Notice Type
Departmental
Notice Title

Notice of Application to Register a Trade Name Product (Notice No. 1783)

Maree Zinzley, Manager (Approvals Operations) of the Ministry of Agriculture and Forestry (MAF) acting under delegated authority from the Director-General of MAF, 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: Tylofen
Reference: A010772
Active Ingredients and Concentrations:
Contains:
Tylosin base 200mg
Ketoprofen 60mg
Formulation Type: Injectable solution
General Use Claims:
Indicated in the treatment of systemic infections caused by bacteria sensitive to tylosin, and ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic effects.
Indicated for the treatment of infections caused by tylosin-sensitive organisms in cattle where an adjunct therapy with an NSAID is indicated.
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 of Agriculture and
Forestry, Pastoral House, Level 11, 25 The
Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Bayer NZ Limited, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.
Dated at Wellington this 22nd day of February 2012.
MAREE ZINZLEY, Manager (Approvals Operations), Ministry of Agriculture and Forestry (acting under delegated authority).