2616

NEW ZEALAND GAZETTE, No. 98

6 SEPTEMBER 2007

Schedule

Product: Thalidomide Pharmion

Active Ingredient: Thalidomide 50mg

Dosage Form: Capsule

New Zealand Sponsor: Douglas Pharmaceuticals Limited

Manufacturer: Penn Pharmaceuticals Limited, Tafarnaubach Industrial Estate, Tredegar, Gwent, United Kingdom

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

• Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
• Douglas Pharmaceuticals Limited will manage the risk management programme relating to the distribution and use of Thalidomide.

Note: This consent is valid for two years from 18 December 2007.

Dated this 30th day of August 2007.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go5907

Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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: Replagal

Active Ingredient: Agalsidase alfa 1mg/mL

Dosage Form: Concentrate for infusion

New Zealand Sponsor: St Ives Medical

Manufacturer: Chesapeake Biological Laboratories Inc (CBL), Camden Industrial Park, Maryland, United States of America

Note: This consent is valid for two years from 25 August 2007.

Dated this 30th day of August 2007.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go6090

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: Clobex Shampoo

Active Ingredient: Clobetasol propionate 0.5mg/g

Dosage Form: Shampoo

New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer: Laboratoires Galderma, ZI – Montdésir, (previously Batiment 1), Alby-Sur-Chéran, France

Product: Nurofen Migraine 400 Double Strength

Active Ingredient: Ibuprofen lysinate 684mg equivalent to 400mg ibuprofen

Dosage Form: Film coated tablet

New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited

Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom

Product: Venlafaxine – Rex

Active Ingredient: Venlafaxine hydrochloride 170mg equivalent to 150mg venlafaxine

Dosage Form: Modified release capsule

New Zealand Sponsor: REX Medical Limited

Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka – Daund, District – Pune, Maharashtra State, India

Product: Venlafaxine – Rex

Active Ingredient: Venlafaxine hydrochloride 42.5mg equivalent to 37.5mg venlafaxine

Dosage Form: Modified release capsule

New Zealand Sponsor: REX Medical Limited

Manufacturer: Cipla Limited, Manufacturing Division, District – Pune, Maharashtra State, India