✨ Medicines Consent Notices




2 OCTOBER 2014

NEW ZEALAND GAZETTE, No. 119


Product: Benlysta
Active Ingredient: Belimumab 400mg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Hospira Inc, Kansas, United States of America

Product: Clobetasol Cream
Active Ingredient: Clobetasol propionate 0.5mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Tiofarma B.V, Oud-Beijerland, The Netherlands

Product: Clobetasol Ointment
Active Ingredient: Clobetasol propionate 0.5mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Tiofarma B.V, Oud-Beijerland, The Netherlands

Product: DermAssist
Active Ingredient: Hydrocortisone acetate 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore

Product: Herceptin SC
Active Ingredient: Trastuzumab 120mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland

Product: Indomethacin Agila
Active Ingredient: Indometacin sodium trihydrate 1.061mg equivalent to Indomethacin 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India

Product: Indomethacin IV Mylan
Active Ingredient: Indometacin sodium trihydrate 1.061mg equivalent to Indomethacin 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India

Dated this 25th day of September 2014.

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

go6059


Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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

Product: Alcaine
Active Ingredient: Proxymetacaine hydrochloride 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 25th day of September 2014.

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

go6060



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 119





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
25 September 2014
Medicines Act 1981, New Medicines, Consent to Distribution, Benlysta, Clobetasol, DermAssist, Herceptin SC, Indomethacin
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

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

πŸ₯ Health & Social Welfare
25 September 2014
Medicines Act 1981, Provisional Consent, New Medicine, Alcaine
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health