✨ 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).



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 72





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
12 August 2016
Medicines Act 1981, New Medicines, Distribution Consent, Medsafe, Ministry of Health
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
12 August 2016
Medicines Act 1981, Provisional Consent, New Medicines, Distribution, Medsafe, Ministry of Health
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health