Review Product Marketing Authorisation For Veterinary Use «Marfloxin Ecani», «5 Mg Tablets For Cats Marfloxin 20 Mg Tablets For Dogs» And «Marfloxin 80 Mgcompresse For Dogs».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Marfloxin 5 mg compresse per gatti ecani», «Marfloxin 20 mg compresse per cani» e «Marfloxin 80 mgcompresse per cani».

Read the untranslated law here:

Extract from the measure # 76 of February 4, 2015 veterinary medicinal product MARFLOXIN 5 mg tablets for cats and dogs-MARFLOXIN 20 mg tablets for dogs-MARFLOXIN 80 mg tablets for dogs (A.I.C. Nos 104492).
A.I.C. holder: KRKA, d.d., Novo mesto-Šmarješka cesta 6-8501 Novo mesto-Slovenia.
The object of the measure: European Procedure Number: UK/V/003/IA/001/001-0430.
You authorize the addition of site TAD Pharma GmbH, Heinz-Lohmann-Str. 5-27472 Cuxhaven-Germany as a site responsible for batch release of the finished product.
The change above changes the leaflet 1 point, as follows: 1. The name and address of the marketing authorisation holder and the manufacturing authorisation holder responsible for batch release if different manufacturing authorisation holder: Krka d.d., Novo Mesto-Smarjeska cesta 6-8501 Novo mesto-Slovenia.
The manufacturing authorisation holder of the batch release: Krka d.d., Novo Mesto-Smarjeska cesta 6-8501 Novo mesto-Slovenia or TAD Pharma GmbH-Heinz Lohmann-27472 Cuxhaven-Germany 5-Str.
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 company concerned.