✨ Medicines Distribution Consent




17 MAY

NEW ZEALAND GAZETTE

1135

Product:
Metalyse

Active Ingredient(s):
Tenecteplase 50mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited

Manufacturer(s):
Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany

Product:
Pacific Cefaclor 125

Active Ingredient(s):
Cefaclor (monohydrate) 26.22mg/mL equivalent to 25mg/mL cefaclor

Dosage Form:
Powder for oral suspension

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Merck Farma y Quimica SA, Poligono Merck, Mollet del Valles, Barcelona, Spain

Product:
Pacific Cefaclor 250

Active Ingredient(s):
Cefaclor (monohydrate) 52.45mg/mL equivalent to 50mg/mL cefaclor

Dosage Form:
Powder for oral suspension

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Merck Farma y Quimica SA, Poligono Merck, Mollet del Valles, Barcelona, Spain

Product:
Panadol Gel Tabs

Active Ingredient(s):
Paracetamol 500mg/dose

Dosage Form:
Coated tablet

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
Banner Pharmacaps Inc, Chatsworth, California 91311, United States of America
SmithKline Beecham (Australia) Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
SmithKline Beecham (Dungarvan) Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland

Dated this 7th day of May 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
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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:
Chirocaine

Active Ingredient(s):
Levobupivacaine hydrochloride 2.816mg/mL equivalent to 2.5mg/ml levobupivacaine

Dosage Form:
Solution for injection

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer(s):
Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire

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

Product:
Chirocaine

Active Ingredient(s):
Levobupivacaine hydrochloride 5.633mg/mL equivalent to 5mg/mL levobupivacaine

Dosage Form:
Solution for injection

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer(s):
Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire

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

Product:
Chirocaine

Active Ingredient(s):
Levobupivacaine hydrochloride 8.449mg/mL equivalent to 7.5mg/mL levobupivacaine

Dosage Form:
Solution for injection

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer(s):
Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Eire

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

Dated this 7th day of May 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 50


Gazette.govt.nz PDF NZ Gazette 2001, No 50





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
7 May 2001
Medicines Act 1981, New Medicines, Distribution Consent, Pharmaceuticals
  • G. R. BOYD, Chief Advisor, Safety and Regulation

πŸ₯ Provisional Consent to Distribution of Chirocaine

πŸ₯ Health & Social Welfare
7 May 2001
Medicines Act 1981, Provisional Consent, New Medicine, Chirocaine, Levobupivacaine
  • G. R. BOYD, Chief Advisor, Safety and Regulation