Ülke: Almanya
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
bovine herpesvirus inactivated 2 ml
Pfizer GmbH
QI02AA03
Suspension for injection
IMMUNOLOGICALS
Cattle
2011-05-25
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 Belgenin tamamını okuyun