Report a Side Effect

Are you a patient / legal representative of the patient / caregiver or health care provider?

Patient information for reporting adverse drug reactions (ADR):

The Health Authorities encourages patients, patients’ legal representatives, patient caregivers, and healthcare professionals (physicians, pharmacists, nurses) to report suspected adverse reactions/side effects to drugs and vaccines. By reporting side effects, you can help provide additional information on the safety of medicines and vaccines and thus protect your health and the health of other people.

If you get any side effects, talk to your doctor or pharmacist. These include any possible side effects that may or may not be mentioned in the patient information leaflet. Your doctor or pharmacist will advise you if you need medical treatment or if you need to stop or change your treatment.

If you are pregnant or planning to become pregnant and are on medication, you should consult your doctor if you need to stop or change your treatment.

What is an adverse reaction (ADR)?

An adverse reaction is defined as a response to a medicinal product which is noxious and unintended. Other undesirable events/effects that occur after overdose, misuse, abuse, medication errors, off-label use, occupational exposure and from products with quality defects or suspected to be falsified should be considered adverse events reports and should be reported accordingly.

How can you report an adverse reaction (ADR)?

You can report a suspected adverse reaction to a medicine (including a vaccine) in the following ways:

• You can tell your doctor or pharmacist, who will report the suspected ADR either to Health Authority, the Pharmacovigilance Department, or to the pharmaceutical company that holds the marketing authorization (MAH) for that medicine or to its local/regional PV Representative,
• You can submit the filled in ADR form directly to:
  • Regional PV Representative/MAH: Amring Farma SRL, 7 Mircea Eliade Bvd, 012011, Bucharest, Romania, email: ro.pharmacovigilance@nordicpharma.com;
    Tel: +40316201204;
  • Pharmacovigilance Headquarter/MAH: Nordic Group BV, 216 Bd Saint Germain 75007 Paris – France, email: pv@nordicpharma.com, Tel: +33 (0)1 70 37 28 02

• If applicable, you may fill in your electronic “ADR Form” available on your local Health Authority platform/website or you can submit directly via email/phone call to the Pharmacovigilance Department of your local Health Authority.

Please note that by completing a reporting form you agree to the processing of the information provided, including your contact details, in compliance with applicable laws for the protection of individuals with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation (EU) 2016/679, with subsequent amendments and completions). Summary details of the adverse reaction report (excluding personal information) may be shared with other bodies involved in monitoring activities. Those data are kept for a compliant period required by law. You have the right to access and correct by contacting us at ro.pharmacovigilance@nordicpharma.com. You can also make a complaint to our Data Protection Officer by email at dataprivacy@nordicpharma.com and to the CNIL in the event of infringement of your rights.

Where can you find information on side effects?

The patient information leaflet provides the user information. At chapter 4 – POSSIBLE SIDE EFFECTS of the patient information leaflet, you will find information about the possible side effects associated with the medicine. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You should read the patient information leaflet carefully before you start using this medicine because it contains important information for you.