β¨ 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
64
Next Page →
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare21 August 2017
Medicines, Distribution, Consent, Medicines Act 1981
π₯ Approval of Prevenar 13 for Distribution
π₯ Health & Social WelfareMedicine, Vaccine, Pneumococcal, Approval
π₯ Approval of Viekira Pak for Distribution
π₯ Health & Social WelfareMedicine, Treatment, Hepatitis C, Approval
π₯ Approval of Viekira Pak-RBV for Distribution
π₯ Health & Social WelfareMedicine, Treatment, Hepatitis C, Ribavirin, Approval
NZ Gazette 2017, No 86