F
Hi,
I am trying to figure out what Combination Products are approved in the EU.
The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices, and viable cells or tissues, or non-viable cells or tissues where the action on the human body of these cells or tissues is primary to the device." e.g. a drug eluting stent.
I have found the examples of combination products approved by the FDA for the U.S. market in this site: Examples of Combination Product Approvals
But I cannot find the European equivalent site.
Can anyone help me with this, please?
Cheers, F.
I am trying to figure out what Combination Products are approved in the EU.
The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices, and viable cells or tissues, or non-viable cells or tissues where the action on the human body of these cells or tissues is primary to the device." e.g. a drug eluting stent.
I have found the examples of combination products approved by the FDA for the U.S. market in this site: Examples of Combination Product Approvals
But I cannot find the European equivalent site.
Can anyone help me with this, please?
Cheers, F.