New Zealand Gazette – 1999 – No. 189

Page 4474

✨ Medicines Consent Notices

4474 No. 189

NEW ZEALAND GAZETTE

Manufacturer(s): Boehringer Ingelheim Pharmaceuticals Inc, Danbury, Connecticut, United States of America.
Roxane Laboratories Inc, Columbus, Ohio, United States of America.

Note: This consent is valid for 2 years from 4 December 1999.
Dated this 1st day of December 1999.

S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Efexor-XR.
Active Ingredient(s): Venlafaxine hydrochloride 169.7 mg equivalent to 150 mg venlafaxine.
Dosage Form: Modified release capsule.
NZ Sponsor: Wyeth (NZ) Limited.
Manufacturer(s): Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico.

Product: Efexor-XR.
Active Ingredient(s): Venlafaxine hydrochloride 84.85 mg equivalent to 75 mg venlafaxine.
Dosage Form: Modified release capsule.
NZ Sponsor: Wyeth (NZ) Limited.
Manufacturer(s): Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico.

Product: Recombinate.
Active Ingredient(s): Factor VIII (recombinant) 1000 IU.
Dosage Form: Powder for injection.
NZ Sponsor: Baxter Healthcare Limited.
Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America.
Baxter Healthcare Corporation, Los Angeles, United States of America.

Product: Recombinate.
Active Ingredient(s): Factor VIII (recombinant) 250 IU.
Dosage Form: Powder for injection.
NZ Sponsor: Baxter Healthcare Limited.
Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America.
Baxter Healthcare Corporation, Los Angeles, United States of America.

Product: Recombinate.
Active Ingredient(s): Factor VIII (recombinant) 500 IU.
Dosage Form: Powder for injection.
NZ Sponsor: Baxter Healthcare Limited.
Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America.
Baxter Healthcare Corporation, Los Angeles, United States of America.

Product: Risperdal.
Active Ingredient(s): Risperidone 1 mg/mL.
Dosage Form: Oral solution.
NZ Sponsor: Janssen-Cilag Pty Limited.
Manufacturer(s): Janssen Pharmaceutica NV, Plant 1, Beerse, Belgium.

Product: Risperdal.
Active Ingredient(s): Risperidone 1 mg.
Dosage Form: Film coated tablet.
NZ Sponsor: Janssen-Cilag Pty Limited.
Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium.
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy.

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VUW Te Waharoa — NZ Gazette 1999, No 189

NZLII — NZ Gazette 1999, No 189

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Renewal of Provisional Consent for New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated1 December 1999
KeywordsMedicines Act, Bretylium Tosylate, Viramune, Abbott Laboratories, Boehringer Ingelheim
👩‍💼 Officials

S. S. Jessamine, Acting Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines Act, Efexor-XR, Recombinate, Risperdal, Wyeth, Baxter Healthcare, Janssen-Cilag

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