Extract from the measure # 65 of February 2, 2015 immunological veterinary medicinal product DURAMUNE PUPPY DP + C (AIC # 103754)-For all packs A.I.C. Holder: ZOETIS ITALIA S.R. L, Via Andrea Doria, 41 M-00192 Roma (RM) Object of the measure: worksharing procedure: UK/V/xxxx/WS/022 Grouping of type II variations.
You authorize the change as described below:-type II. N. b. II. d. 1 e). Change in the specification parameters and/or limits of the finished product, review that is outside the bounds of the approved specification.
You authorize the amendment of infectious title for the values contained in the powder fraction of the vaccine. The new limits are: Canine distemper Virus strain from 101.1 to 103.4 Onderstepoort TCID50 */dose canine Parvovirus strain SAH from 104.7 to 106.5 TCID50 */dose * TCID50 = 50% tissue culture infectious dose the batches of vaccine already on the market, may be marketed until their expiry date.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.