- Date 06 December 2017
- Documents : 3
- History
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CLAIRYG, human immunoglobulin
NEUROLOGY - New indication
Opinions on drugs -
Posted on
Mar 29 2018
Reason for request
Extension of indication
Substantial clinical benefit in the treatment of chronic inflammatory demyelinating polyneuropathy, but no clinical benefit demonstrated compared with immunoglobulins (OCTAGAM, TEGELINE and PRIVIGEN)
- CLAIRYG already has Marketing Authorisation in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
- The Marketing Authorisation in this indication was obtained based on the results (descriptive only) of a phase III study comparing CLAIRYG and TEGELINE.
- The use of immunoglobulin administered intravenously (IVIGs) is well documented in the treatment of CIDP. The role of CLAIRYG in the therapeutic strategy is similar to that of these other immunoglobulins.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
-
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