Country: Իռլանդիա
language: անգլերեն
source: HMA (Heads of Medicines Agencies)
Infectious Bronchitis Virus 3.7 log10 EID50
Merial
QI01AD07
Aqueous Suspension
Avian infectious bronchitis virus vaccine
Chicken
2011-08-17
HATCHPAK IBH120 FR/V/0171/001/E/001 Merial Repeat-use Final assessment report Page 1 of 304 AG ENCE NATIONALE DU MEDICAMENT VETERINAIRE HATCHPAK IB H120 APPLICANT : MERIAL FINAL ASSESSMENT REPORT REPEAT-USE PROCEDURE N° FR/V/0171/001/E/001 PRODUCT DETAILS Name of product HATCHPAK IB H120 Active ingredients Live infectious Bronchitis virus, H120 strain Target species Chickens APPLICATION DETAILS Type of application Mutual recognition Procedure – repeat use Name of applicant Merial Date of receipt of request for assessment report 19/10/2012 Person for communication on behalf of the applicant during the procedure Nathalie BOURGUIGNON-GELE Nathalie.bourguignon-gele@merial.com 33 4 72 72 31 11 Timetable Clock start : 24/01/2013 Day 54 : 19/03/2013 Day 78 : 12/04/2013 Day 90 : 24/04/2013 New concerned Member States AT*, BE*, BG, CY, IE*, NL*, RO, SI, UK* Initial Concerned Member States First round, where MA still valid CZ, DE, EL, ES, HU, IT, LT, LV, PL, SK Initial Concerned Member States First round, where MA withdrawn AT*, BE*, FI, IE*, LU, NL*, UK* * these countries have registered the vaccine in 2007, but MA was withdrawn thereafter; they are now involved in the repeat-use REFERENCE MEMBER STATE DETAILS Assessment report prepared by France Date of preparation 24/04/2013 Date of the first marketing authorisation in the RMS 14/09/2007 Contact Name Dr Céline Lorteau Address ANSES - ANMV 8 rue Claude Bourgelat - Parc d'activités de la Grande Marche - Javené - BP 90203 35302 Fougères Cedex - FRANCE Phone 33 2 99 94 78 60 (or 33 2 99 94 78 82) HATCHPAK IBH120 FR/V/0171/001/E/001 Mer read_full_document