Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Valaciclovir Actavis 1000
Active Ingredient: Valaciclovir hydrochloride monohydrate 1223.4mg equivalent to Valaciclovir base 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Product: Valaciclovir Actavis 250
Active Ingredient: Valaciclovir hydrochloride monohydrate 305.85mg equivalent to Valaciclovir base 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Product: Valaciclovir Actavis 500
Active Ingredient: Valaciclovir hydrochloride monohydrate 611.7mg equivalent to Valaciclovir base 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Dated this 8th day of July 2013.
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).