Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRICHOPHYTON VERRUCOSUM STRAIN NO.410 (MICROCONIDIA) TRICHOPHYTON MENTAGROPHYTES STRAIN NO.1032 (MICROCONIDIA) TRICHOPHYTON SARKISOVII STRAIN NO.551 (MICROCONIDIA) TRICHOPHYTON EQUINUM, STRAIN NO. 381 MICROSPORUM CANIS, STRAIN NO. 1393 MICROSPORUM CANIS, VAR. DISTORTUM, STRAIN NO. 120 MICROSPORUM CANIS VAR. OBESUM, STRAIN NO. 1311 MICROSPORUM GYPSEUM, STRAIN NO. 59
Boehringer Ingelheim Ltd
QI05AQ
Suspension for Injection
Immunological - Inactivated vaccine
Canine
2002-08-15
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007 (S.I. NO. 144 OF 2007) VPA: 10007/039/001 Case No: 7002447 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to: BOEHRINGER INGELHEIM LTD ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, ENGLAND 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: INSOL DERMATOPHYTON SUSPENSION FOR INJECTION FOR HORSES, DOGS AND CATS 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 23/02/2007. 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 24/05/2007_ _CRN 7002447_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Insol Dermatophyton suspension for injection for horses, dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of inactivated vaccine contains: Prior to inactivation: Minimum: 55 x 10 6 microconidia of each of the following fungal strains in equal quantity to stimulate at least satisfactory protection in the rabbit potency test. Maximum: 65 x 10 6 microconidia of each of the following Read the complete document