Zaltrap

Authorised

Human

Details

EMA number	EMEA/H/C/002532
ATC code	L01XX44
Authorisation	1 February 2013
Revision	15

EMA page

Therapeutic indication

Treatment of metastatic colorectal cancer (MCRC).

MeSH: Colorectal Neoplasms

Group: Antineoplastic agents

Active substances

aflibercept

Marketing Authorisation Holder

Sanofi Winthrop Industrie

MAH

🇺🇸 Also approved in the US (FDA)

PAVBLU — AMGEN INC, approved 2026-04-28 (BLA761298).

Most reported adverse events (US / FAERS)

25,247 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

7,928

visual impairment

2,094

off label use

1,620

blindness

1,471

Timeline

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Zaltrap authorised

1 Feb 2013

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

PAVBLU — AMGEN INC, approved 2026-04-28 (BLA761298).

Most reported adverse events (US / FAERS)

25,247 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

7,928

visual impairment

2,094

off label use

1,620

blindness

1,471

endophthalmitis

1,405

visual acuity reduced

1,269

eye pain

1,216

drug ineffective

1,199

vision blurred

1,195

product dose omission issue

1,125

blindness unilateral

1,081

blindness transient

1,037

eye inflammation

998

eye haemorrhage

817

vitreous floaters

792