✨ Medicines Notices




NEW ZEALAND GAZETTE, No. 103

28 AUGUST 2014


Medicines Act 1981

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 set out in the Schedule hereto:

Schedule

Product: Aporyl
Active Ingredient: Amorolfine hydrochloride 5.57%w/v equivalent to Amorolfine free base 5%w/v
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Farmaclair, Saint Clair, France

Product: Humira
Active Ingredient: Adalimumab 10mg/0.2mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product: Reparo
Active Ingredient: Amorolfine hydrochloride 5.57%w/v equivalent to Amorolfine free base 5%w/v
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Farmaclair, Saint Clair, France

Product: Robitussin Cold & Chesty Cough
Active Ingredients: Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Olic (Thailand) Limited, Ayutthaya Province, Thailand
Fareva Richmond Inc, Virginia, United States of America

Product: Tivicay
Active Ingredient: Dolutegravir 50mg equivalent to Dolutegravir sodium 52.6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom

Product: Tybost
Active Ingredient: Cobicistat 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada

Dated this 22nd day of August 2014.

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

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Revocation of Consent to the Distribution of a Medicine

Pursuant to section 35(1)(c) of the Medicines Act 1981, the Minister of Health hereby revokes consent to the distribution in New Zealand of the following medicine:

Schedule

Product: Luveris
Active Ingredient: Lutropin alfa, rch 22.5mcg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Aubonne, Switzerland

Dated this 22nd day of August 2014.

STEWART JESSAMINE, 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 103





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
22 August 2014
Medicines, Distribution, Consent, Aporyl, Humira, Reparo, Robitussin Cold & Chesty Cough, Tivicay, Tybost
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Revocation of Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
22 August 2014
Medicines, Distribution, Revocation, Luveris
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health