Pursuant to section 14 (1) of the Agricultural Compounds and Veterinary Medicines Act 1997, the Director-General of the Ministry of Agriculture and Forestry hereby gives notice that the following application has been made to register trade name products under section 9 (1) of the Agricultural Compounds and Veterinary Medicines Act 1997:
Trade Name: Prilium 150 MG
Reference: A009527
Active Ingredients and Concentrations: Imidapril HCL 170 g/kg as freeze dried powder or 5 g/L reconstituted solution
General Use Claim: In dogs and cats: Treatment of heart failure of stages II, III and IV according to the NYHA classification, caused by mitral regurgitation or by dilated cardiomyopathy.
Trade Name: Prilium 300 MG
Reference: A009528
Active Ingredients and Concentrations: Imidapril HCL 300 g/kg as freeze dried powder or 10 g/L reconstituted solution
General Use Claim: In dogs and cats: Treatment of heart failure of stages II, III and IV according to the NYHA classification, caused by mitral regurgitation or by dilated cardiomyopathy.
Trade Name: Prilium 75 MG
Reference: A009529
Active Ingredients and Concentrations: Imidapril HCL 300 g/kg as freeze dried powder or 10 g/L reconstituted solution
General Use Claim: In dogs and cats: Treatment of heart failure of stages II, III and IV according to the NYHA classification, caused by mitral regurgitation or by dilated cardiomyopathy.
Any person may make a written submission to the Director-General, under section 17 of the Agricultural Compounds and Veterinary Medicines Act 1997, concerning any application notified above.
Such submissions:
(a) must state in full the reasons for making the submission;
(b) may state any decision sought on that application;
(c) must be received by the Director-General no later than 30 working days after the date of notification in the
New Zealand Gazette; and
(d) should be forwarded to the address given below.
A copy of every submission will be forwarded to the applicant for their information.
The address below is:
(a) where submissions and requests for copies of the public information relating to the application can be sent;
(b) where the public information relating to the application can be viewed; and
(c) the Director-General’s address for service:
ACVM Group, New Zealand Food Safety Authority, Ministry of Agriculture and Forestry, 68-86 Jervois Quay
(P.O. Box 2835), Wellington.
The applicant’s address for service is:
Ethical Agents Limited, 54 Hobill Avenue, Wiri, South Auckland.
Dated at Wellington this 22nd day of April 2005.
MAREE ZINZLEY, Programme Manager (Operations) (acting under delegated authority).