β¨ Medicines Notices
13 FEBRUARY NEW ZEALAND GAZETTE 339
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Celapram
Citalopram hydrobromide 24.98mg equivalent to 20mg citalopram
Film coated tablet
Pacific Pharmaceuticals Limited
Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Cromolux
Sodium cromoglycate 2%w/v
Eye drops, solution
AFT Pharmaceuticals Limited
Tubilux Pharma SpA, Pomezia, Rome, Italy
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
Dynastat
Parecoxib sodium 21.18mg equivalent to 20mg parecoxib
Powder for injection
Pharmacia Limited Company
Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Pharmacia, Barceloneta, Puerto Rico
Wasserburger Arzneimittelwerk Dr Madaus GmbH, Wasserburg, Germany
Product:
Dynastat
Active Ingredient:
Parecoxib sodium 42.36mg equivalent to 40mg parecoxib
Dosage Form:
Powder for injection
New Zealand Sponsor:
Pharmacia Limited Company
Manufacturers:
Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Pharmacia, Barceloneta, Puerto Rico
Wasserburger Arzneimittelwerk Dr Madaus GmbH, Wasserburg, Germany
Product:
NovoMix 30 Flexpen
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product:
Penmix 30 Innolet
Active Ingredients:
Isophane insulin, human, pyr 70IU/mL
Neutral insulin, human, pyr 30IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product:
Protaphane Innolet
Active Ingredient:
Neutral insulin, human, pyr 100IU/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Dated this 10th day of February 2003.
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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Classification of Medicines
Pursuant to section 106 (1) of the Medicines Act 1981, I, G. R. Boyd, Chief Advisor, Safety and Regulation, acting under delegated authority, hereby declare the following:
-
The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
-
The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
-
The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.
Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are:
(a) preparations and admixtures containing any proportion of any substance listed in the notice.
(b) salts and esters of any substance listed in the notice.
(c) preparations or extracts of biological materials listed in the notice.
(d) salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
(i) if the medicine is an injection or eye preparation, to any concentration of that medicine; and
(ii) if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2003, No 13
Gazette.govt.nz —
NZ Gazette 2003, No 13
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare10 February 2003
Medicines Act, Consent, Distribution, New Medicines
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Classification of Medicines
π₯ Health & Social WelfareMedicines Act, Classification, Prescription Medicines, Restricted Medicines, Pharmacy-Only Medicines
- G. R. Boyd, Chief Advisor, Safety and Regulation