✨ Medicine Product Notices




NEW ZEALAND GAZETTE, No. 99 β€” 3 NOVEMBER 2016

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

Levetiracetam
Levetiracetam 1000mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Otezla
Apremilast 30mg
Film coated tablet
Celgene Limited
Celgene International Sarl, Boudry, Switzerland
Patheon Inc, Whitby Operations, Whitby, Canada
Patheon Inc, Toronto Region Operations (TRO), Mississauga, Canada

Product:
Component 1:
Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
Component 3:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Otezla
Apremilast 10mg
Film coated tablet
Apremilast 20mg
Film coated tablet
Apremilast 30mg
Film coated tablet
Celgene Limited
Celgene International Sarl, Boudry, Switzerland
Patheon Inc, Whitby Operations, Whitby, Canada
Patheon Inc, Toronto Region Operations (TRO), Mississauga, Canada

Dated this 27th day of October 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2016-go6171

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:

Fungilin
Amphotericin B 10mg
Lozenge
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Aspen Pharma Pty Limited, Melbourne, Australia

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

Humira
Adalimumab 10mg/0.2mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Humira
Adalimumab 20mg/0.4mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg,
49



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 99





✨ LLM interpretation of page content

πŸ₯ Product Listing for Levetiracetam 1000mg (continued from previous page)

πŸ₯ Health & Social Welfare
27 October 2016
Medicine, Levetiracetam, PSM Healthcare, Hetero Labs
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Product Listing for Otezla (Apremilast)

πŸ₯ Health & Social Welfare
27 October 2016
Medicine, Otezla, Apremilast, Celgene Limited, Celgene International Sarl, Patheon Inc
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
27 October 2016
Medicine, Fungilin, Amphotericin B, Pharmacy Retailing (NZ) Limited, Aspen Pharma Pty Limited
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of Humira (Adalimumab) 10mg/0.2mL

πŸ₯ Health & Social Welfare
27 October 2016
Medicine, Humira, Adalimumab, AbbVie Limited, Vetter Pharma-Fertigung GmbH & Co KG
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of Humira (Adalimumab) 20mg/0.4mL

πŸ₯ Health & Social Welfare
27 October 2016
Medicine, Humira, Adalimumab, AbbVie Limited, Vetter Pharma-Fertigung GmbH & Co KG
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health