Glen Bradbury, Manager, (ACVM Appraisal and Programmes), ACVM Group 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 a decision has been made under section 29(1) of the Act 1997, to reassess the following registered trade name products:
Trade Name: Selovin LA
Reference: A009509
Active Ingredient and Concentration:
Barium selenate 177.48g/L
Formulation Type: Aqueous suspension (emulsion)
General Use Claims:
This formulation produces a rise in the selenium status of sheep and cattle, reaching increased levels in the body in approximately 3-4 weeks and lasting up to twelve months. The treatment of animals in early to mid-pregnancy provides selenium for the newborn.
Trade Name: Deposel Multidose
Reference: A004546
Active Ingredient and Concentration:
Barium selenate 175.0g/L
Formulation Type: Aqueous suspension
General Use Claim: For the prevention and treatment of selenium deficiency in cattle and sheep.
Reason for Reassessments: The decision to reassess has been determined based on the submission of a large number of serious Adverse Event Reports involving the use of this product, and new information regarding the concurrent use of long-acting barium selenate injectable products and Bovine Viral Diarrhoea (BVD) vaccines in cattle.
Any person may make a written submission to the
director-general concerning any of these reassessments.
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 the reassessment; and
(c) must be received by the director-general no later than 30 working days after the date of notification in this New Zealand Gazette.
A copy of every submission will be forwarded to the applicant for its information.
The following address is:
(a) where submissions on these reassessments are to be sent; and
(b) where requests for copies of the public information relating to these reassessments can be sent; and
(c) where public information relating to these reassessments 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.
Dated at Wellington this 2nd day of September 2011.
GLEN BRADBURY, Manager (ACVM Appraisals and Programmes), Ministry of Agriculture and Forestry (acting under delegated authority).