β¨ Consent to Distribution of New Medicines
NEW ZEALAND GAZETTE, No. 72 β 18 AUGUST 2016
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Cyramza
Ramucirumab 100mg/10mL
Concentrate for infusion
Eli Lilly and Company (NZ) Limited
Eli Lilly and Co Inc, Indiana, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Cyramza
Ramucirumab 500mg/50mL
Concentrate for infusion
Eli Lilly and Company (NZ) Limited
Eli Lilly and Co Inc, Indiana, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Eplerenone Te Arai
Eplerenone 25mg
Film coated tablet
Te Arai Biofarma Limited
Laboratorios Liconsa SA, Guadalajara, Spain
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Eplerenone Te Arai
Eplerenone 50mg
Film coated tablet
Te Arai Biofarma Limited
Laboratorios Liconsa SA, Guadalajara, Spain
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Ibavyr
Ribavirin 200mg
Film coated tablet
Clinect NZ Pty Limited c/o Ebos Group Limited
Pharmascience Inc, Montreal, Canada
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Nurofen for Children Soft Chews
Ibuprofen 100mg
Soft gelatin capsule
Reckitt Benckiser (New Zealand) Limited
Patheon Softgels B.V., Tilburg, Netherlands
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Sirturo
Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100mg
Tablet
Janssen-Cilag (New Zealand) Limited
Kemwell Biopharma Private Limited, Nelamangala, India
Dated this 12th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go4718
Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
HyperHep B
Hepatitis B immunoglobulin, human 220IU/mL
Solution for injection
Pharmaco (NZ) Limited
Grifols Therapeutics Inc, North Carolina, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 12th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Next Page →
β¨ LLM interpretation of page content
π₯ Consent to Distribution of New Medicines
π₯ Health & Social Welfare12 August 2016
Medicines Act 1981, New Medicines, Distribution Consent, Medsafe, Ministry of Health
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare12 August 2016
Medicines Act 1981, Provisional Consent, New Medicines, Distribution, Medsafe, Ministry of Health
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2016, No 72