News
IASOcholine: New authorization in Germany and Austria!
We are happy to announce that from now on our product IASOcholine® is also available for the German and Austrian market.
On the 19th of July 2011 IASOcholine® was registered as a pharmaceutical in Germany with the authorization number 81779.00.00 and on the 25th of August 2011 in Austria with the authorization number 4-00044.
In France IASOcholine® has already been registered since the 2nd of April 2010.
What is IASOcholine® and when is it applied?
IASOcholine® is a radioactive pharmaceutical for diagnostic use only. It is a diagnostic for the positron emission tomography (PET) and is administered prior to such an examination. The active ingredient in IASOcholine® allows to picture an enhanced influx of the natural substance choline in specific organs or tissues and is detected by PET and shown as a picture.
IASOcholine® is administered by single intravenous injection.
This examination is carried out to help decide on how to treat the illness you are suffering from or you are suspected of suffering from.
The following indications for PET with fluorocholine (18F) have been particularly documented:
Prostate cancer
- Detection of bone metastases of prostate cancer in high risk patients.
Hepatocellular carcinoma
- Localisation of lesions of proven well-differentiated hepatocellular carcinoma
- In addition to FDG PET, characterisation of liver nodes and/or staging of proven or very likely hepatocellular carcinoma, when FDG PET is non conclusive or when surgery or grafting is scheduled.
You can find the valid SPCs of the respective countries with marketing authorization here on our homepage under: Products - Radiopharmaceuticals - IASOcholine, or directly under Downloads - SPCs.
For the following countries the Mutual Recognition Procedure has been finished successfully, the authorization documents being expected to arrive within the next weeks: Poland and Slovenia.
