Orblid

Application withdrawnHuman

Orphan medicine

Details

EMA number	EMEA/H/C/006392
ATC code	L01FG01
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of adult patients with hereditary haemorrhagic telangiectasia

MeSH: Telangiectasia, Hereditary Hemorrhagic

Group: Antineoplastic agents;monoclonal antibodies and antibody drug conjugates

Active substances

bevacizumab

Marketing Authorisation Holder

Laboratoires Delbert

MAH

🇺🇸 Also approved in the US (FDA)

JOBEVNE — BIOCON BIOLOGICS INC, approved 2025-04-09 (BLA761175).

Most reported adverse events (US / FAERS)

93,213 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

off label use

14,595

death

13,344

disease progression

7,475

diarrhoea

7,364

🇺🇸 Also approved in the US (FDA)

JOBEVNE — BIOCON BIOLOGICS INC, approved 2025-04-09 (BLA761175).

Most reported adverse events (US / FAERS)

93,213 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

off label use

14,595

death

13,344

disease progression

7,475

diarrhoea

7,364

nausea

6,557

fatigue

6,473

hypertension

6,034

vomiting

4,992

anaemia

4,399

pyrexia

4,061

neutropenia

4,016

asthenia

3,609

decreased appetite

3,472

dyspnoea

3,454

thrombocytopenia

3,368