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For medical specialists

Report form for medical specialists

Instructions for adverse drug reactions reporting:

Adverse drug reaction is any unwanted and unforeseen effect to a medicine. The accompanying leaflet contains important safety information which the user must familiarize with prior to use. The section "Adverse Drug Reactions" contains a description of reactions which have already been observed and advice what to do if they occur.

If you get any side effects , contact your doctor or pharmacist. This includes all non described adverse reactions in the leaflet . As reported side effects, you can do your bit to obtain more information on the safety of this medicine.

The personal data of the reporter/patient shall be protected and shall be treated in accordance with the Personal Data Protection Act and in accordance with the recommendations and principles issued by the European Data Protection Supervisor.

To report an adverse reaction related to a pharmaceutical product whose holder of authorization is Bestamed Ltd please contact us by:

  • Completing and sending the form TO REPORT ADVERSE REACTIONS
  • 24/7 phone: +359 2 442 62 62
  • E-mail: safety@bestamed.com

You can also report adverse reactions directly through the national reporting system to the Bulgarian Drug Agency - No 8, Damian Gruev str., postal code 1303, Sofia, telephone +35928903417, web: www.bda.bg

 

Form for adverse reactions reporting by medical specialists

Please, note that health care professionals that are required according to the provisions of the MPHMA to report to the Bulgarian Drug Agency (BDA) and to the Marketing Authorization Holder any suspected serious or unexpected adverse reactions, regardless of whether the product is used or not in accordance with the Summary of Product Characteristics.


I agree to submit my data in reporting an adverse event and I am aware that data are not recorded on the website.

Download the adverse reaction reporting form here