HATCHPACK IB H120
देश: ऑस्ट्रिया
भाषा: अंग्रेज़ी
स्रोत: HMA (Heads of Medicines Agencies)
सूचना पत्रक
(PIL)
10-01-2013
उत्पाद विशेषताएं
(SPC)
10-01-2013
सक्रिय संघटक:
Infectious Bronchitis Virus 3.7 log10 EID50
थमां उपलब्ध:
Merial
ए.टी.सी कोड:
QI01AD07
फार्मास्यूटिकल फॉर्म:
Aqueous Suspension
चिकित्सीय समूह:
Avian infectious bronchitis virus vaccine
चिकित्सीय क्षेत्र:
Chicken
प्राधिकरण की तारीख:
2011-08-17
सूचना पत्रक
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First round, where MA withdrawn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* these countries have registered the vaccine in 2007, but MA was withdrawn thereafter; they are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
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