✨ Consent to Distribution of New Medicines
NEW ZEALAND GAZETTE, No. 102 — 5 OCTOBER 2017
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Abstral
Fentanyl citrate 471.3mcg equivalent to fentanyl 300mcg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Aesica Queenborough Limited, Queenborough, United Kingdom
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Abstral
Fentanyl citrate 628.4mcg equivalent to fentanyl 400mcg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Aesica Queenborough Limited, Queenborough, United Kingdom
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Abstral
Fentanyl citrate 942.6mcg equivalent to fentanyl 600mcg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Aesica Queenborough Limited, Queenborough, United Kingdom
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Abstral
Fentanyl citrate 1257mcg equivalent to fentanyl 800mcg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Aesica Queenborough Limited, Queenborough, United Kingdom
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Tagrisso
Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg
Film coated tablet
AstraZeneca Limited
AstraZeneca AB, Södertälje, Sweden
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Tagrisso
Osimertinib mesilate 95.4mg equivalent to osimertinib 80mg
Film coated tablet
AstraZeneca Limited
AstraZeneca AB, Södertälje, Sweden
Dated this 29th day of September 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).
2017-go5148
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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH, Innishannon, Ireland
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
Soliris
Eculizumab 300mg
Solution for infusion
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Patheon Manufacturing Services, North Carolina, United States of America
Patheon Italia SpA, Milan, Italy
Patheon Italia SpA, Frosinone, Italy
Dated this 29th day of September 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health).
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✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare29 September 2017
Medicines Act 1981, Abstral, Fentanyl citrate, Pharmacy Retailing (NZ) Limited, Aesica Queenborough Limited, Tagrisso, Osimertinib mesilate, AstraZeneca Limited, AstraZeneca AB
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
🏥 Consent to the Distribution of New Medicines
🏥 Health & Social Welfare29 September 2017
Medicines Act 1981, Keytruda, Pembrolizumab, Merck Sharp & Dohme (New Zealand) Limited, MSD International GmbH, Soliris, Eculizumab, Pharmacy Retailing (NZ) Limited, Patheon Manufacturing Services, Patheon Italia SpA
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
NZ Gazette 2017, No 102