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 (“Act”), that the following variation application has been made to a registered trade name product under section 9(2) of the Act:
Trade Name: Profender
Reference: A009546-13
Active Ingredients and Concentrations:
Emodepside 21.4g/L
Praziquantel 85.8g/L
Formulation Type: Oily suspension/solution
Current Claim:
For the treatment and control of internal parasites in cats including:
- Roundworms – mature, immature, and larval (L3 and L4) stages of Toxocara cati and mature, immature, larval (L4) stages of Toxascaris leonina
- Hookworm Uncinaria stenocephala*, including larval (L4) and immature stages
- Tapeworms – mature and immature stages of Dipylidium caninum, Taenia taeniaeformis.
Proposed New Claim:
For the treatment and control of internal parasites in cats including:
- Roundworms – mature, immature, and larval (L3 and L4) stages of Toxocara cati, Toxocara cati (L3 larvae)-treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring and mature, immature, larval (L4) stages of Toxascaris leonina
- Hookworm Uncinaria stenocephala*, including larval (L4) and immature stages
- Tapeworms – mature and immature stages of Dipylidium caninum, Taenia taeniaeformis
- Lungworm – Aelurostrongylus abstrusus.
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:
- must state in full the reasons for making the submission; and
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent; and
- where requests for copies of the public information relating to the application can be sent; and
- where public information relating to the application can be viewed; and
- 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 address for service is:
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.
Dated at Wellington this 5th day of September 2017.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).