Neofordex

Application withdrawn

Human

Details

EMA number	EMEA/H/C/002418
ATC code	H02AB02
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of symptomatic multiple myeloma

MeSH: Multiple Myeloma

Active substances

dexamethasone

Marketing Authorisation Holder

THERAVIA

MAH

Laboratoires CTRS - Boulogne Billancourt

MAH

🇺🇸 Also approved in the US (FDA)

DEXAMETHASONE SODIUM PHOSPHATE — MYLAN LABS LTD, approved 2024-06-05 (ANDA040803).

Most reported adverse events (US / FAERS)

199,283 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

23,153

fatigue

17,412

diarrhoea

17,284

nausea

14,426

Timeline

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Neofordex authorised

16 Mar 2016

authorisedregulatory

Status changed: Authorised → Application withdrawn

20 Nov 2014

status_changedregulatory

🇺🇸 Also approved in the US (FDA)

DEXAMETHASONE SODIUM PHOSPHATE — MYLAN LABS LTD, approved 2024-06-05 (ANDA040803).

Most reported adverse events (US / FAERS)

199,283 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

23,153

fatigue

17,412

diarrhoea

17,284

nausea

14,426

plasma cell myeloma

14,108

pneumonia

13,902

death

13,581

drug ineffective

13,406

neutropenia

11,718

pyrexia

11,401

thrombocytopenia

10,723

dyspnoea

10,565

anaemia

9,322

febrile neutropenia

9,181

vomiting

9,101