Adverse reaction ?

An adverse reaction is an undesirable effect of a drug.

If you experience symptoms that you had not expected, or that are not included in the package leaflet, contact your doctor.

The doctor can assess whether the adverse reaction means that the treatment should be changed.

The doctor may also report side effect and add information from your medical record that can help assessment of the adverse reaction.

We encourage that the reporting is done through your own doctor. However, it is possible to report the adverse reaction directly to Azanta at the following address:

fax: +45 38 33 02 80
e-mail: pharmacovigilance@a-consult.dk

It is also possible to report via the pharmacy or even report them via the national reporting system listed below.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed below.

België/Belgique/Belgien

Dutch
Federaal agentschap voor geneesmiddelen en gezondheidsproducten
Afdeling Vigilantie
EUROSTATION II
Victor Hortaplein, 40/ 40
B-1060 Brussel

Melding door gezondheidszorgbeoefenaars
Website: www.fagg.be 
e-mail: adversedrugreactions@fagg-afmps.be
Melding door patiënten
Website: www.fagg.be
e-mail: patientinfo@fagg-afmps.be

French
Agence fédérale des médicaments et des produits de santé
Division Vigilance
EUROSTATION II
Place Victor Horta, 40/ 40
B-1060 Bruxelles

Notification par les professionnels de la santé
Site internet: www.afmps.be
e-mail: adversedrugreactions@fagg-afmps.be

Notification par les patients
Site internet: www.afmps.be
e-mail: patientinfo@fagg-afmps.be

German
Föderalagentur für Arzneimittel und Gesundheitsprodukte
Abteilung Vigilanz
EUROSTATION II
Victor Hortaplein, 40/40
B-1060 BRUSSEL
Patientenmeldung
Website: www.fagg-afmps.be
E-Mail: patientinfo@fagg-afmps.be

Denmark
Sundhedsstyrelsen
Axel Heides Gade 1
DK-2300 København S
Websted: www.meldenbivirkning.dk
E-mail: sst@sst.dk

Germany
Bundesinstitut für Arzneimittel und Medizinprodukte
Abt. Pharmakovigilanz
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: http://www.bfarm.de

[For vaccines/biological medicinal products]

Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Paul-Ehrlich-Institut
Paul-Ehrlich-Str. 51-59
63225 Langen

Tel: +49 6103 77 0
Fax: +49 6103 77 1234
Website: www.pei.de

Luxembourg/Luxemburg
Direction de la Santé - Division de la Pharmacie et des Médicaments
Villa Louvigny - Allée Marconi
L-2120 Luxembourg
Site internet: http://www.ms.public.lu/fr/activites/pharmacie-medicament/index.html

Nederland
Nederlands Bijwerkingen Centrum Lareb
Website: www.lareb.nl

Norge
Statens legemiddelverk

For leger og helsepersonell
Nettside: www.legemiddelverket.no/meldeskjema

For pasienter
Nettside: www.legemiddelverket.no/pasientmelding

Suomi/Finland
www.fimea.fi
Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Lääkkeiden haittavaikutusrekisteri
PL 55
FI-00034 Fimea

Sverige
Läkemedelsverket
Box 26
751 03 Uppsala
Webbplats: www.lakemedelsverket.se

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Azanta A/S, Gearhalsvej 1, DK-2500 Valby, Denmark, Phone +45 7025 9545, Fax: +45 7025 9546, Mail: info@azanta.com

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