10 JUNE 2010 NEW ZEALAND GAZETTE, No. 64 1853

Medicines Act 1981

Corrigendum—Consent to the Distribution of New Medicines

In the notice with the above heading published in the New Zealand Gazette, 12 November 2009, No. 164, page 3972, the entry for Priligy is to be deleted from Full Consent section 20, and be placed in Provisional Consent section 23 as hereunder.

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to 60mg dapoxetine
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
Note: This consent is valid for two years from 12 November 2009.

Dated this 4th day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Rilutek
Active Ingredient: Riluzole 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France
Note: This consent is given subject to the following condition:

• Rilutek may only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Sodibic
Active Ingredient: Sodium bicarbonate 840mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Anekal Taluk, India
Note: This consent is valid for two years from the date of publication of this notice.

Dated this 3rd day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Creon 10000
Active Ingredient: Pancreatin 150mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Solvay Pharmaceuticals GmbH, Neustadt, Germany

Product: Creon Forte
Active Ingredient: Pancreatin 300mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Solvay Pharmaceuticals GmbH, Neustadt, Germany