Review Product Marketing Authorisation For Veterinary Sirdis 2.5 Mg Tablets-Coated Tablets For Dogs, Sirdis 5 Mg Film-Coated Tablets For Dogs, Sirdis 20 Mg Film-Coated Tablets For Dogs. (15 ...

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario Sirdis 2,5 mg compresse rivestite confilm per cani, Sirdis 5 mg compresse rivestite con film per cani,Sirdis 20 mg compresse rivestite con film per cani. (15...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-09&atto.codiceRedazionale=15A00788&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved 18 January 9, 2015 # the provision of veterinary medicinal product SIRDIS 2.5 mg film-coated tablets for dogs, SIRDIS 5 mg film-coated tablets for dogs, SIRDIS 20 mg film-coated tablets for dogs (A.I.C. 104142 numbers).
A.I.C. Holder: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland.
The subject of the order: type IA Variation, b. II. e. 5. A1: change the size of the packaging of the finished product. Changing the number of units (tablets, ampoules, etc.) in a package within currently approved packaging size limits.
You authorize the addition of the following new packages: Sirdis 2.5 mg film-coated tablets for dogs, the packaging: box of 56 tablets-A.I.C. # 104142118;
Sirdis 5 mg film-coated tablets for dogs, the packaging: box of 56 tablets-A.I.C. # 104142120;
Sirdis 20 mg film-coated tablets for dogs, the packaging: box of 56 tablets-A.I.C. # 104142132.
Therefore the packs now authorised are as follows: Sirdis 2.5 mg film-coated tablets for dogs: box of 14 tablets-A.I.C. # 104142056;
box of 28 tablets-A.I.C. # 104142031;
box of 140 tablets-A.I.C. # 104142094;
box of 56 tablets-A.I.C. # 104142118;
Sirdis 5 mg film-coated tablets for dogs: box of 14 tablets-A.I.C. # 104142017;
box of 28 tablets-A.I.C. # 104142068;
box 84 tablets-A.I.C. # 104142029;
box of 140 tablets-A.I.C. # 104142082;
box of 56 tablets-A.I.C. # 104142120;
Sirdis 20 mg film-coated tablets for dogs: box of 14 tablets-A.I.C. # 104142043;
box of 28 tablets-A.I.C. # 104142070;
box of 140 tablets-A.I.C. # 104142106;
box of 56 tablets-A.I.C. # 104142132.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.