Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 ("the Act"), that the following application has been made to register a trade name product under section 9(1) of the Act:
Trade Name: Zolvix Plus Broad Spectrum Oral Anthelmintic for Sheep
Reference: A011107
Active Ingredients and Concentrations:
Monepantel 25mg/mL
Abamectin 2mg/mL
Formulation Type: Liquid
General Use Claim:
ZOLVIX© PLUS is effective for the treatment and control of sensitive strains of nematodes (roundworms), lungworm, nasal bots and itch mite, including nematodes that have single, dual or
triple resistance to macrocyclic lactones (including moxidectin resistant strains), benzimidazoles
(white drenches), imidazothiazoles (levamisole and morantel (clear drenches)) and salicylanilide
(e.g. closantel)-resistant strains. ZOLVIX© PLUS is also effective against AAD-sensitive immature (L4) stages of Haemonchus contortus and Teladorsagia circumcincta where a combination of a macrocyclic lactone and derquantel is less effective.
Any person may make a written submission to the
director-general concerning this application.
Under sections 16 and 17 of the Act, a written submission:
(a) must state in full the reasons for making the submission; and
(b) may state any decision sought on that application; and
(c) must be received by the director-general no later than 30 working days after the date of notification
in the New Zealand Gazette.
Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant's information.
The following address is:
(a) where submissions on this application are to be sent; and
(b) where requests for copies of the public information relating to the application can be sent; and
(c) where public information relating to the application can be viewed; and
(d) the director-general's address for service:
ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant's addresses for service are:
Novartis New Zealand Limited, Building G, Orbit Drive, Rosedale, Auckland 0632, or 54 Waterloo Road,
North Ryde, New South Wales 2113, Australia.
Dated at Wellington this 19th day of August 2014.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).