Reporting of suspected adverse drug reactions after marketing authorisation of a medicinal product is important. It allows continued monitoring of its benefit/risk balance. Healthcare professionals are therefore asked to report any suspected adverse reactions through either local health agency’s pharmacovigilance department (listed hereafter), or by email to BIOCODEX’s pharmacovigilance department to the following address: vigilance@biocodex.fr

Austria

Bundesamt für Sicherheit im Gesundheitswesen
Website: http://www.basg.gv.at/

Belgium

Dutch

Federaal agentschap voor geneesmiddelen en gezondheidsproducten
Afdeling Vigilantie
Website: www.fagg.be

Melding door gezondheidszorgbeoefenaars
e-mail: adversedrugreactions@fagg-afmps.be

Melding door patiënten
e-mail: patientinfo@fagg-afmps.be

French

Agence fédérale des médicaments et des produits de santé
Division Vigilance
Site internet: www.afmps.be

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

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

German

Föderalagentur für Arzneimittel und Gesundheitsprodukte
Abteilung Vigilanz
Website: www.fagg-afmps.be

Patientenmeldung
E-Mail: patientinfo@fagg-afmps.be

Bulgaria

Изпълнителна агенция по лекарствата ул.
уебсайт: www.bda.bg

Canada

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or
  • Mail to:
    Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario
    K1A 0K9

Cyprus

Φαρμακευτικές Υπηρεσίες
Υπουργείο Υγείας
Ιστότοπος: www.moh.gov.cy/phs

Czech Republic

Státní ústav pro kontrolu léčiv
Webové stránky: www.sukl.cz/nahlasit-nezadouci-ucinek

Denmark

Sundhedsstyrelsen
Websted: www.meldenbivirkning.dk
E-mail: sst@sst.dk

Estonia

Ravimiamet
Koduleht: www.ravimiamet.ee

Finland

Finnish

www-sivusto: www.fimea.fi
Lääkealan turvallisuus – ja kehittämiskeskus Fimea
Lääkkeiden haittavaikutusrekisteri

Swedish

webbplats: www.fimea.fi
Säkerhets- och utvecklingscentret för läkemedelsområdet Fimea
Biverkningsregistret

France

Agence nationale de sécurité du médicament et des produits de santé (Ansm) et réseau des Centres Régionaux de Pharmacovigilance .
Site internet: www.ansm.sante.fr

Germany

Bundesinstitut für Arzneimittel und Medizinprodukte.
Website: http://www.bfarm.de

For vaccines/biological medicinal products
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Website: www.pei.de

Greece

Εθνικός Οργανισμός Φαρμάκων.
Ιστότοπος: http://www.eof.gr

Iceland

til Lyfjastofnunar: www.lyfjastofnun.is

Ireland

Pharmacovigilance Section.
Irish Medicines Board
Website: www.imb.ie
E-mail: imbpharmacovigilance@imb.ie

Italia

Agenzia Italiana del Farmaco
Sito web: http://www.agenziafarmaco.gov.it/it/responsabili

Latvia

Zāļu valsts aģentūra
Tīmekļa vietne: www.zva.gov.lv

Lithuania

VVKT prie LR SAM
El. paštas: NepageidaujamaR@vvkt.lt
Interneto svetainė: www.vvkt.lt

Luxemburg

Direction de la Santé – Division de la Pharmacie et des Médicaments
Site web: http://www.ms.public.lu/fr/activites/pharmacie-medicament/index.html

Malta

ADR Reporting
The Medicines Authority
Website: www.medicinesauthority.gov.mt
E-mail: postlicensing.medicinesauthority@gov.mt

Netherlands

Nederlands Bijwerkingen Centrum Lareb
Website: www.lareb.nl

Norway

Statens legemiddelverk
Nettside: www.legemiddelverket.no/pasientmelding

Poland

Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
E-mail: adr@urpl.gov.pl

Portugal

INFARMED, I.P
Direção de Gestão do Risco de Medicamentos
Sítio da internet: http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage
E-mail: farmacovigilancia@infarmed.pt

Romania

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale
E-mail: adr@anm.ro

Slovakia

Štátny ústav pre kontrolu liečiv
Sekcia bezpečnosti liekov a klinického skúšania
internetová stránka: http://www.sukl.sk/sk/bezpecnost-liekov
E-mail: neziaduce.ucinky@sukl.sk

Slovenia

Univerzitetni klinični center Ljubljana, Interna klinika
E-mail: farmakovigilanca@kclj.si

Spain

Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es

Sweden

Läkemedelsverket
Webbplats: www.lakemedelsverket.se

United Kingdom

Yellow Card Schemea
Website: www.mhra.gov.uk/yellowcard

Regarding DIACOMIT®, you also may report these side effects to the company providing it in your country:

Regarding all other countries in the world, please contact BIOCODEX through vigilance@biocodex.fr