New Zealand Gazette – 2013 – No. 162

Page 4478

✨ Medicines Notices

NEW ZEALAND GAZETTE, No. 162

5 DECEMBER 2013

Medicines Act 1981

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: Kalydeco
Active Ingredient: Ivacaftor 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novotech (New Zealand) Limited
Manufacturer: Patheon Pharmaceuticals Inc, Ohio, United States of America

Product: LMX4
Active Ingredient: Lidocaine 4%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Ferndale Laboratories Inc, Michigan, United States of America

Product: MeniCare Soft
Active Ingredient: Polihexanide 0.0001%w/w
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France

Product: Meni-LAB
Active Ingredient: Sodium hypochlorite 0.524%w/v equivalent to active chlorine 0.5%
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France

Product: Orion RX Imiquimod Cream 5%
Active Ingredient: Imiquimod 50mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Israel Pharmaceuticals Limited, Yeruham, Israel

Dated this 28th day of November 2013.

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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Medicines Regulations 1984

Approved Sale of General Sales Medicines by Vending Machines (Approval No. 2013/AP016)

Pursuant to Regulation 59(1) of the Medicines Regulations 1984, I, Sue Scott, Team Leader, Medicines Control, on delegated authority* from the Director-General of Health, approve the sales of the following general sales medicines by vending machines:

Vending Machines

eVend CPC-01 vending machines operated by OCS Limited (trading as Cannon Hygiene), 26 Virginia Avenue East, Eden Terrace, Auckland 1021. Postal Address: PO Box 8122, Symonds Street, Auckland 1150.

General Sales Medicines

See Schedule 1 to Approval No. 2013/AP016 (attached).

Non-medicinal Products

Any products, including personal care items and designated foods must first be approved by the Team Leader, Medicines Control, before these items can be stored and sold in vending machines containing general sales medicines.

This approval is issued subject to the following conditions:

The approval applies only to the vending machines, general sales medicines and approved non-medicinal products (if any) specified in this document.
General sale medicines must be stored on upper shelves in the vending machine above all other approved items.
The vending machines must be located inside buildings, in clean, well-ventilated and well-lit areas, excluding toilet areas.
The approval must be available to be viewed by a Medicines Control Officer on request.

Gazette.govt.nz — NZ Gazette 2013, No 162

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated28 November 2013
KeywordsMedicines, Distribution, Consent, Kalydeco, LMX4, MeniCare Soft, Meni-LAB, Orion RX Imiquimod Cream
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Approval of General Sales Medicines by Vending Machines

Domain🏥 Health & Social Welfare
KeywordsMedicines, Vending Machines, Approval, eVend CPC-01, OCS Limited
👩‍💼 Officials

Sue Scott, Team Leader, Medicines Control

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