16 MARCH
NEW ZEALAND GAZETTE
605

Corrigendum

Renewal of Provisional Consent to the Distribution of a New Medicine

In the notice published in the New Zealand Gazette, 17 February 2000, Issue No. 13, page 321, notice No. 1121 for Coumadin tablets add between lines 10 and 11, 16 and 17, and 22 and 23 Condition: Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Dated this 8th day of March 2000.

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

go1752

Corrigendum

Renewal of Provisional Consent to the Distribution of a New Medicine

In the notice published in the New Zealand Gazette, 27 January 2000, Issue No. 7, page 180, notice No. 649 for Vesanoid capsule add between lines 10 and 11 Condition: The medicine may only be prescribed by: (a) medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branch of internal medicine and/or pathology; and (b) medical practitioners employed as registrars in internal medicine and/or pathology who are under the supervision of persons of the kind referred to in paragraph (a) above.

Dated this 8th day of March 2000.

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

go1753

Corrigendum

Renewal of Provisional Consent to the Distribution of a New Medicine

In the notice published in the New Zealand Gazette, 4 February 1999, Issue No. 16, page 366, notice No. 877 for Clozaril tablets in line 6 replace the word “Clozapine” with the words “The medicine”.

Dated this 8th day of March 2000.

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

go1750

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 set out in the schedule hereto:

Schedule

Product: Apo-Captopril
Active Ingredient(s): Captopril 12.5mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada

Product: Apo-Captopril
Active Ingredient(s): Captopril 25mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada

Product: Apo-Captopril
Active Ingredient(s): Captopril 50mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada

Product: Cilicaine VK 250
Active Ingredient(s): Phenoxymethylpenicillin potassium 277.18mg equivalent to 250mg phenoxymethyl penicillin
Dosage Form: Capsule
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia

Product: Cilicaine VK 500
Active Ingredient(s): Phenoxymethylpenicillin potassium 544.37mg equivalent to 500mg phenoxymethyl penicillin
Dosage Form: Capsule
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia

Product: Nifedipine 20mg
Active Ingredient(s): Nifedipine 20mg
Dosage Form: Modified release tablet
NZ Sponsor: Hexal New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany