NEVDK schreef op 19 oktober 2018 14:13:
The CHMP recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.
INN lanadelumab
Marketing-authorisation applicant Shire Pharmaceuticals Ireland Limited
Therapeutic indication
Treatment of angioedema attacks, prevention of angioedema attacks
More information New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
List item
CHMP summary of positive opinion for Takhzyro (PDF/71.66 KB)
Adopted
First published: 19/10/2018
EMA/700432/2018
de kaas wordt van tussen de boterham gegeten....