β¨ 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
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2007, No 82
Gazette.govt.nz —
NZ Gazette 2007, No 82
β¨ LLM interpretation of page content
π₯ Consent to Distribution of Rotarix Vaccine
π₯ Health & Social Welfare16 July 2007
Rotavirus vaccine, Medicines Act 1981, GlaxoSmithKline
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent to Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act 1981, Alendronate, Megestrol, Aciclovir, Cyclizine, Nutrition