Subscribe to
our newsletters

Subscribe to our newsletters!

Subscribe to our newsletter and get the latest news from the Nordics straight to your inbox.

Search in Nordic Life Science Insight

-
September 13, 2017
Spago Nanomedical

FDA votes for further warnings for gadolinium-based contrast agents

In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others.

FDA votes for further warnings for gadolinium-based contrast agents

In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others.

-
Spago Nanomedical
-
September 13, 2017

In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others. The decision is based on a scientific review by the EMA Pharmacovigilance Risk Assessment Committee, PRAC, which concludes that gadolinium may accumulate in the brain and other tissues after using gadolinium-containing contrast agents.

After taking a “wait and see”-attitude, the US food and drug administration FDA is now expected to take further regulatory measures regarding the use of gadolinium-based contrast agents. The FDA Medical Imaging Drugs Advisory Committee, MIDAC, voted on September 8th for the FDA to include warnings for gadolinium retention in certain tissues to the labels of gadolinium-based contrast agents. In addition, MIDAC voted with overwhelming majority to have the FDA require that manufacturers of gadolinium-based contrast agents carry out clinical trials to determine whether additional regulatory measures are required, including withdrawal of market authorisation or restrictions of use in certain populations.

Spago Nanomedical’s contrast agent for MRI, SpagoPix, is gadolinium-free.

Link to EMA descision

About the FDA attitue  (Aunt Minnie.com/MRI)

Last updated:
September 13, 2017

Spago Nanomedical

Spago Nanomedical AB is a Swedish company performing research and development within nanomedicine. Focus is the development of nanomaterials for tumor diagnostics and treatment of cancer. The main development projects SpagoPix and Tumorad are both built on proprietary nanomaterials

Click here to read more about us!
Get in touch with us!
Visit us

Scheelevägen 22
SE-223 63 Lund
Sweden

Send us mail

In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others. The decision is based on a scientific review by the EMA Pharmacovigilance Risk Assessment Committee, PRAC, which concludes that gadolinium may accumulate in the brain and other tissues after using gadolinium-containing contrast agents.

After taking a “wait and see”-attitude, the US food and drug administration FDA is now expected to take further regulatory measures regarding the use of gadolinium-based contrast agents. The FDA Medical Imaging Drugs Advisory Committee, MIDAC, voted on September 8th for the FDA to include warnings for gadolinium retention in certain tissues to the labels of gadolinium-based contrast agents. In addition, MIDAC voted with overwhelming majority to have the FDA require that manufacturers of gadolinium-based contrast agents carry out clinical trials to determine whether additional regulatory measures are required, including withdrawal of market authorisation or restrictions of use in certain populations.

Spago Nanomedical’s contrast agent for MRI, SpagoPix, is gadolinium-free.

Link to EMA descision

About the FDA attitue  (Aunt Minnie.com/MRI)

Last updated:
September 13, 2017

Spago Nanomedical

Spago Nanomedical AB is a Swedish company performing research and development within nanomedicine. Focus is the development of nanomaterials for tumor diagnostics and treatment of cancer. The main development projects SpagoPix and Tumorad are both built on proprietary nanomaterials

Click here to read more about us!
Get in touch with us!
Visit us

Scheelevägen 22
SE-223 63 Lund
Sweden

Send us mail