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)
Boehringer Ingelheim Ltd
QI02AQ01
Suspension for Injection
Immunological - Inactivated vaccine
Bovine
2000-12-23
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10007/034/001 Case No: 7003429 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: 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 TRICHOPHYTON 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 11/11/2007. 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 04/01/2008_ _CRN 7003429_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Insol Trichophyton suspension for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of inactivated vaccine contains: ACTIVE SUBSTANCE Minimum 17 x 10 6.0 microconidia of each of the following fungal strains: _- Trichophyton verrucosum_, strain no. 410 _- Trichophyton mentagrophytes_, strain no. 1032 _- Trichophyton sarkisovii_, strain no. 551 EXCIPIENT: Thiomersal: 0.040 mg For a full list of excipients see section Read the complete document