Medicine Distribution Consents




4510 NEW ZEALAND GAZETTE, No. 188 17 DECEMBER 2009

Schedule

Product:
Priligy

Active Ingredient:
Dapoxetine hydrochloride 33.6mg equivalent to 30mg dapoxetine

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited

Manufacturer:
Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico

Dated this 11th day of December 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding 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 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).

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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 set out in the Schedule hereto:

Schedule

Product:
Arrow - Carvedilol

Active Ingredient:
Carvedilol 3.125mg

Dosage Form:
Tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Elpen SA, Pikermi Attica, Greece

Product:
Arrow - Carvedilol

Active Ingredient:
Carvedilol 6.25mg

Dosage Form:
Tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Elpen SA, Pikermi Attica, Greece

Product:
Arrow - Carvedilol

Active Ingredient:
Carvedilol 12.5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Elpen SA, Pikermi Attica, Greece



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 188





✨ LLM interpretation of page content

🏥 Corrigendum—Consent to the Distribution of a New Medicine (continued from previous page)

🏥 Health & Social Welfare
11 December 2009
Medicines Act, New medicine, Provisional Consent, Priligy
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
11 December 2009
Medicines Act, New medicine, Provisional Consent, Oratane, Isotretinoin
  • ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
11 December 2009
Medicines Act, New medicines, Provisional Consent, Arrow - Carvedilol, Carvedilol
  • ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health