✨ Medicines Approval Notices




NEW ZEALAND GAZETTE, No. 86 β€” 24 AUGUST 2017

Product:
Prevenar 13

Active Ingredients:

  • Pneumococcal polysaccharide serotype 6A 2.2mcg
  • Pneumococcal polysaccharide type 1 2.2mcg
  • Pneumococcal polysaccharide type 14 2.2mcg
  • Pneumococcal polysaccharide type 18C 2.2mcg
  • Pneumococcal polysaccharide type 19A 2.2mcg
  • Pneumococcal polysaccharide type 19F 2.2mcg
  • Pneumococcal polysaccharide type 23F 2.2mcg
  • Pneumococcal polysaccharide type 3 2.2mcg
  • Pneumococcal polysaccharide type 4 2.2mcg
  • Pneumococcal polysaccharide type 5 2.2mcg
  • Pneumococcal polysaccharide type 6B 4.4mcg
  • Pneumococcal polysaccharide type 7F 2.2mcg
  • Pneumococcal polysaccharide type 9V 2.2mcg

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturers:

  • Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, New York, United States of America
  • Baxter BioPharma Solutions LLC, Indiana, United States of America
  • Pfizer Ireland Pharmaceuticals, Dublin, Ireland

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:

  • Ribavirin 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 2017, No 86





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
21 August 2017
Medicines, Distribution, Consent, Medicines Act 1981

πŸ₯ Approval of Prevenar 13 for Distribution

πŸ₯ Health & Social Welfare
Medicine, Vaccine, Pneumococcal, Approval

πŸ₯ Approval of Viekira Pak for Distribution

πŸ₯ Health & Social Welfare
Medicine, Treatment, Hepatitis C, Approval

πŸ₯ Approval of Viekira Pak-RBV for Distribution

πŸ₯ Health & Social Welfare
Medicine, Treatment, Hepatitis C, Ribavirin, Approval