New Medicine Consents




NEW ZEALAND GAZETTE, No. 44

18 APRIL 2013

Product:
INLYTA

  • Active Ingredient: Axitinib 5mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Pfizer New Zealand Limited
  • Manufacturer: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Product:
Lemsip Max Sinus + Pain Relief Hot Drink

  • Active Ingredients:
    • Paracetamol 1000mg
    • Phenylephrine hydrochloride 12.2mg equivalent to Phenylephrine 10mg
  • Dosage Form: Powder for oral solution
  • New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
  • Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom

Product:
Lemsip Sinus + Pain Relief Capsules

  • Active Ingredients:
    • Paracetamol 500mg
    • Phenylephrine hydrochloride 6.1mg equivalent to Phenylephrine 5mg
  • Dosage Form: Powder filled capsule
  • New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
  • Manufacturers:
    • Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
    • Perrigo UK Limited, Devon, United Kingdom

Product:
Nasal Decongestant

  • Active Ingredient: Phenylephrine hydrochloride 10mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Multichem NZ Limited
  • Manufacturer: Cipla Limited, Maharashtra, India

Product:
Onyban Nail-Aid

  • Active Ingredient: Amorolfine hydrochloride 6.4% w/w equivalent to Amorolfine 5% w/w
  • Dosage Form: Nail lacquer
  • New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
  • Manufacturer: Chanelle Medical Limited, County Galway, Ireland

Product:
VitA-POS

  • Active Ingredient: Retinol palmitate 0.138mg/g equivalent to Vitamin A 250 IU/g
  • Dosage Form: Eye ointment
  • New Zealand Sponsor: AFT Pharmaceuticals Limited
  • Manufacturer: Ursapharm Arzneimittel GmbH, Saarbrücken, Germany

Product:
Yasmin Plus

  • Active Tablet:
    • Active Ingredients:
      • Drospirenone 3mg
      • Ethinylestradiol 30mcg
      • Levomefolate calcium 451mcg equivalent to Folic acid 400mcg
    • Dosage Form: Tablet
  • Placebo Tablet:
    • Active Ingredient: Levomefolate calcium 451mcg equivalent to Folic acid 400mcg
    • Dosage Form: Tablet
  • New Zealand Sponsor: Bayer New Zealand Limited
  • Manufacturer: Bayer Weimar GmbH und Co KG, Weimar, Germany

Product:
Your Pharmacy Loratadine Tablets

  • Active Ingredient: Loratadine 9.999mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Orion Laboratories (NZ) Limited
  • Manufacturer: L Perrigo Company, Michigan, United States of America

Dated this 10th day of April 2013.

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).

go2210

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:



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 44





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
10 April 2013
Medicines Act 1981, New Medicines, Consent, Distribution
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health