Notice Type
Departmental
Notice Title

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 is 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: Oratane
Active Ingredient: Isotretinoin 40mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Swiss Caps AG, Kirchberg, Switzerland
Ayanda GmbH & Co. KG, Pritzwalk, Germany
Product: Oratane
Active Ingredient: Isotretinoin 20mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Swiss Caps AG, Kirchberg, Switzerland
Ayanda GmbH & Co. KG, Pritzwalk, Germany
Product: Oratane
Active Ingredient: Isotretinoin 10mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Swiss Caps AG, Kirchberg, Switzerland
Ayanda GmbH & Co. KG, Pritzwalk, Germany
Dated this 11th day of December 2009.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).