Optaflu
Expired
This medicine's authorisation has expired
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
MedicineHumanExpired
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Optaflu has expired following the marketing authorisation holder's decision not to apply for a renewal.
Optaflu : EPAR - Summary for the public
English (EN) (542.1 KB - PDF)
First published: Last updated:
български (BG) (626.94 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
español (ES) (543.18 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
čeština (CS) (607.18 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
dansk (DA) (542.38 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
Deutsch (DE) (544.72 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
eesti keel (ET) (569.2 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
ελληνικά (EL) (632.08 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
français (FR) (544.92 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
hrvatski (HR) (565.37 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
italiano (IT) (542.06 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
latviešu valoda (LV) (606.25 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
lietuvių kalba (LT) (568.74 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
magyar (HU) (604.87 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
Malti (MT) (612.39 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
Nederlands (NL) (542.82 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
polski (PL) (607.38 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
português (PT) (543.41 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
română (RO) (568.85 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
slovenčina (SK) (609.36 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
slovenščina (SL) (598.68 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
Suomi (FI) (542.05 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
svenska (SV) (542.7 KB - PDF)
First published: 22/02/2008Last updated: 02/12/2015
Product information
Optaflu : EPAR - Product Information
English (EN) (692.01 KB - PDF)
First published: Last updated:
български (BG) (1.44 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
español (ES) (709.15 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
čeština (CS) (1.14 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
dansk (DA) (697.84 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
Deutsch (DE) (713.45 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
eesti keel (ET) (693.64 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
ελληνικά (EL) (1.5 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
français (FR) (716.14 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
hrvatski (HR) (759.7 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
íslenska (IS) (702.84 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
italiano (IT) (706.73 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
latviešu valoda (LV) (1.21 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
lietuvių kalba (LT) (810.2 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
magyar (HU) (1.12 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
Malti (MT) (1.14 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
Nederlands (NL) (709.21 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
norsk (NO) (696.27 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
polski (PL) (1.19 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
português (PT) (705.71 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
română (RO) (814.95 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
slovenčina (SK) (1.13 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
slovenščina (SL) (1.12 MB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
Suomi (FI) (701.65 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
svenska (SV) (699.18 KB - PDF)
First published: 11/05/2009Last updated: 13/02/2017
Latest procedure affecting product information:
T/0091
12/12/2016
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).
Optaflu : EPAR - All Authorised presentations
English (EN) (461.19 KB - PDF)
First published: Last updated:
български (BG) (549.6 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
español (ES) (461.58 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
čeština (CS) (507.3 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
dansk (DA) (476.45 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
Deutsch (DE) (462.8 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
eesti keel (ET) (461.11 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
ελληνικά (EL) (523.54 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
français (FR) (461.82 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
hrvatski (HR) (487.48 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
íslenska (IS) (460.45 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
italiano (IT) (461.5 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
latviešu valoda (LV) (505.78 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
lietuvių kalba (LT) (492.41 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
magyar (HU) (516.83 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
Malti (MT) (532.54 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
Nederlands (NL) (462.12 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
norsk (NO) (461.46 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
polski (PL) (506.93 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
português (PT) (461.56 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
română (RO) (491.16 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
slovenčina (SK) (503.19 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
slovenščina (SL) (486.96 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
Suomi (FI) (461.13 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
svenska (SV) (461.66 KB - PDF)
First published: 12/09/2008Last updated: 22/09/2015
Product details
- Name of medicine
- Optaflu
- Active substance
- influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)
- International non-proprietary name (INN) or common name
- influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.
Optaflu should be used in accordance to official guidance.
Authorisation details
- EMA product number
- EMEA/H/C/000758
- Marketing authorisation holder
- Seqirus GmbH
Emil-von-Behring Strasse 76
35041 Marburg
Germany - Marketing authorisation issued
- 01/06/2007
- Expiry of marketing authorisation
- 05/06/2017
- Revision
- 16
Assessment history
Optaflu : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (809.01 KB - PDF)
First published: Last updated:
Optaflu-H-C-PSUSA-00001745-201504 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/146531/2016
English (EN) (523.75 KB - PDF)
First published: Last updated:
Optaflu-H-C-758-P46-0052 : EPAR - Assessment Report
AdoptedReference Number: EMA/CHMP/538134/2015
English (EN) (3.86 MB - PDF)
First published: Last updated:
Optaflu-H-C-758-P-46-0053 : EPAR - Assessment Report
AdoptedReference Number: EMA/250256/2015
English (EN) (4.13 MB - PDF)
First published: Last updated:
Optaflu-H-C-758-PSUV-0070 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/26383/2015
English (EN) (517.47 KB - PDF)
First published: Last updated:
More information on Optaflu
Public statement on Optaflu: Expiry of the marketing authorisation in the European Union
Reference Number: EMA/376617/2017
English (EN) (58.68 KB - PDF)
First published: Last updated:
More information on Optaflu
This page was last updated on