Reason for request

Extension of indication

No clinical benefit demonstrated by comparison with TEGELINE and PRIVIGEN in chronic inflammatory demyelinating polyradiculoneuropathy

 

  • OCTAGAM, human immunoglobulin for intravenous administration, now has Marketing Authorisation in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

  • There was no proven clinical advantage compared with TEGELINE and PRIVIGEN. Its role in the therapeutic strategy is similar to that of these other immunoglobulins. 

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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Évaluation des médicaments