This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 15/05/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Hemoglobinuria, Paroxysmal
Anatomical therapeutic chemical (ATC) code

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
Marketing-authorisation holder
Amgen Technology (Ireland) UC
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Pottery Road
Dun Laoghaire
Co. Dublin

Product information

Bekemv - EMEA/H/C/005652 -

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Product information documents contain:

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


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).

Assessment history

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