Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 58 — 23 JUNE 2016

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Esbriet
Pirfenidone 267mg
Capsule
Roche Products (NZ) Limited
Catalent Pharma Solutions LLC, Kentucky, United States of America

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Misodel
Misoprostol 200mcg
Pessary
Pharmaco (NZ) Limited
Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Misopess
Misoprostol 200mcg
Pessary
Pharmaco (NZ) Limited
Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom

Dated this 16th day of June 2016.

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

2016-go3522

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Pamol (strawberry flavour)
Paracetamol 50mg/mL
Oral suspension
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Ensign Laboratories Pty Limited, Melbourne, Australia

Dated this 16th day of June 2016.

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

2016-go3523

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
Clozaril
Clozapine 25mg
Tablet
Novartis New Zealand Limited
Novartis Pharmaceuticals UK Limited, Horsham, United Kingdom
Novartis Saglik ve Gida Urunlei Sanayi ve Ticaret AS, Istanbul, Turkey

Note: This consent is given subject to the following conditions:

  1. The medicine may only be prescribed by:
    • a medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (“psychiatrist”);
    • a medical practitioner or nurse practitioner who is prescribing under the supervision of a psychiatrist;

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 58





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
16 June 2016
Medicines Act, New Medicines, Health Regulation
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
16 June 2016
Medicines Act, New Medicine, Health Regulation
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Renewal of Provisional Consent to the Distribution of Medicines

🏥 Health & Social Welfare
16 June 2016
Medicines Act, Provisional Consent, Health Regulation
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health