Balaxur

Refused

Human

Details

EMA number	EMEA/H/C/002708
ATC code	N06DA52
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Alzheimer Disease

Active substances

memantine hydrochloride donepezil hydrochloride

Marketing Authorisation Holder

Merz Pharmaceuticals GmbH

MAH

🇺🇸 Also approved in the US (FDA)

MEMANTINE HYDROCHLORIDE — ZYDUS LIFESCIENCES, approved 2019-06-28 (ANDA090961).

Most reported adverse events (US / FAERS)

9,353 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.

fall

1,003

death

945

drug ineffective

878

off label use

784

🇺🇸 Also approved in the US (FDA)

MEMANTINE HYDROCHLORIDE — ZYDUS LIFESCIENCES, approved 2019-06-28 (ANDA090961).

Most reported adverse events (US / FAERS)

9,353 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.

fall

1,003

death

945

drug ineffective

878

off label use

784

confusional state

764

fatigue

658

hallucination

643

condition aggravated

530

dizziness

508

asthenia

495

somnolence

464

nausea

444

urinary tract infection

442

diarrhoea

426

product dose omission issue

369