Information for women entering data themselves

Thank you for your interest in participating in this registry. Before you continue, it is important for you to understand why this registry was set-up and what participation means for you.

Who is responsible for the creation of this registry?

This joint pregnancy registry is set-up on request of the European Health Authorities by the following pharmaceutical companies as joint data controllers:
  • Aristo Pharma GmbH
  • Aspen Healthcare Malta Limited
  • BIOGARAN
  • ELPEN Pharmaceutical Co. Inc
  • Exeltis Pharmaceuticals Holding, S.L.
  • Farmitalia s.r.l
  • HELM AG
  • Mylan
  • Hexal AG
  • STADA Arzneimittel AG
  • Zentiva Group, a.s.

What is a pregnancy registry and what is the purpose of this registry?

A pregnancy registry is an important program aimed at collecting medical information on women exposed to a pharmaceutical product during their pregnancy. The information collected from the pregnancy registry will allow to gain more information on exposure to ulipristal 30 mg during pregnancy. In the long term, other pregnant women could therefore benefit from your participation and the data collected via this registry. Your information shall only be used for these scientific research purposes.

Disclaimer

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.

It is important to know that your identity will remain strictly confidential

Personal data limited to your initials, your email address and date of birth are collected to allow the electronic system to link data reported on the same pregnancy. Your personal data will be encrypted by the system in such a way that your identity will not be known to any of the pharmaceutical companies.

Your email address will also be requested and will be used only within the electronic system, through which you will receive automated emails that will allow you to complete additional information on the course and outcome of your pregnancy in the online questionnaire.

If you bought Ullanesse Filmtabletten in Switzerland and intend to report your pregnancy after taking Ullanesse Filmtabletten, please do not submit your data directly to the registry, but ask your doctor to contact pharmacovigilance@spirig-healthcare.ch.

If you have also agreed to provide your physician’s contact details, he or she will be contacted via the electronic system. By providing the contact details of your physician, you are authorizing us to contact your physician and you authorize your physician to provide further information on your pregnancy and its outcome.

The registry coordinator (DADA Consultancy B.V.) manages the electronic system and will have access to your personal and medical information. However, the information will only be used for the correct handling and linking of data in the electronic system and will remain strictly confidential.

Information on how your data is being processed and protected can be found in the registry data privacy policy: Privacy policy

You have to download and read the privacy policy before you can participate