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Portugal INFARMED · Portugal · Approval & opinion

Alhemo (Concizumab) – Public funding evaluation report available; positive preliminary assessment decision

Original title: Alhemo (Concizumab) | Relatório de avaliação de financiamento público disponível na Infomed | Deferimento do pedido de avaliação prévia

AI-generated summary

Alhemo (Concizumab) has received authorization for hospital use to prevent routine bleeding in patients aged 12 and older with severe hemophilia A without factor VIII inhibitors or moderate/severe hemophilia B without factor IX inhibitors. Portugal's INFARMED has approved a prior assessment request and made a public funding evaluation report available.

Dates and deadlines
Applies from
28 Sep 2026
Regulatory deadline
28 Sep 2026
From Portugal INFARMED

O medicamento Alhemo (Concizumab) obteve autorização para ser utilizado em meio hospitalar na indicação: profilaxia de rotina de hemorragia em doentes com idade igual ou superior a 12 anos com:

- hemofilia A grave (deficiência congénita de fator VIII, FVIII < 1%) sem inibidores do FVIII.

- hemofilia B moderada/grave (deficiência congénita de fator IX, FIX ≤ 2%) sem inibidores do FIX.

Excerpt from the official page. The original is authoritative.