OCTAPLASLG (human plasma proteins), medicinal product derived from blood

TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on Dec 07 2017

Reason for request

Inclusion

No clinical benefit demonstrated when compared with currently available normal plasmas.

 

  • OCTAPLASLG is the first plasma with Marketing Authorisation in France in the treatment of complex coagulation factor deficiencies, substitution therapy in coagulation factor deficiencies, potentially dangerous haemorrhages during fibrinolytic therapy, therapeutic plasma exchange procedures and rapid reversal of the effects of oral anticoagulants (coumarin or indanedione).
  • It is a fresh-frozen plasma (FFP) differentiated according to the blood group (A, B and O), obtained from a large mixture of donations of blood of the same group and solvent/detergent-inactivated with additional stages with a view to minimising allergic, immunological and infectious risks.
  • There has been no convincing demonstration of superiority with regard to these various risks (potential risk as regards the prion risk) in comparison to normal plasma.
  • Like other plasmas, it is a first-line product in its indications.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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