Viekirax

WithdrawnHuman

Details

EMA number	EMEA/H/C/003839
ATC code	J05AP53
Authorisation	14 January 2015
Withdrawn	25 September 2024
Revision	28

EMA page

Therapeutic indication

Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. For hepatitis C virus (HCV) genotype specific activity.

MeSH: Hepatitis C, Chronic

Group: Antivirals for systemic use

Active substances

ritonavir ombitasvir paritaprevir

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

MAH

🇺🇸 Also approved in the US (FDA)

NORVIR — ABBVIE, approved 2026-07-23 (NDA209512).

Most reported adverse events (US / FAERS)

90,405 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.

covid-19

22,994

disease recurrence

20,164

dysgeusia

7,499

diarrhoea

5,699

drug interaction

Timeline

Filter by authority:

Viekirax withdrawn

25 Sept 2024

withdrawnregulatory

Viekirax authorised

14 Jan 2015

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

NORVIR — ABBVIE, approved 2026-07-23 (NDA209512).

Most reported adverse events (US / FAERS)

90,405 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.

covid-19

22,994

disease recurrence

20,164

dysgeusia

7,499

diarrhoea

5,699

drug interaction

5,063

nausea

4,344

fatigue

3,161

pain

2,999

foetal exposure during pregnancy

2,989

headache

2,946

vomiting

2,798

off label use

2,625

pyrexia

2,560

cough

2,350

anxiety

2,214