β¨ Medicines Notices
NEW ZEALAND GAZETTE, No. 109 β 1 OCTOBER 2015
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:
Winglore
Ipilimumab 50mg/10mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Winglore
Ipilimumab 200mg/40mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Yervoy
Ipilimumab 50mg/10mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Yervoy
Ipilimumab 200mg/40mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Dated this 25th day of September 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2015-go5799
Revocation of Consent to the Distribution of Medicines
Pursuant to section 35(1)(c) of the Medicines Act 1981, the Minister of Health hereby revokes consent to the distribution in New Zealand of the following medicines:
Schedule
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Ropaccord
Ropinirole hydrochloride 0.285mg equivalent to Ropinirole 0.25mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Ropaccord
Ropinirole hydrochloride 0.57mg equivalent to Ropinirole 0.5mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Ropaccord
Ropinirole hydrochloride 1.14mg equivalent to Ropinirole 1mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Ropaccord
Ropinirole hydrochloride 2.28mg equivalent to Ropinirole 2mg
Film coated tablet
Accord Healthcare NZ Limited
Intas Pharmaceuticals Limited, Gujarat, India
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π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare25 September 2015
Medicines, Distribution, Winglore, Yervoy, Ipilimumab, Bristol-Myers Squibb, Baxter Pharmaceutical Solutions
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Revocation of Consent to the Distribution of Medicines
π₯ Health & Social WelfareMedicines, Revocation, Ropaccord, Ropinirole, Accord Healthcare, Intas Pharmaceuticals
NZ Gazette 2015, No 109