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
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Prevenar 13
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
Suspension for injection
Pfizer New Zealand Limited
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
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Viekira Pak
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Film coated tablet
Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Film coated tablet
AbbVie Ireland NL B.V., Sligo, Ireland
AbbVie Limited
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Viekira Pak-RBV
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Film coated tablet
Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Film coated tablet
AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 200mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
AbbVie Limited
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Viekira Pak-RBV
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Film coated tablet
Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Film coated tablet
AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 400mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
AbbVie Limited
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Viekira Pak-RBV
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Film coated tablet
Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Film coated tablet
AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 600mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
AbbVie Limited
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Viekira Pak-RBV
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Film coated tablet
Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Film coated tablet
AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 400mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
Ribavirin 600mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
AbbVie Limited
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Dated this 21st day of August 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz