | |||
| substitutable for any other | |||
| slow release diltiazem tablets | |||
| as if the two (2) products | |||
| were bioequivalent. | |||
| Nicotine 2 mg, 4 mg | Chewing gum | Fertin Laboratories S/A., Vejle, Denmark | Nicotinell (Mint Flavour) |
| Nicotine 2 mg, 4 mg | Chewing gum | Fertin Laboratories S/A., Vejle, Denmark | Nicotinell (Original Flavour) |
| Cyclosporin A 100 mg/mL in | Solution, oral | Sandoz Pharma Limited, Basle, Switzerland | Sandimmun-Neoral |
| 50 mL | |||
| Cyclosporin A 25 mg, 50 mg, | Capsules | Sandoz Pharma Limited, Basle, Switzerland and | Sandimmun-Neoral |
| 100 mg | R P Scherer GmbH., Eberbach/Baden, Germany |
Dated this 18th day of March 1997.
g01764
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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
(continued from previous page)
π₯ Health & Social Welfare18 March 1997
Medicines Act, Approval, Pharmaceuticals, Distribution
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare18 March 1997
Medicines Act, Provisional Consent, Renewal, Pharmaceuticals
π₯ Consent to the Distribution of Changed Medicines
π₯ Health & Social Welfare18 March 1997
Medicines Act, Changed Medicines, Distribution, Pharmaceuticals