Bosatria

Application withdrawnHuman

Orphan medicine

Details

EMA number	EMEA/H/C/001069
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Hypereosinophilic Syndrome

Active substances

Mepolizumab

Marketing Authorisation Holder

Glaxo Group Limited

MAH

🇺🇸 Also approved in the US (FDA)

NUCALA — GLAXOSMITHKLINE, approved 2025-08-06 (BLA761122).

Most reported adverse events (US / FAERS)

76,911 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.

asthma

12,635

dyspnoea

10,418

wheezing

7,036

product dose omission issue

6,427

🇺🇸 Also approved in the US (FDA)

NUCALA — GLAXOSMITHKLINE, approved 2025-08-06 (BLA761122).

Most reported adverse events (US / FAERS)

76,911 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.

asthma

12,635

dyspnoea

10,418

wheezing

7,036

product dose omission issue

6,427

cough

5,038

therapeutic product effect incomplete

5,004

pneumonia

4,535

drug ineffective

4,521

loss of personal independence in daily activities

4,206

sleep disorder due to a general medical condition

3,090

off label use

3,004

fatigue

2,998

malaise

2,710

condition aggravated

2,670

headache

2,619