ellaOne® Pregnancy Registry | HRA Pharma
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What is a Pregnancy 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.

What is ellaOne®?

ellaOne® is a female emergency contraceptive to be taken within five days of unprotected sex or contraceptive failure (such as a tear in a condom during sex).

What is the aim of the ellaOne® Pregnancy Registry?

Since there is little data regarding pregnancies exposed to ellaOne®, the collection of further data is needed to continuously monitor the safety profile of ellaOne® during its commercialization. In agreement with the European Medicines Agency, HRA Pharma has decided to establish this registry to collect information on any pregnancy exposed to ellaOne®, e.g. unrecognized pregnancy before intake or treatment failure.

Why should you advise your patient to participate in this pregnancy registry?

By participating in this pregnancy registry, the medical information provided by your patients will contribute to the collection of valuable information. The data collected will be analyzed and may be used to update the pregnancy section of the Summary of Product Characteristics of ellaOne® as appropriate.

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.

Your patient may also complete the questionnaire on her own. You can print and hand out a document to all ellaOne® users to inform them about the existence of the pregnancy registry. In case a pregnancy exposed to ellaOne® occurs, the patient is aware of the pregnancy registry and can participate via direct access through the pregnancy registry website. The patient can participate in the pregnancy registry on her own.

Click here to download information on the pregnancy registry to be given to your patient.

How is patient's confidentiality ensured?

Patients' and babies' identities will not be collected. The pregnancy registry will only collect patients' initials and dates of birth that will allow HRA Pharma to obtain information on a patient correctly identified when contacting health care professionals. Information on initials and date of birth are only asked for to facilitate the follow-up of the pregnancies. The information collected in the registry will not be sufficient to identify patients.

How can you participate?

When you are advised that one of your patients has been inadvertently exposed to ellaOne® during her pregnancy or has become pregnant despite having taken ellaOne® following unprotected intercourse, you are encouraged to report prenatal exposure to ellaOne® during pregnancy by completing the Enrolment form as early as possible to facilitate the collection of prospective and unbiased information.

Once you will know the final details relating to the outcome of your patient's pregnancy, we would be grateful if you could further complete the Pregnancy Outcome form, which can be found on the ellaOne® Pregnancy Register website.

To register a new patient in the registry OR to further report the pregnancy outcome of a patient you have already registered, click here !

Warning : no follow-up reporting can be done without the patient file number sent by mail.

How can you get more information on the pregnancy registry?

You can obtain further information about the pregnancy registry by contacting HRA Pharma:

Fax: + 33 1 42 77 03 52

Email: pharmacovigilance@hra-pharma.com

The success of the registry depends only on your participation.
Thank you in advance for your active support!

HRA Pharma does not recommend the use of ellaOne® in any manner other than as described in the
Summary of Product Characteristics