✨ Medicine Consents




208 NEW ZEALAND GAZETTE No. 7

Product:
Rebif
Active Ingredient:
Interferon beta-1a (rch) 22Β΅g equivalent to 6 MIU
Dosage Form:
Solution for injection
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturer:
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product:
Rebif
Active Ingredient:
Interferon beta-1a (rch) 44Β΅g equivalent to 12 MIU
Dosage Form:
Solution for injection
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturer:
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Dated this 16th day of January 2002.

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

go560


Provisional Consent to the Distribution of a New Medicine

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

Schedule

Product:
Kaletra
Active Ingredient(s):
Lopinavir 133.3mg
Ritonavir 33.3mg
Dosage Form:
Soft gelatin capsule
New Zealand Sponsor:
Abbott Laboratories (NZ) Limited
Manufacturer:
R P Scherer Corporation, St Petersburg, Florida, United States of America

Note: This consent is valid for 2 years from the date of publication of this notice.

Product:
Kaletra
Active Ingredient(s):
Lopinavir 80mg/mL
Ritonavir 20mg/mL
Dosage Form:
Oral solution
New Zealand Sponsor:
Abbott Laboratories (NZ) Limited
Manufacturer:
Abbott Laboratories Limited, Queenborough, Kent, United Kingdom

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 16th day of January 2002.

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

go565


Provisional Consent to the Distribution of a New Medicine

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

Schedule

Product:
Fabrazyme
Active Ingredient:
Agalsidase beta - rch 37mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Medra Services Limited
Manufacturer(s):
Genzyme Corporation, Allston, Massachusetts, United States of America
Genzyme Corporation, Framingham, Massachusetts, United States of America

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 16th day of January 2002.

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

go561



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 7


Gazette.govt.nz PDF NZ Gazette 2002, No 7





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
16 January 2002
Medicines, Distribution Consent, Rebif, Interferon beta-1a, Douglas Pharmaceuticals
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Provisional Consent to Distribution of New Medicine

πŸ₯ Health & Social Welfare
16 January 2002
Medicines, Provisional Consent, Kaletra, Lopinavir, Ritonavir, Abbott Laboratories
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Provisional Consent to Distribution of New Medicine

πŸ₯ Health & Social Welfare
16 January 2002
Medicines, Provisional Consent, Fabrazyme, Agalsidase beta, Medra Services, Genzyme
  • G. R. Boyd, Chief Advisor, Safety and Regulation