Bayovac IBR-Marker inactivatum
Țară: Franța
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
Prospect
(PIL)
19-03-2013
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Trimite cerere.
Trimite cerere.
Ingredient activ:
bovine herpesvirus inactivated 2 ml
Disponibil de la:
Pfizer GmbH
Codul ATC:
QI02AA03
Forma farmaceutică:
Suspension for injection
Grupul Terapeutică:
IMMUNOLOGICALS
Zonă Terapeutică:
Cattle
Data de autorizare:
2011-05-25
Prospect
Paul-Ehrlich-Institut
DE/V/0021/001/II/014
Page 1
Paul-Ehrlich-Institut
Paul-Ehrlich-Straße 51-59
Telefon 0 61 03/77-0
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel D-63225 Langen
Telefax 0 61 03/77-123
Federal Institute for Vaccines and Biomedcines
Postfach D-63207 Langen
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
FINALISATION REPORT ON VARIATION TYPE II
PRODUCT DETAILS
Name of products
RISPOVAL IBR-MARKER INACTIVATUM
Active ingredient(s)
Inactivated Bovine Herpes Virus Type 1 (BoHV-1), strain
Difivac (gE-negative)
Target Species
Cattle
APPLICATION(S) DETAILS
Type of application
VARIATION TYPE II:
Change the recommendations for booster vaccinations
(C.I.4, Typ II)
Name and address of Applicant
Pfizer Limited
Ramsgate Road
Sandwich, Kent CT13 9NJ
United Kingdom
+32 (0) 27157512
e-mail:
frederic.descamps@pfizer.com
List of CMS
BE, BG, CZ, EE, ES, FR, HU, IE, IT, LT, LU, LV, NL, PL, PT,
RO, SI, SK, UK
ORIGINATING MEMBER STATE DETAILS
RMS
GERMANY
Date of preparation and assessor 02. October, 2012 / Dr Brigitte Küchler
Marketing authorisation number
497A/93
Decentralised Procedure
Reference Number
DE/V/0021/001/II/014
CONTACT WITH THE ORIGINATING MEMBER STATE
Contact name
Dr Brigitte Küchler / Dr Ingun Lemke
Address
Paul-Ehrlich-Institut
Paul-Ehrlich-Str. 51-59, D-63225 Langen
Phone and fax numbers
+49-6103-77-7454 / -7456
+49-6103-77-1254
E-Mail address (if available)
Brigitte.Kuechler@pei.de
,
Ingun.Lemke@pei.de
Paul-Ehrlich-Institut
DE/V/0021/001/II/014
Page 2
KEY DATES
Variation Procedure Start Date (day 0)
25.04.2012 (Wed)
Date of Preparation of PVAR (day 40)
04.06.201
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