Combivir

Authorised

Human

Details

EMA number	EMEA/H/C/000190
ATC code	J05AR01
Authorisation	18 March 1998
Revision	37

EMA page

Therapeutic indication

Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

MeSH: HIV Infections

Group: Antivirals for systemic use

Active substances

lamivudine zidovudine

Marketing Authorisation Holder

ViiV Healthcare B.V.

MAH

🇺🇸 Also approved in the US (FDA)

LAMIVUDINE AND ZIDOVUDINE — MACLEODS PHARMS LTD, approved 2019-12-13 (ANDA090679).

Most reported adverse events (US / FAERS)

28,817 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.

foetal exposure during pregnancy

2,773

virologic failure

2,139

pain

2,112

drug interaction

2,077

Timeline

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Combivir authorised

18 Mar 1998

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

LAMIVUDINE AND ZIDOVUDINE — MACLEODS PHARMS LTD, approved 2019-12-13 (ANDA090679).

Most reported adverse events (US / FAERS)

28,817 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.

foetal exposure during pregnancy

2,773

virologic failure

2,139

pain

2,112

drug interaction

2,077

drug resistance

2,040

pathogen resistance

1,943

anxiety

1,941

product dose omission issue

1,915

viral mutation identified

1,858

depression

1,798

drug exposure during pregnancy

1,705

pyrexia

1,679

nausea

1,675

emotional distress

1,618

anaemia

1,544