Celvapan
Withdrawn
This medicine's authorisation has been withdrawn
influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Celvapan has been withdrawn at the request of the marketing-authorisation holder.
Celvapan : EPAR - Summary for the public
English (EN) (549.66 KB - PDF)
First published: Last updated:
български (BG) (633.17 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
español (ES) (569.5 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
čeština (CS) (612.73 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
dansk (DA) (550.05 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Deutsch (DE) (549.15 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
eesti keel (ET) (549.03 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
ελληνικά (EL) (659.25 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
français (FR) (572.11 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
hrvatski (HR) (568.03 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
italiano (IT) (553.19 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
latviešu valoda (LV) (592.85 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
lietuvių kalba (LT) (592.49 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
magyar (HU) (607.23 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Malti (MT) (597.98 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Nederlands (NL) (570.54 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
polski (PL) (634.29 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
português (PT) (547.79 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
română (RO) (571.44 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
slovenčina (SK) (612.83 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
slovenščina (SL) (624.2 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Suomi (FI) (570.2 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
svenska (SV) (571.48 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Product information
Celvapan : EPAR - Product Information
English (EN) (687.18 KB - PDF)
First published: Last updated:
български (BG) (1.44 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
español (ES) (700.53 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
čeština (CS) (1.12 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
dansk (DA) (715.13 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
Deutsch (DE) (704.69 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
eesti keel (ET) (683.21 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
ελληνικά (EL) (1.44 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
français (FR) (703.87 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
hrvatski (HR) (720.88 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
íslenska (IS) (693.1 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
italiano (IT) (699.23 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
latviešu valoda (LV) (1.18 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
lietuvių kalba (LT) (770.71 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
magyar (HU) (1.08 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
Malti (MT) (1.14 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
Nederlands (NL) (697.18 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
norsk (NO) (686.07 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
polski (PL) (1.14 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
português (PT) (697.57 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
română (RO) (781.1 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
slovenčina (SK) (1.11 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
slovenščina (SL) (1.06 MB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
Suomi (FI) (690.48 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
svenska (SV) (693.11 KB - PDF)
First published: 15/11/2009Last updated: 21/12/2016
Latest procedure affecting product information:
T/0031
30/11/2015
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Celvapan : EPAR - All Authorised presentations
English (EN) (477.52 KB - PDF)
First published: Last updated:
български (BG) (570 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
español (ES) (478.2 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
čeština (CS) (559.31 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
dansk (DA) (477.83 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Deutsch (DE) (478.19 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
eesti keel (ET) (478.75 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
ελληνικά (EL) (563.99 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
français (FR) (478.69 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
hrvatski (HR) (496.33 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
íslenska (IS) (477.98 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
italiano (IT) (477.68 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
latviešu valoda (LV) (560.32 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
lietuvių kalba (LT) (547.85 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
magyar (HU) (558.86 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Malti (MT) (561.05 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Nederlands (NL) (478.02 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
norsk (NO) (478.33 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
polski (PL) (566.34 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
português (PT) (478.44 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
română (RO) (546.88 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
slovenčina (SK) (558.97 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
slovenščina (SL) (527.15 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Suomi (FI) (478.01 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
svenska (SV) (478.01 KB - PDF)
First published: 08/10/2009Last updated: 21/12/2016
Product details
- Name of medicine
- Celvapan
- Active substance
- Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v
- International non-proprietary name (INN) or common name
- influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
- Therapeutic area (MeSH)
- Disease Outbreaks
- Influenza, Human
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BB01
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza caused by A(H1N1)v 2009 virus.
Celvapan should be used in accordance with official guidance.
Authorisation details
- EMA product number
- EMEA/H/C/000982
- Marketing authorisation holder
- Nanotherapeutics Bohumil, s.r.o.
Bohumill38
28163 Jevany
Czech Republic - Marketing authorisation issued
- 04/03/2009
- Revision
- 11
Assessment history
Celvapan : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (603.8 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-II-0019-G : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/664781/2012
English (EN) (761.69 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-II-0017-G : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/CHMP/283690/2011
English (EN) (662.79 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-SW-0014 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/CHMP/487986/2010
English (EN) (593.57 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-II-0012 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/257008/2010
English (EN) (593.57 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-II-0009 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/843807/2009
English (EN) (757.83 KB - PDF)
First published: Last updated:
Celvapan-H-C-832-II-0006 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMEA/CHMP/733392/2009
English (EN) (596.65 KB - PDF)
First published: Last updated:
Celvapan-H-C-982-PU-0002 : EPAR - Assessment Report - Variation
Reference Number: EMEA/CHMP/629184/2009
English (EN) (1.75 MB - PDF)
First published: Last updated:
More information on Celvapan
Public statement on Celvapan: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/820174/2016
English (EN) (65.7 KB - PDF)
First published: Last updated:
This page was last updated on