Managed Access Program
Grünenthal recognizes that some patients with serious or life-threatening conditions may not be able to participate in a clinical trial and may have exhausted available treatment options. In selected circumstances and where permitted by local regulations, Grünenthal may consider providing access to investigational or non-commercially available medicines through a Managed Access Program.
A request may be considered when:
- The patient has a serious or life-threatening condition
- No satisfactory approved treatment options remain
- The patient cannot participate in an ongoing clinical trial
- The potential benefit outweighs the potential risks based on available evidence
- Access can be provided in compliance with applicable laws and regulations
- Adequate product supply is available
How can a physician submit a request?
Only treating physicians may submit requests on behalf of their patients.
Kindly fill out the request form found here and e-mail it to: CMOOffice@grunenthal.com
Information submitted as part of a Managed Access request will be processed in accordance with the Data Privacy Notice included in the request form.
What happens after submission?
- Grünenthal acknowledges receipt of the request.
- The request undergoes medical, regulatory, safety and feasibility review.
- Decisions are made on a case-by-case basis.
- Approval cannot be guaranteed.
- Additional information may be requested.
Our Principles
Grünenthal is committed to:
- Patient safety
- Ethical access to medicines
- Regulatory compliance
- Scientific integrity
- Fair and consistent evaluation of requests
- Respect to privacy rights
Participation in clinical trials remains the preferred route whenever possible because it allows the generation of data necessary to establish safety and efficacy.