Bekemv is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH), a disease in which excessive breakdown of blood cells results in anaemia (low levels of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine. Bekemv is a ‘biosimilar medicine’. This means that Bekemv is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Bekemv is Soliris. For more information on biosimilar medicines, see [here](/en/biosimilar-medicines-overview). Bekemv contains the active substance eculizumab.
Therapeutic Indication
Bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5\.1\).
Therapeutic Area (MeSH)
ATC Code
L04AJ01
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Eculizumab | N/A | Eculizumab |
EMA Name
Bekemv
Medicine Name
Bekemv
Aliases
N/ANo risk management plan link.
