CVMP initiates review of withdrawal periods of certain tylosin injectable products used in pigs

  • Posted on: 30 January 2019
  • By: Shalini.Sharma

 

Committee for Medicinal Products for Veterinary Use (CVMP) adopted by consensus a positive opinion for a type II variation application (subject to a worksharing procedure) for Purevax RC, Purevax RCP, Purevax RCP FeLV, Purevax RCPCh FeLV and Purevax RCPCh concerning quality changes.

The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Versican Plus DHPPi and Versican Plus Pi. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisations. Based on pharmacovigilance grounds, the Committee concluded that a further 5-year renewal is required for both products.

The Committee started a procedure for veterinary medicinal products containing tylosin base presented as solutions for injection for intramuscular use in pigs.  The Committee agreed to include polyacrylamide hydrogel as a new entry in the list of substances considered as not falling within the scope of Regulation under the heading of substances that act by purely physical mechanisms, and adopted a revised list.

Following the Committee’s review of 5 requests for classification under the MUMS/limited market policy, the CVMP classified:
•  An immunological product for chickens as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as alternative products for the same indication are currently authorised in the EU.
•  A veterinary medicinal product (nervous system) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as according to the MUMS policy, products for horses are generally not eligible for fee incentives.
•  An immunological product for sea bass as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as alternative products for the same indication are currently authorised in the EU.
•  An immunological product for sea bass as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as alternative products for the same indication are currently authorised in the EU.
•  A veterinary medicinal product (antiparasitic products, insecticides and repellents) for rainbow trout as indicated for MUMS/limited market and therefore eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as alternative products for the same indication are currently authorised in the EU.

The Committee reviewed the PSURs for Bovela, CERTIFECT, Innovax ND IBD, Prac-Tic, Sedadex, Stronghold Plus, Suvaxyn Circo, Suvaxyn PRRS MLV, and ZULVAC SBV and concluded that no further action and no amendments to their product information were required. The Committee also reviewed the PSUR for NEXGARD SPECTRA and recommended amendments to the product information.

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