Beromun

RSS

tasonermin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 11/01/2022

Authorisation details

Product details
Name
Beromun
Agency product number
EMEA/H/C/000206
Active substance
tasonermin
International non-proprietary name (INN) or common name
tasonermin
Therapeutic area (MeSH)
Sarcoma
Anatomical therapeutic chemical (ATC) code
L03AX11
Publication details
Marketing-authorisation holder
Belpharma s.a.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
12/04/1999
Contact address

2, Rue Albert 1 er
L-1117 Luxembourg
Luxembourg

Product information

09/12/2021 Beromun - EMEA/H/C/000206 - IB/0057

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

Immunostimulants

Therapeutic indication

Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP).

Assessment history

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