Notice Type
Departmental
Notice Title

Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI ACVM 82)

Publication Date
29 May 2025

Tags

Agricultural Compounds and Veterinary Medicines Act Application to vary conditions of a registered trade name product Primary Industries

Notice Number

2025-go2913
Title
View PDF
File Type and Size
PDF (31 KB)

Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:

Trade Name

Registration Number

Active ingredient(s) and its concentration(s):

Metacam 40mg/mL solution for injection

A011754

Meloxicam 40mg/mL

Metacam 20mg/mL solution for injection

A007982

Meloxicam 20mg/mL

Formulation type: Aqueous solution

Application method/administration route: Parenteral Injection

Existing use claim:

A011754 – A non-steroidal anti-inflammatory, analgesic and antipyretic for use in cattle and horses.

A007982 – A non-steroidal anti-inflammatory, analgesic and antipyretic for use in cattle, sheep, pigs and horses.

A011754 and A007982

Cattle: For the alleviation of pain and inflammation associated with surgery. For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral-rehydration therapy to reduce clinical signs in calves and young cattle. For use in acute mastitis, in combination with appropriate antibiotic therapy in lactating cows.

For use to assist in the control of pain following the dehorning of cattle, particularly that following heat cautery dehorning of young cattle. It is recommended that the injection be administered approximately 10 minutes before dehorning and be accompanied by a cornual nerve block anaesthesia.

Proposed new claims (changes in bold):

A011754 and A007982

Cattle: For the alleviation of pain and inflammation associated with surgery. For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral-rehydration therapy to reduce clinical signs in calves and young cattle. For use in acute mastitis, in combination with appropriate antibiotic therapy in lactating cows.

For use to assist in the control of pain following the dehorning of cattle, particularly that following heat cautery dehorning of young cattle. It is recommended that the injection be administered approximately 10 minutes before dehorning and be accompanied by a cornual nerve block anaesthesia.

The inflammation associated with mastitis or lameness has been shown to negatively impact reproduction in cattle, resulting in increased non-discretionary culling. Countering the inflammation with METACAM can significantly improve reproductive outcomes when treating mastitis and lameness cases.

In both NZ based and overseas studies with dairy cows, those given METACAM alongside routine antibiotic therapy for mastitis, or claw horn lameness alongside hoof trim and block, showed the following outcomes:

  1. The addition of METACAM to the treatment protocol for cows with mastitis significantly improved overall first service conception rate, six-week in calf rate and final pregnancy rate with reduced involuntary culling for reproductive outcomes compared to the use of antibiotic treatment alone.
  2. The addition of METACAM to the treatment protocol for cows with claw horn lameness significantly improved six-week in calf rate and final pregnancy rate compared to trimming and application of blocks alone.
  3. The addition of METACAM to the treatment protocol for cows with Mastitis improved milk quality by reducing somatic cell counts and improving bacteriological cure rates compared to antibiotic treatment alone.
  4. The long-acting analgesic and anti-inflammatory effects (up to 72 hours) of METACAM are used to optimise treatment outcomes and support a faster, more comfortable journey to recovery.


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:

  1. must state in full the reasons for making the submission;
  2. may state any decision sought on that application; and
  3. must be received by the Director-General no later than 30 working days after the date of this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

The following address is:

  1. where submissions on this application are to be sent;
  2. where requests for copies of the public information relating to the application can be sent;
  3. where public information relating to the application can be viewed; and
  4. the Director-General’s address for service:

ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 2, 3 Te Kehu Way, Mount Wellington, Auckland 1060. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 28th day of May 2025.

SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).