Information for physician

Thank you for your interest in participating in this registry. Before you continue and enter your patient’s data, 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 a voluntary prospective program designed to collect and evaluate medical information on pregnancies and outcomes reported, following exposure to a pharmaceutical product. Since there is little data regarding pregnancies exposed to ulipristal 30 mg, the collection of further data has been requested by European Health Authorities to continuously monitor the safety profile of ulipristal during pregnancy. The aforementioned companies established this registry to collect information on any pregnancy exposed to ulipristal 30 mg, e.g. unrecognized pregnancy before intake, or treatment failure.

It is important to know that your identity and the identity of your patient will remain strictly confidential and the personal/professional information will only be known to the electronic system. 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 in the online questionnaire.

The registry coordinator (DADA Consultancy B.V.) manages the electronic system and will have access to your personal/professional 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.

Why have I been approached about this registry?

If you have been contacted either via the electronic system based on information provided by a pregnant woman that has been exposed to ulipristal and is your patient, the woman in question has provided us with your contact details and has given her consent for us to request follow-up data on her pregnancy directly from you.

How is patient's confidentiality ensured?

The pregnancy registry will only collect patients' initials, dates of birth and email addresses that will allow the electronic system to link data originating from the same patient. Patients' identities will not be forwarded to pharmaceutical companies. Information on how your and your patient`s data is being processed and protected can be found in the registry data privacy policy: Click here for privacy policy

Entering data on behalf of your patient

Please note that patients are not required to sign an Informed Consent Form attesting they accept their data to be collected in the framework of this registry. However, before enrolment in the registry, you should inform each patient of the objective and the content of the registry. Patients should be reassured that any information used would be handled in an anonymous manner in order to preserve confidentiality.

If you are a healthcare professional and intend to report a patient’s pregnancy after exposure to Ullanesse Filmtabletten bought in Switzerland, please contact pharmacovigilance@spirig-healthcare.ch for directions before submitting data to the registry.

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