✨ Medicines Notices




NEW ZEALAND GAZETTE, No. 75 β€” 25 AUGUST 2016

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 30mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 40mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 60mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Controlled Release Actavis
Oxycodone hydrochloride 80mg
Modified release tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Dated this 18th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go4810

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Flebogamma 5% DIF
Normal immunoglobulin 50g/L
Solution for infusion
Medi’Ray New Zealand Limited
Instituto Grifols S.A, Barcelona, Spain

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Schering-Plough Company, County Cork, Ireland

Dated this 18th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go4811

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renew the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 75





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
18 August 2016
Medicines, Distribution, Oxycodone, Actavis, Modified Release Tablet
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
18 August 2016
Medicines, Distribution, Flebogamma, Keytruda, Solution for Infusion, Powder for Infusion
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
Medicines, Renewal, Provisional Consent