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 reasses the following trade name products under section 9(1) of the Act:
Trade Name Reference Active Ingredient(s) and Concentration(s) Formulation Type Affected Use Claims
Avatec/Bovatec Technical A010829 Lasalocid Sodium 900g/kg
Granular Powder Control of coccidiosis caused by Eimeria species in goats and cattle; Improvement in weight gain in goats and cattle; Increased production of milk solids (milk fat and milk protein) in dairy cows; control of ketosis in dairy cattle with subsequent improvement in immune function, which can aid
in reducing the incidence of clinical mastitis in lactating dairy cows; Reduction in bloat score in cattle on pasture.
Bio-Cox 120G
A008279 Salinomycin Sodium 120g/kg Powder For enhancing productivity by increasing the rate of weight gain and improving feed efficiency of grower/finisher pigs and feedlot beef cattle.
Bovatec
A004395 Lasalocid Sodium 150g/kg Powder Control of coccidiosis caused by Eimeria species in goats and cattle; Improvement in weight gain in goats and cattle; Increased production of milk solids (milk fat and milk protein) in dairy cows; control of ketosis in dairy cattle with subsequent improvement in immune function, which can aid
in reducing the incidence of clinical mastitis in lactating dairy cows; Reduction in bloat score in cattle on pasture.
Bovatec 20 Liquid A006956 Lasalocid Sodium 208g/L Aqueous Liquid (Solution or Suspension) Control of coccidiosis caused by Eimeria species in goats and cattle; Improvement in weight gain in goats and cattle; Increased production of milk solids (milk fat and milk protein) in dairy cows; control of ketosis in dairy cattle with subsequent improvement in immune function, which can aid
in reducing the incidence of clinical mastitis in lactating dairy cows; Reduction in bloat score in cattle on pasture.
Bovatec 20CC A009679 Lasalocid Sodium 200g/kg Powder Control of coccidiosis caused by Eimeria species in goats and cattle; Improvement in weight gain in goats and cattle; Increased production of milk solids (milk fat and milk protein) in dairy cows; control of ketosis in dairy cattle with subsequent improvement in immune function, which can aid
in reducing the incidence of clinical mastitis in lactating dairy cows; Reduction in bloat score in cattle on pasture.
Coxidin 200
A010328 Monensin Sodium 200g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Coxidin 400
A010329 Monensin Sodium 400g/kg Powder Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Coxistac 120G Anticoccidial Premix Feed Additive Premix Oral A009595 Salinomycin Sodium 120g/kg
Powder Affected Use Claim: For enhancing productivity by increasing the rate of weight gain and improving feed efficiency of grower/finisher pigs and feedlot beef cattle.
Donaghys ProMonensin 60
A010904 Monensin Sodium 60g/L Aqueous Suspension For increased production of milk solids in pasture fed dairy cows; As an aid in the control of ketosis in cattle; As an aid in the reduction of bloat.
Elancoban 200
A007100 Monensin Sodium 200g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain;
As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Kexxtone
A010836 Monensin Sodium
32g per capsule Bolus As an aid in the reduction of bloat in beef and dairy cattle; For increased feed efficiency and/or weight gain in beef cattle; For increased production of milk solids in pasture fed dairy cows; As an aid in the control of ketosis in dairy and beef cows
Moneco 200 Granular A009232 Monensin Sodium 200g/kg
Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Monensin Granulated A009245 Monensin Sodium 200g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Monotec 100 MicroGranule Premix
A010036 Monensin Sodium 100g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii; As an aid in the reduction of bloat.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Monotec 200 MicroGranule Premix
A010771 Monensin Sodium 200g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
PhibroMonensin 100 Custom Premix Feed Additive A009892 Monensin Sodium 100g/kg
Powder Feedlot cattle: Improved feed efficiency
Feedlot Cattle and Dairy Cows: As an aid in the control of bloat
Dairy Cattle: To increase milk production in dairy cows under many conditions; As an aid in reducing the severity of non-clinical ketosis in lactating dairy cows.
Cattle: To aid in the prevention of coccidiosis in cattle 50kg to 150kg liveweight.
