Država: Francija
Jezik: angleščina
Source: HMA (Heads of Medicines Agencies)
Inactivated Rabbit haemorrhagic Disease 1280 HAU
Pharmagal Bio s. r.o.
QI08AA01
Suspension for injection
Rabbit haemmorhagic disease virus vaccine
Rabbit Food
2010-08-27
ÚSTAV PRO STÁTNÍ KONTROLU VETERINÁRNÍCH BIOPREPARÁTŮ A LÉČIV INSTITUTE FOR STATE CONTROL OF VETERINARY BIOLOGICALS AND MEDICAMENTS CZECH REPUBLIC MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT CZ/V/0101/001/MR PRODUCT DETAILS Name of product CASTOREX Indication for use/target species For active immunization of rabbits to prevent mortality caused by RHD virus APPLICATION(S) DETAILS Type of application Mutual recognition Concerned member states Germany (DE) Applicant Pharmagal Bio, s.r.o. Murgašova 5 949 01 Nitra Slovak Republic RMS DETAILS Member state responsible for preparing the assessment report Czech Republic Date of preparation May 2006 Date product first authorised in the reference member state April 2000 CONTACT WITH THE RMS Address ÚSKVBL, Hudcova 56a, 62100 Brno, Czech Republic SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT CASTOREX INACTIVATED ADSORBED VACCINE AGAINST RABBIT HAEMORRHAGIC DISEASE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of vaccine (0,5 ml) contains: _Active substances : _ Inactivated Rabbit haemorrhagic disease virus ……min. 1280 HAU _Adjuvant : _ Aluminium hydroxide gel ............................ 0,75- 1,50 mg _ _ _Excipients: _ _ _Formaldehyde ……………………………… max. 0,90 mg Thiomersal ……………………………… max. 0,06 mg 3. PHARMACEUTICAL FORM Suspension for injection. Preberite celoten dokument