Overview
The marketing authorisation for Daronrix has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Daronrix : EPAR - Summary for the public
English (EN)
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български (BG)
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español (ES)
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čeština (CS)
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dansk (DA)
(182.9 KB - PDF)
Deutsch (DE)
(185.45 KB - PDF)
eesti keel (ET)
(178.95 KB - PDF)
ελληνικά (EL)
(383.32 KB - PDF)
français (FR)
(184.47 KB - PDF)
italiano (IT)
(183.55 KB - PDF)
latviešu valoda (LV)
(387.16 KB - PDF)
lietuvių kalba (LT)
(325.44 KB - PDF)
magyar (HU)
(339.88 KB - PDF)
Malti (MT)
(392.73 KB - PDF)
Nederlands (NL)
(183.66 KB - PDF)
polski (PL)
(399.29 KB - PDF)
português (PT)
(183.97 KB - PDF)
română (RO)
(323.65 KB - PDF)
slovenčina (SK)
(350.6 KB - PDF)
slovenščina (SL)
(326.67 KB - PDF)
Suomi (FI)
(179.34 KB - PDF)
svenska (SV)
(179.51 KB - PDF)
Product information
Daronrix : EPAR - Product Information
English (EN)
(634.97 KB - PDF)View
български (BG)
(1 MB - PDF)
español (ES)
(634.33 KB - PDF)
čeština (CS)
(713.58 KB - PDF)
dansk (DA)
(601.39 KB - PDF)
Deutsch (DE)
(591.25 KB - PDF)
eesti keel (ET)
(624.03 KB - PDF)
ελληνικά (EL)
(799.06 KB - PDF)
français (FR)
(657.41 KB - PDF)
italiano (IT)
(521.62 KB - PDF)
latviešu valoda (LV)
(733.4 KB - PDF)
lietuvių kalba (LT)
(666.14 KB - PDF)
magyar (HU)
(666.77 KB - PDF)
Suomi (FI)
(640.98 KB - PDF)
21/03/2007
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).
Daronrix : EPAR - All Authorised presentations
English (EN)
(139.62 KB - PDF)View
български (BG)
(224.75 KB - PDF)
español (ES)
(143.12 KB - PDF)
čeština (CS)
(220.6 KB - PDF)
dansk (DA)
(143.24 KB - PDF)
Deutsch (DE)
(143.07 KB - PDF)
eesti keel (ET)
(140.49 KB - PDF)
ελληνικά (EL)
(226.28 KB - PDF)
français (FR)
(143.25 KB - PDF)
íslenska (IS)
(140.52 KB - PDF)
italiano (IT)
(139.76 KB - PDF)
latviešu valoda (LV)
(216.85 KB - PDF)
lietuvių kalba (LT)
(211.85 KB - PDF)
magyar (HU)
(216.97 KB - PDF)
Nederlands (NL)
(142.82 KB - PDF)
norsk (NO)
(142.91 KB - PDF)
polski (PL)
(220.44 KB - PDF)
português (PT)
(142.99 KB - PDF)
română (RO)
(208.99 KB - PDF)
slovenčina (SK)
(216.7 KB - PDF)
slovenščina (SL)
(187.52 KB - PDF)
Suomi (FI)
(140.1 KB - PDF)
svenska (SV)
(143.26 KB - PDF)
Product details
- Name of medicine
- Daronrix
- Active substance
- Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs
- International non-proprietary name (INN) or common name
- pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Disease Outbreaks
- Anatomical therapeutic chemical (ATC) code
- J07BB01
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Assessment history
This page was last updated on