Dimherity

Application withdrawnHuman

Details

EMA number	EMEA/H/C/006042
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of multiple sclerosis.

MeSH: Multiple Sclerosis, Relapsing-Remitting

Group: Immunosuppressants

Active substances

dimethyl fumarate

Marketing Authorisation Holder

Sandoz GmbH

MAH

🇺🇸 Also approved in the US (FDA)

DIMETHYL FUMARATE — HETERO LABS LTD III, approved 2020-09-24 (ANDA210500).

Most reported adverse events (US / FAERS)

102,225 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.

flushing

17,084

nausea

8,965

diarrhoea

8,285

multiple sclerosis relapse

8,097

🇺🇸 Also approved in the US (FDA)

DIMETHYL FUMARATE — HETERO LABS LTD III, approved 2020-09-24 (ANDA210500).

Most reported adverse events (US / FAERS)

102,225 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.

flushing

17,084

nausea

8,965

diarrhoea

8,285

multiple sclerosis relapse

8,097

fatigue

6,952

multiple sclerosis

5,723

vomiting

5,647

memory impairment

5,565

gastric disorder

5,551

abdominal pain upper

5,407

drug ineffective

5,215

pruritus

5,061

headache

5,034

fall

5,019

gait disturbance

4,620