Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
AUJESZKY'S DISEASE VIRUS STRAIN BEGONIA
Intervet Ireland Limited
QI09AD01
Lyophilisate for suspension for injection
Immunological - Live Vaccine
Porcine
2000-07-21
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10996/084/001 Case No: 7006433 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: INTERVET IRELAND LIMITED MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, IRELAND 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: PORCILIS BEGONIA IDAL LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INTRADERMAL APPLICATION IN PIGS 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 07/07/2010. 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 10/07/2010_ _CRN 7006433_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Begonia IDAL Lyophilisate and solvent for suspension for intradermal application in pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lyophilisate: ACTIVE SUBSTANCE: Live Aujeszky’s disease virus strain Begonia (gE – , tk – ): 10 5.5 - 10 6.5 TCID 50 * per dose of 0.2 ml. Solvent (Diluvac Forte): ADJUVANT: dl- -tocopheryl acetate: 75.0 mg/ml EXCIPIENTS: For a full list of excipients, see section 6.1 * TCID 50 : tissue cultur Belgenin tamamını okuyun