✨ Medicines Notices




NEW ZEALAND GAZETTE, No. 148 β€” 11 DECEMBER 2014

$30.01 and greater $5.62 p&p
Copies are also available over the counter at the following locations:
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Bennetts Bookshops: Manukau Institute of Technology, Gate 11, NP Block, Otara Road, Manukau; University of Waikato, Gate 5, Hillcrest Road, Hamilton; Bennetts University Bookshop, Massey University, Palmerston North; Christchurch Polytechnic Institute of Technology, Madras Street, Christchurch; University Bookshop Canterbury Limited, University Drive, Ilam, Christchurch 8041.
Whitcoulls: 38–42 Broadway Avenue, Palmerston North.

2014-dl7650

Departmental

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

Product: Bretaris Genuair
Active Ingredient: Aclidinium bromide 375mcg equivalent to Aclidinium 322mcg
Dosage Form: Powder for inhalation
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Industrias Farmaceuticas Almirall SA (IFA), Barcelona, Spain

Product: Vancomycin Sandoz
Active Ingredient: Vancomycin hydrochloride 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Lek Pharmaceuticals d.d., Ljubljana, Slovenia
Hemofarm AD, Vrsac, Serbia

Product: Vancomycin Sandoz
Active Ingredient: Vancomycin hydrochloride 1000mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Lek Pharmaceuticals d.d., Ljubljana, Slovenia
Hemofarm AD, Vrsac, Serbia

Dated this 3rd day of December 2014.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2014-go7508

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Rilutek
Active Ingredient: Riluzole 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 148





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
3 December 2014
Medicines, Distribution, Consent, Bretaris Genuair, Vancomycin Sandoz
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
Medicines, Provisional Consent, Renewal, Rilutek