Extract from the measure # 35 of veterinary medicinal product: SOFTIFLOX January 19, 2015 5 mg flavoured chewable tablets for cats and dogs SOFTIFLOX 20 mg chewable flavored SOFTIFLOX flavored dog 80 mg chewable tablets for dogs (A.I.C. nn. 104473).
A.I.C. holder: Norbrook Laboratories Ltd, Station Works Newry County Down Northern Ireland BT35 6JP.
The object of the measure: European Procedure Number: IE/V/0298/IB/002/G.
You authorize the extension of the period of validity of the medicinal product as packaged for sale from 18 months to 2 years.
The variation on the extension of the period of validity of the medicine changes the point 6.3 of the SPC as follows: «Softiflox» 5 mg flavoured chewable tablets for cats and dogs 6.3 validity period of validity of the veterinary medicinal product as packaged for sale: 2 years.
«Softiflox» 20 mg chewable tablets dog flavoured 6.3 validity period of validity of the veterinary medicinal product as packaged for sale: 2 years.
«Softiflox» 80 mg chewable dog flavoured 6.3 validity period of validity of the veterinary medicinal product as packaged for sale: 2 years.
Do not use uniforms, tablets can be stored for 24 hours.
Lots already products 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.