Susvimo

Application withdrawn

Human

Details

EMA number	EMEA/H/C/005610
ATC code	S01LA04
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of neovascular age-related macular degeneration in adults.

MeSH: Wet Macular Degeneration

Group: ranibizumab

Active substances

ranibizumab

Marketing Authorisation Holder

Roche Registration GmbH

MAH

🇺🇸 Also approved in the US (FDA)

CIMERLI — SANDOZ INC, approved 2024-05-21 (BLA761165).

Most reported adverse events (US / FAERS)

20,521 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.

death

3,809

visual acuity reduced

2,892

off label use

1,703

visual impairment

1,635

Timeline

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Status changed: Opinion → Application withdrawn

18 Jul 2023

status_changedregulatory

🇺🇸 Also approved in the US (FDA)

CIMERLI — SANDOZ INC, approved 2024-05-21 (BLA761165).

Most reported adverse events (US / FAERS)

20,521 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.

death

3,809

visual acuity reduced

2,892

off label use

1,703

visual impairment

1,635

cerebrovascular accident

1,237

drug ineffective

1,210

blindness

1,048

eye haemorrhage

1,046

no adverse event

1,045

vision blurred

1,035

eye pain

960

retinal haemorrhage

795

endophthalmitis

734

myocardial infarction

689

cataract

683