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 set out in the Schedule hereto:
Schedule
Product: Diclohexal
Active Ingredient: Diclofenac sodium 25mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Salutas Pharma GmbH, Barleben, Germany
Sandoz do Brasil Industria Farmaceutica Ltda, Parana, Brazil
Product: Diclohexal
Active Ingredient: Diclofenac sodium 50mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Salutas Pharma GmbH, Barleben, Germany
Sandoz do Brasil Industria Farmaceutica Ltda, Parana, Brazil
Dated this 22nd day of September 2009.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).