✨ Medicines Approval Notices




NEW ZEALAND GAZETTE, No. 147

29 SEPTEMBER 2011

Product: Apo-Ropinirole

  • Active Ingredient: Ropinirole hydrochloride 3.42mg equivalent to 3mg ropinirole
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Apotex NZ Limited
  • Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Ropinirole

  • Active Ingredient: Ropinirole hydrochloride 4.56mg equivalent to 4mg ropinirole
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Apotex NZ Limited
  • Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Ropinirole

  • Active Ingredient: Ropinirole hydrochloride 5.7mg equivalent to 5mg ropinirole
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Apotex NZ Limited
  • Manufacturer: Apotex Inc, Ontario, Canada

Product: Bosvate

  • Active Ingredient: Bisoprolol fumarate 2.5mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Douglas Pharmaceuticals Limited
  • Manufacturer: Chanelle Medical Limited, County Galway, Ireland

Product: Bosvate

  • Active Ingredient: Bisoprolol fumarate 5mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Douglas Pharmaceuticals Limited
  • Manufacturer: Chanelle Medical Limited, County Galway, Ireland

Product: Bosvate

  • Active Ingredient: Bisoprolol fumarate 10mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Douglas Pharmaceuticals Limited
  • Manufacturer: Chanelle Medical Limited, County Galway, Ireland

Product: Canesten Plus

  • Active Ingredients:
    • Clotrimazole 10mg/g
    • Hydrocortisone acetate 11.2mg/g equivalent to hydrocortisone 10mg
  • Dosage Form: Topical cream
  • New Zealand Sponsor: Bayer New Zealand Limited
  • Manufacturer: Kern Pharma SL, Barcelona, Spain

Product: Lamisil Spray

  • Active Ingredient: Terbinafine hydrochloride 10mg/mL
  • Dosage Form: Topical spray
  • New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
  • Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland

Product: MMF-Panacea Biotec

  • Active Ingredient: Mycophenolate mofetil 250mg
  • Dosage Form: Capsule
  • New Zealand Sponsor: Pharmaco (NZ) Limited
  • Manufacturer: Panacea Biotec Limited, Solan Himachal Pradesh, India

Product: Motetis

  • Active Ingredient: Tetrabenazine 25mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Douglas Pharmaceuticals Limited
  • Manufacturer: Trommsdorff GmbH & Co. KG Arzneimittel, Alsdorf, Germany

Dated this 26th day of September 2011.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 147





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
26 September 2011
Medicines, Approval, Distribution, Apo-Ropinirole, Bosvate, Canesten Plus, Lamisil Spray, MMF-Panacea Biotec, Motetis
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health