Reporting of suspected adverse drug reactions after marketing
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
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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
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
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
Ireland
Pharmacovigilance Section.
Irish Medicines Board
Website: www.imb.ie
E-mail: imbpharmacovigilance@imb.ie
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
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
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
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


