The Pharmacovigilance Service of SC BIOFARM SA responds to a public health problem, having an important role for the safety of patients and a significant contribution to the transmission of the correct information to the consumers, to promoting the rational use and to the permanent analysis of the benefit-risk ratio for the drugs in the portfolio. of our company.
What is Pharmacovigilance?
Pharmacovigilance studies the safety of drugs by detecting, evaluating, reporting / monitoring and preventing adverse reactions.
What is an adverse reaction?
An adverse reaction is defined as “a harmful and unwanted response, determined by a drug”. This means that an undesirable or unintended effect occurs after using a medicine. Adverse reactions and undesirable effects that occur after drug overdose, misuse, abuse and medication errors, or undesirable effects of occupational exposure are considered adverse reactions.
If you get any side effects, talk to your doctor or pharmacist. These include any side effects mentioned or not in the package leaflet.
How can an adverse reaction be reported?
If you want to report a suspected adverse reaction to any of the BIOFARM medicines:
- you can contact us by email at (firstname.lastname@example.org) or by phone at (316.48.32);
- you can report directly here;
All personal information related to reporting a side effect is processed in accordance with EU / European data protection law. Your report is used only for the scientific evaluation of the drug.
- you can report here to the National Agency for Medicines and Medical Devices in Romania (ANMDMR)
By reporting side effects, you can help provide more information on the safety of BIOFARM medicines.
For more information on the safety of BIOFARM medicines you can contact the Pharmacovigilance department: