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.