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ROTOP-nanoHSA (99mTc-labelled human albumin nanocolloid), radiopharmaceutical agent
DIAGNOSTIC MEDICINAL PRODUCT - Update
Opinions on drugs -
Posted on
Jun 01 2015
Reason for request
Inclusion
No diagnostic benefit demonstrated by comparison with current diagnostic agents (NANOCIS, NANOCOLL) used in whole-body lymphoscintigraphy and sentinel lymph node detection
- ROTOP-nanoHSA has Marketing Authorisation:- in lymphoscintigraphy for visualisation of the lymphatic system and to differentiate between venous and lymphatic obstruction.- in lymphoscintigraphy for the detection of sentinel lymph nodes in malignant melanoma and breast cancer.
- 99mTc-labelled albumin nanocolloids have been used for several years in the two indications of the Marketing Authorisation.
- No comparative study is available versus technetium (99mTc)-labelled rhenium sulfide nanocolloids (NANOCIS), or by comparison with any other proprietary medicinal product based on technetium (99mTc)-labelled albumin nanocolloids (NANOCOLL).
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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