RONAXAN 20 MG TABLET
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
05-05-2024
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Ingredient activ:
DOXYCYCLINE HYCLATE
Disponibil de la:
Merial Animal Health Limited
Codul ATC:
QJ01AA02
Dozare:
20 mg/tablet
Forma farmaceutică:
Tablets
Grupul Terapeutică:
Antibacterial
Zonă Terapeutică:
Canine
Data de autorizare:
1995-10-12
Caracteristicilor produsului
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10857/017/001
Case No: 7007832
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, UNITED KINGDOM
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:
RONAXAN 20 MG TABLET
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 03/09/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/09/2010_
_CRN 7007832_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ronaxan 20 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCE :
Doxycycline
20 mg
(as doxycycline hyclate)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Round, biconvex, light yellow to yellow tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory tract infections in cats and dogs, including rhinitis, tonsillitis
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