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 set out in the Schedule hereto:
Schedule
Product: Apo-Amiloride
Active Ingredient: Amiloride hydrochloride dihydrate 5.7mg equivalent to amiloride hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 227.6mg equivalent to gemcitabine 200mg
Dosage Form: Powder for infusion
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 1138mg equivalent to gemcitabine 1g
Dosage Form: Powder for infusion
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Dated this 3rd day of October 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).