✨ Medicine Product Details




NEW ZEALAND GAZETTE, No. 71 β€” 11 AUGUST 2016

Product: Invega Trinza
Active Ingredient: Paliperidone palmitate 312mg/mL equivalent to palperidone 350mg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium

Product: Invega Trinza
Active Ingredient: Paliperidone palmitate 312mg/mL equivalent to palperidone 525mg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium

Product: Nausicalm (Restricted)
Active Ingredient: Cyclizine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Mapusa, India

Dated this 5th day of August 2016.

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

2016-go4569


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: Viekira Pak
Component 1:
Active Ingredients: Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Dosage Form: Film coated tablet
Manufacturer: Fournier Laboratories Ireland Limited, County Cork, Ireland
Component 2:
Active Ingredient: Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Dosage Form: Film coated tablet
Manufacturer: AbbVie Ireland NL B.V., Sligo, Ireland
New Zealand Sponsor: AbbVie Limited

Product: Viekira Pak-RBV
Component 1:
Active Ingredients: Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Dosage Form: Film coated tablet
Manufacturer: Fournier Laboratories Ireland Limited, County Cork, Ireland
Component 2:
Active Ingredient: Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Dosage Form: Film coated tablet
Manufacturer: AbbVie Ireland NL B.V., Sligo, Ireland
Component 3:
Active Ingredient: Ritonavir 200mg
Dosage Form: Film coated tablet
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
New Zealand Sponsor: AbbVie Limited

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 71





✨ LLM interpretation of page content

πŸ₯ Medicine Product Details (continued from previous page)

πŸ₯ Health & Social Welfare
5 August 2016
Medicines, Product Details, Dosage Forms, Sponsors, Manufacturers
  • SARAH READER, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Consent, Viekira Pak, Viekira Pak-RBV
  • Minister of Health