Posatex

AuthorisedVeterinary

Details

EMA number	EMEA/V/C/000122
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

Active substances

posaconazole mometasone furoate orbifloxacin

🇺🇸 Also approved in the US (FDA)

POSACONAZOLE — HIKMA, approved 2024-10-24 (ANDA208773).

Most reported adverse events (US / FAERS)

12,049 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.

off label use

1,593

drug ineffective

1,457

febrile neutropenia

1,039

product use in unapproved indication

977

🇺🇸 Also approved in the US (FDA)

POSACONAZOLE — HIKMA, approved 2024-10-24 (ANDA208773).

Most reported adverse events (US / FAERS)

12,049 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.

off label use

1,593

drug ineffective

1,457

febrile neutropenia

1,039

product use in unapproved indication

977

death

958

drug interaction

952

pyrexia

870

neutropenia

724

pneumonia

664

thrombocytopenia

515

diarrhoea

507

nausea

492

septic shock

450

condition aggravated

432

acute kidney injury

419