PhibroMonensin 200 Custom Premix
A009653 Monensin Sodium 200g/kg Powder Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis in lactating dairy cows; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain.
PhibroMonensin 400 A009493 Monensin Sodium 400g/kg Powder Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis in lactating dairy cows; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain.
ProMonensin Premix 20 A010934 Monensin Sodium 200g/kg Powder For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Reward Mini Dose
A010864 Monensin Sodium 120g/L Aqueous Suspension As an aid in the control of ketosis in cattle; As an aid in the reduction of bloat.
Rumenox
A010896 Monensin Sodium 300g/kg Granule As an aid in the control of ketosis in cattle; As an aid in the reduction of bloat.
Rumensin 20% Millmix A009107 Monensin Sodium 200g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii; As an aid in the reduction of bloat.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii; As an aid in the reduction of bloat.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Rumensin Capsule
A009676 Monensin Sodium
32g per capsule Bolus As an aid in the reduction of bloat in beef and dairy cattle; For increased feed efficiency and/or weight gain in beef cattle; For increased production of milk solids in pasture fed dairy cows; As an aid in the control of ketosis in dairy and beef cows
Rumensin Max A010731 Monensin Sodium 150g/L
Aqueous Suspension For increased milk protein in pasture fed dairy cows; As an aid in the control of ketosis in cattle; As an aid in the reduction of bloat.
Rumensin Premix
A003553 Monensin Sodium 100g/kg Granule Dairy Cattle: For increased milk protein production; As an aid in the control of ketosis; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Beef Cattle: For improved feed efficiency and/or rate of weight gain; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii; As an aid in the reduction of bloat.
Beef Cows: For improved feed efficiency as indicated by improvement in the relationship of feed to cow weight, calf weight, and reproductive performance.
Replacement heifers: For increased rate of weight gain and to promote earlier onset of first oestrous; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii.
Rumensin Select A007450 Monensin Sodium 60g/L Aqueous Suspension As an aid in the reduction of bloat in pasture fed dairy cattle; For increased production of milk solids in pasture fed dairy cows; As an aid in the control of ketosis in cattle.
Rumensin Technical
A007871 Monensin Sodium 1000g/kg Granule As an aid in the control of ketosis in dairy cattle; For increased milk protein production in dairy cattle; As an aid in the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii; For improved feed efficiency and/or rate of weight gain in beef cattle; As an aid in the reduction of bloat.
Rumensin Trough Treatment A008278 Monensin Sodium 60.00g/L Aqueous Suspension For increased production of milk solids in pasture fed dairy cows; As an aid in the control of ketosis in cattle; As an aid in the reduction of bloat.
Sacox 120
A007640 Salinomycin Sodium 120g/kg Granule For enhancing productivity by increasing the rate of weight gain and improving feed efficiency of grower/finisher pigs and feedlot beef cattle.
Reason for Reassessment: The policy surrounding the use of ionophore-based products in cattle for the purposes of growth promotion has been changed in the European Union (EU). As a result, MPI-approved label claims including those associated with growth promotion now require reassessment. In addition, there have also been changes to the EU Maximum Residue Limits (MRLs) set for the use of ionophore-based products in cattle. These MRL changes require a review of the currently approved withholding periods for ionophore-based products to ensure the use of these products will still comply with EU requirements for food exported to their market. This reassessment will only apply to those products used in cattle; products used exclusively in poultry and/or pigs have been excluded.
MPI considers the changes in the EU policy significant new information on a matter related to the use of the veterinary medicines containing ionophores for use in cattle (section 29(1)(a) of the Agricultural Compounds and Veterinary Medicines Act 1997).
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 address for service is:
Merial New Zealand Limited, Level 3, Merial Building, 2 Osterley Way, Manukau, Auckland 2104. Postal Address:
PO Box 76211, Manukau City, Auckland 2241.
Dated at Wellington this 12th day of May 2014.
MAREE ZINZLEY, Manager (Approvals Operations), Ministry for Primary Industries (acting under delegated authority).