Bekemv
eculizumab
Table of contents
Overview
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.
Bekemv contains the active substance eculizumab.
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Bekemv : EPAR - Medicine Overview (PDF/113.32 KB) (new)
First published: 15/05/2023
EMA/110175/2023 -
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Bekemv : EPAR - Risk management plan summary (PDF/147.51 KB) (new)
First published: 15/05/2023
Authorisation details
Product details | |
---|---|
Name |
Bekemv
|
Agency product number |
EMEA/H/C/005652
|
Active substance |
Eculizumab
|
International non-proprietary name (INN) or common name |
eculizumab
|
Therapeutic area (MeSH) |
Hemoglobinuria, Paroxysmal
|
Anatomical therapeutic chemical (ATC) code |
L04AA25
|
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
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Marketing-authorisation holder |
Amgen Technology (Ireland) UC
|
Date of issue of marketing authorisation valid throughout the European Union |
19/04/2023
|
Contact address |
Pottery Road |
Product information
Bekemv - EMEA/H/C/005652 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
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).