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Pharmacovigilance relates to the detection, assessment, understanding and prevention of adverse events (side-effects) and any other medicine-related problem.

Its aim is to improve patient care and safety, to ensure public health and safety in relation to the use of medicines and to promote understanding, training and effective communication to healthcare professionals and the public.

Countries have regulations and laws that require manufacturers of medicines to notify appropriate health authorities of adverse event reports. Authorities inspect manufacturers periodically to ensure their obligations are met.


What types of information are collected by pharmacovigilance?

When medicines come onto the market, there can be limited information about their safety, based primarily on clinical trials. All medicines have risks as well as benefits and the Pharmacovigilance department plays an important role by continuously evaluating information received from patients, healthcare professionals and members of the public in balancing benefits against risk.

Some of the information collected includes:

  • Side effects to medicines
  • Use of medicines during pregnancy and breastfeeding
  • Abnormal laboratory findings
  • Occupational exposure to medicines
  • Overdose, misuse of medicine
  • Product complaints
  • Counterfeit products
  • Unexpected benefit from a medicine
  • Lack of effectiveness
  • Death while using a medicine
  • Interactions between medicines and between medicines and food
  • Using a medicine outside of its intended use
  • Medication errors

Reporting adverse events information

If you are worried about your health while taking a medicine, always talk to your doctor, pharmacist or nurse first.

Always read the Patient Information Leaflet, or instruction supplied with your medicine. It lists the known side effects or problems and advises you on what to do.

You can report adverse events to your doctor, nurse or pharmacist. The details on how to do this will be described in the Patient Information Leaflet or instructions supplied with your medicine.

You may also want to report your adverse event to the manufacturer of your medicine. If you would like to report any side effects that you have experienced with an Ipsen medicine, please contact Ipsen Medical Information team on +44 (0)1753 627777 or by email pharmacovigilance.uk-ie@ipsen.com.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to the Ipsen Medical Information Department on 01753627777 or pharmacovigilance.uk-ie@ipsen.com

Date of preparation: June 2021

© Ipsen Group 2021