✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 25





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
18 March 2016
Medicines, Distribution, Consent, Medicines Act 1981, Moviprep Orange, Naglazyme
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Consent, Medicines Act 1981, Movapo, Tamiflu