Product

IASOcholine

choline header

Marketing Authorizations

Country
Product Name
MA number
Date of registration
PDF
PDF
France
IASOcholine
34009 578 253 3 1 (15mL) 34009 576 946 1 6 (25mL)
02.04.2015
Austria
IASOcholine
4-00044
25.08.2011
Belgium
IASOcholine
BE 440 176 (15mL) BE 440 185 (25mL)
08.07.2013
No data was found
No data was found
No data was found
Bulgaria
IASOcholine
II-19591/20.09.12
20.09.2012
No data was found
Czech Republic
IASOcholine
88/651/12-C
14.11.2012
No data was found
Estonia
IASOcholine
792812
29.08.2012
Germany
IASOcholine
81779.00.00
19.07.2011
No data was found
No data was found
Italy
Pcolina
043096015 (13mL) 043096027 (15mL)
03.02.2014
Lithuania
Pcolina
LT/1/12/3159/001 (15mL) LT/1/12/3159/002 (25mL)
17.12.2012
Luxemburg
IASOcholine
2013080285
01.08.2013
Malta
IASOcholine
MA986/00101
26.04.2013
No data was found
Poland
IASOcholine
20446
31.07.2012
No data was found
Romania
IASOcholine
8391/2015/01-02
17.10.2012
Slovakia
IASOcholine
88/0527/12-S
05.12.2012
Slowenia
IASOcholine
H/12/00746/001 (15mL) H/12/00746/002 (25mL)
11.07.2012

Product sheets

Name
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Pcolina
IASOcholine

Fluorocholine (¹⁸F) Chloride is indicated for use with Positron Emission tomography (PET).

IASOcholine is used for imaging in patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced choline influx of specific organs or tissues is the diagnostic target.

The following indications for PET with fluorocholine (18F) Chloride have been sufficiently 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
    This medicinal product is for diagnostic use only.

Therapeutic indications. This medicinal product is for diagnostic use only.

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