Notice Type
Departmental
Notice Title

Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI 1421)

Maree Zinzley, Manager Approvals, 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: Porcilis PCV M Hyo

Reference: A011423

Active Ingredient and Concentration:

Porcine circovirus type 2 (PCV2) ORF 2 subunit antigen Mycoplasma hyopneumoniae J strain inactivated

Formulation Type: Aqueous suspension

Current Claims:

For the active immunisation of pigs against PCV2 infection.
To reduce PCV2 associated viraemia, virus load in lungs, tonsils and lymphoid tissues.
To reduce faecal and nasal virus shedding caused by porcine circovirus type 2 (PCV2) infection, and thereby minimise environmental contamination.
To aid in the prevention of enzootic pneumonia of swine caused by Mycoplasma hyopneumoniae demonstrated by:
1. Reduction in the severity of lung lesions caused by Mycoplasma hyopneumoniae infection; and
2. Reduction of weight loss associated with infection with Mycoplasma hyopneumoniae in the finishing period.

Proposed New Claim (changes in bold):

n/a

Other Information:

Current Dosage Regime:

Administer one dose (2mL) by intramuscular injection in the neck in the area behind the ear, from 3 weeks of age.

Proposed Dosage Regime:

Administer by intramuscular injection in the neck in the area behind the ear.

Flexible Vaccination Schedule:

Option 1. Single dose (2mL): A single dose of 2mL from three weeks of age.

Option 2. Two doses (2 × 1mL): Two 1mL doses from a minimum of three days of age with an interval of at least 18 days between doses.

When PCV2 and/or M. hypopneumoniae infections occur early the two-dose vaccination schedule is recommended.

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 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:

  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 Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 15th day of December 2021.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).