Medicines Act Notices




NEW ZEALAND GAZETTE, No. 120

27 SEPTEMBER 2012


Health

Medicines Act 1981

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Actemra
Active Ingredient: Tocilizumab 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Chugai Pharmaceutical Co Limited, Tochigi, Japan

Dated this 19th day of September 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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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: DBL™ Metronidazole Intravenous Infusion
Active Ingredient: Metronidazole 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: ACS Dobfar Info SA, Campascio, Switzerland

Product: Dexmethsone
Active Ingredient: Dexamethasone 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Bangalore, India

Product: Efavirenz Alphapharm
Active Ingredient: Efavirenz 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Product: Lidocaine-Claris
Active Ingredient: Lidocaine hydrochloride monohydrate 10.66mg/mL equivalent to lidocaine hydrochloride 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India

Product: Lidocaine-Claris
Active Ingredient: Lidocaine hydrochloride monohydrate 21.32mg/mL equivalent to lidocaine hydrochloride 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India

Product: Ropibam
Active Ingredient: Ropivacaine hydrochloride, anhydrous 2mg/mL equivalent to ropivacaine 1.77mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy
Haemopharm Biofluids S.R.L, Tovo di Sant’Agata, Italy



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 120





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
19 September 2012
Medicines Act, New Medicine, Actemra, Roche Products
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines Act, New Medicines, DBL™ Metronidazole Intravenous Infusion, Dexmethsone, Efavirenz Alphapharm, Lidocaine-Claris, Ropibam