✨ 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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πŸ₯ Consent to Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
18 March 1997
Medicines Act, Approval, Pharmaceuticals, Distribution

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
18 March 1997
Medicines Act, Provisional Consent, Renewal, Pharmaceuticals

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
18 March 1997
Medicines Act, Changed Medicines, Distribution, Pharmaceuticals