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TEGELINE (normal human immunoglobulin), IV polyvalent human immunoglobulin
HAEMATOLOGY - New indication
Opinions on drugs -
Posted on
Sep 27 2016
Reason for request
Extension of Inclusion
No clinical benefit demonstrated by comparison with plasma exchange in the management of acute flares of myasthenia gravis
- TEGELINE has Marketing Authorisation in the treatment of acute myasthenia gravis flares.
- It is a first-line treatment in the event of signs of severity during an acute myasthenia gravis attack, as an alternative to plasma exchange. The choice between the two treatments depends on their respective contraindications and the patient’s response.
- A phase III study led to choosing the dose of 1 g/kg in this indication.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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