Crixivan Merck Sharp & Dohme B.V. · Withdrawn · authorised 4 Oct 1996 · ATC J05AE02
Therapeutic indication (EMA)
Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.
Active substance
Indinavir
- US FDA 1
- EMA 1
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CRIXIVAN | EQ 400MG BASE; EQ 200MG BASE; EQ 333MG BASE; EQ 100MG BASE | capsule · oral | MERCK SHARP DOHME | Discontinued | 13 Mar 1996 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes - EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No - US FDA 15 Sep 2016 CRIXIVAN — safety-related labeling change
Labeling sections changed: Contraindications; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.