✨ Medicines Consent Notices




1632 NEW ZEALAND GAZETTE, No. 59 5 JUNE 2014

Product: Oralair (Continuation Treatment)
Active Ingredient: Grass pollen extract 300IR
Dosage Form: Sublingual tablet
New Zealand Sponsor: Ebos Group Limited
Manufacturers: Delpharm Lille SAS, Lys Lez Lannoy, France
Cenexi SAS, Osny, France

Product: Voltaren Emulgel
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany

Product: Voltaren Emulgel 12 Hourly
Active Ingredient: Diclofenac diethylamine 2.32% equivalent to Diclofenac 2%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland

Product: Voltaren Osteo
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany

Product: Xarelto
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany

Product: Xarelto
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany

Product: Xarelto
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer Healthcare Manufacturing Srl, Milan, Italy
Bayer Pharma AG, Leverkusen, Germany

Dated this 30th day of May 2014.

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

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Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Terod
Active Ingredient: Dutasteride 0.5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand

Dated this 30th day of May 2014.

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

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 59





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of Oralair and Voltaren Products

πŸ₯ Health & Social Welfare
30 May 2014
Medicines, Consent, Distribution, Oralair, Voltaren, Diclofenac, Grass pollen extract
  • Susan Martindale, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to Distribution of Xarelto Products

πŸ₯ Health & Social Welfare
30 May 2014
Medicines, Consent, Distribution, Xarelto, Rivaroxaban
  • Susan Martindale, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to Distribution of Terod

πŸ₯ Health & Social Welfare
30 May 2014
Medicines, Consent, Distribution, Terod, Dutasteride
  • Susan Martindale, Acting Group Manager, Medsafe, Ministry of Health