β¨ Medicines Distribution Consent
NEW ZEALAND GAZETTE, No. 25 β 24 MARCH 2016
Product:
Moviprep Orange
Component 1:
Active Ingredients:
- Macrogol 3350 100g
- Potassium chloride 1.015g
- Sodium chloride 2.691g
- Sodium sulfate 7.5g
Dosage Form:
Powder for oral solution
Component 2:
Active Ingredients:
- Ascorbic acid 4.7g
- Sodium ascorbate 5.9g
Dosage Form:
Powder for oral solution
New Zealand Sponsor:
CARSL Consulting
Manufacturer:
Norgine (UK) Limited, Mid-Glamorgan, United Kingdom
Product:
Naglazyme
Active Ingredient:
Galsulfase 1mg/mL
Dosage Form:
Concentrate for infusion
New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers:
Jubilant Hollister-Stier LLC, Washington, United States of America
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Dated this 18th day of March 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go1609
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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product:
Movapo
Active Ingredient:
Apomorphine hydrochloride hemihydrate 10mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
CARSL Consulting
Manufacturer:
Hemofarm AD, Vrsac, Serbia
Product:
Tamiflu
Active Ingredient:
Oseltamivir phosphate 39.4mg equivalent to oseltamivir 30mg
Dosage Form:
Capsule
New Zealand Sponsor:
Roche Products (NZ) Limited
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
DSM Pharmaceuticals Inc, North Carolina, United States of America
Product:
Tamiflu
Active Ingredient:
Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL when reconstituted with 55mL of water
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Roche Products (NZ) Limited
Manufacturer:
Rottendorf Pharma GmbH, Ennigerloh, Germany
Product:
Tamiflu
Active Ingredient:
Oseltamivir phosphate 59.1mg equivalent to oseltamivir 45mg
Dosage Form:
Capsule
New Zealand Sponsor:
Roche Products (NZ) Limited
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
DSM Pharmaceuticals Inc, North Carolina, United States of America
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare18 March 2016
Medicines, Distribution, Consent, Medicines Act 1981, Moviprep Orange, Naglazyme
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution, Consent, Medicines Act 1981, Movapo, Tamiflu
NZ Gazette 2016, No 25