Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
DOXYCYCLINE HYCLATE
Virbac S.A.
QJ01AA02
60 mg/g
Oral Paste
Antibacterial
Canine
2002-06-28
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10988/064/001 Case No: 7000270 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to: VIRBAC LABORATORIES 1 ERE AVENUE - 2065 M, L.I.D., 06516 CARROS CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: PULMODOX 60MG/G ORAL PASTE FOR SMALL SIZED DOGS The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. The authorisation, unless previously revoked, shall continue in force from 15/01/2006 until 14/01/2011. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/11/2006_ _CRN 7000270_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmodox 60 mg/g oral paste for small sized dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Pulmodox Oral Paste contains: Active substance(s): Doxycycline (as hyclate form).............................. 60 mg Excipient(s): Butylhydroxyanisole (E320).............................. 0,18 mg One syringe contains 5 g of paste For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral paste 4 CLINICAL PARTICULARS 4.1 T Pročitajte cijeli dokument