Interested in the safety of using HELCOR medicines

The pharmacovigilance system related to the AC HELCOR Pharmaceutical Company applies to both marketing authorization holders: AC HELCOR and AC HELCOR PHARMA and has as its permanent objective the continuous monitoring of the safety of the medicines in our portfolio.

What is Pharmacovigilance?

The pharmacovigilance includes all the activities of detection, evaluation, validation and prevention of adverse reactions.

What is an adverse reaction?

An adverse reaction is defined as “a harmful and unwanted response caused by a drug”. This means that an unwanted or unintended effect occurs after you have used a medicine. Adverse reactions and unwanted effects that occur after drug overdose, misuse, abuse and medication errors or unwanted effects that occur as a result of professional exposure.

Who can report suspected adverse reactions?

• • patients
  • legal representatives of patients
  • the people who provide patient care
  • health care professionals.

What are the minimum elements for the establishment of an Adverse Reaction Report?

• • the existence of an identifiable reporter (by name and contact details)
  • of an identifiable patient (by initials, date of birth, age, sex)
  • of a suspected adverse reaction
  • of a suspected drug

How can you report an adverse reaction?

You can report an adverse reaction to any of the drugs in the AC HELCOR portfolio:

• • National Agency of Medicines and Medical Devices in Romania (ANMDMR), by accessing the direct link here.
  • The AC HELCOR pharmacovigilance system, by e-mail (office@achelcor.ro), telephone (+40362401206) or by filling in one of the forms below and sending it to office@achelcor.ro.
    • Patient file
    • Health professional card (can be used by doctors, pharmacists, medical and pharmacy assistants).

By reporting adverse reactions associated with medicines for human use, you contribute to providing additional information regarding their safety and, thus, to protecting your health and that of other people. All personal information related to the reporting of an adverse reaction is processed in accordance with EU data protection legislation.