Medicine Approval Notices




3230

NEW ZEALAND GAZETTE, No. 113

13 SEPTEMBER 2012

Product: Hayfever Relief
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India

Product: Kopigra
Active Ingredient: Sildenafil citrate 35.12mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Kopigra
Active Ingredient: Sildenafil citrate 70.24mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Kopigra
Active Ingredient: Sildenafil citrate 140.48mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Rovost
Active Ingredient: Sildenafil citrate 28.096mg equivalent to sildenafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Product: Scytera
Active Ingredient: Coal tar solution 10%w/w equivalent to coal tar 2%w/w
Dosage Form: Foam
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: DPT Laboratories Limited, Texas, United States of America

Product: Xyntha
Active Ingredient: Moroctocog alfa 3000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Dated this 6th day of September 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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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: Cyklokapron
Active Ingredient: Tranexamic acid 500mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia SrL, Ascoli Piceno, Italy

Product: Cyklokapron
Active Ingredient: Tranexamic acid 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 113





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
6 September 2012
Medicine Approval, Cetirizine, Sildenafil, Coal Tar, Moroctocog Alfa, Medicines Act 1981
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicine Approval, Tranexamic Acid, Medicines Act 1981