Our Products

Bylvay^® is a registered trademark of Albireo Pharma, Inc., an Ipsen company.

Tazverik^® is a registered trademark of Epizyme, Inc., an Ipsen company.

Onivyde^® is a registered trademark of Ipsen Biopharm Limited.

Somatuline^® Depot is a registered trademark of Ipsen Pharma S.A.

Dysport^® is a registered trademark of Ipsen Biopharm Limited.

Increlex^® is a registered trademark of Ipsen Biopharmaceuticals, Inc.

Ipsen’s vision is to be a leading global biopharmaceutical company focused on innovation and Specialty Care and our mission is to improve patients’ lives through innovative new medicines

Ipsen commits to enable Early Access to patients to Ipsen Products which are not yet approved by local Health Authorities, hence not yet available for prescription, when the Ipsen Product is considered as eligible for Early Access.

What is “Early Access”:

Ipsen defines “Early Access”¹ as access to:

1. Unapproved medicine for the requested indication in the country where the request comes from
2. For life-threatening or serious medical conditions
3. Where there is no satisfactory alternative therapy available for the given medical condition
4. Where there is no alternative option for the patient to participate in an ongoing clinical trial in the given indication
5. Where the medicine has reasonable medical evidence of the positive balance of benefits/risks in the given indication and the medicinal product has started the regulatory process of approval in the US and/or the EU

Early Access can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.

The physician and the patient should discuss the expected benefits, known and potential unknown risks before seeking Early Access to a medicinal product.

In some cases, Ipsen may set up a program designed to provide Early Access to several patients in defined countries.

The list of Ipsen’s Early Access Programs in the United States is available on www.clinicaltrials.gov.

Request for Early Access to an Ipsen Product:

 Who can request Early Access?

Only qualified Physicians can make requests for Early Access to an Ipsen Product once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.

How can the Physician contact Ipsen and make a request?

Physicians can contact Ipsen and send a request for Early Access to: GlobalMedInfo@ipsen.com

What will happen to the request?

When the request is received by Ipsen, Ipsen will send an acknowledgement of receipt of the request within 48 business hours. The request will be assessed by Ipsen medical affairs fairly, as promptly as possible and after a thorough discussion with the Physician as necessary.

The decision will be based on at least the following criteria:

1. The conditions for Early Access are met
2. Patient’s individual medical conditions
3. Ipsen product availability
4. Regulatory and health system environment where the request has come from (e.g. to make sure a Pharmacovigilance structure is in place)

 What will happen if the request is approved? 

If the request for Early Access is approved by Ipsen, the Physician must collect and complete all necessary documents to comply with appropriate rules and regulations – as quickly as possible. Once collected, Ipsen will send the Physician the requested Ipsen Product for Early Access to treat their patient.

The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.

What will happen if the request is not approved?

Ipsen is committed to Early Access but the company cannot guarantee approval and regrets that there are occasions where it is not appropriate for the company to provide Early Access to its medicine or where the request does not fall within the definition of Early Access. In these circumstances we commit to provide a timely response and clear rationale for the decision.

1.  Other terms commonly used: Compassionate Use, Early Access, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-approval access.

Report an adverse event (AE)

If you think you or someone you know has experienced an adverse event related to an Ipsen product or has a product complaint, please contact Ipsen Biopharmaceuticals, Inc., at 1-855-463-5127.  Adverse events may also be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report an adverse event related or product complaint specific to Bylvay®, please contact us by phone: 855-252-4736; email: medinfo@albireopharma.com