✨ Medicinal Product Notices




2124

NEW ZEALAND GAZETTE, No. 82

19 JULY 2007

Product:
Rotarix
Active Ingredient:
Rotavirus vaccine 1,000,000CCID50
Dosage Form:
Powder for oral suspension
Diluent

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 16th day of July 2007.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go4949

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Apo-Alendronate
Active Ingredient:
Alendronate sodium trihydrate 91.35mg equivalent to 70mg alendronate
Dosage Form:
Tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Inc, Weston, Ontario, Canada

Product:
Apo-Megestrol
Active Ingredient:
Megestrol acetate 160mg
Dosage Form:
Tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Inc, Weston, Ontario, Canada

Product:
Apo-Megestrol
Active Ingredient:
Megestrol acetate 40mg
Dosage Form:
Tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturer:
Apotex Inc, Weston, Ontario, Canada

Product:
m-Aciclovir
Active Ingredient:
Aciclovir 250mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Reig Jofre SA, Sant Joan Despi, Barcelona, Spain

Product:
Nausicalm
Active Ingredient:
Cyclizine lactate 50mg
Dosage Form:
Solution for injection
New Zealand Sponsor:
AFT Pharmaceuticals Limited
Manufacturer:
Cenexi SAS, Fontenay-sous-Bois, France

Product:
Oliclinomel N4-550
Active Ingredients:
Alanine 11.39g/L
Arginine 6.33g/L
Glycine 5.67g/L
Histidine 2.64g/L
Isoleucine 3.3g/L
Leucine 4.02g/L
Lysine hydrochloride 3.99g/L equivalent to lysine 3.19g/L
Methionine 2.2g/L
Phenylalanine 3.08g/L
Proline 3.74g/L
Serine 2.75g/L
Threonine 2.31g/L
Tryptophan 0.99g/L
Tyrosine 0.22g/L
Valine 3.19g/L
Glucose monohydrate 220g/L equivalent to glucose 200g/L
Olive oil 80g/L
Soya oil 20g/L



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 82


Gazette.govt.nz PDF NZ Gazette 2007, No 82





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Rotarix Vaccine

πŸ₯ Health & Social Welfare
16 July 2007
Rotavirus vaccine, Medicines Act 1981, GlaxoSmithKline
  • ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, Alendronate, Megestrol, Aciclovir, Cyclizine, Nutrition