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MedsAcross

Molecule

Ritonavir

Cytochrome P450 3A Inhibitor
Available on requestOrphanHIV
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Ritonavir is a cytochrome P450 3A inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, among other approved uses. It is available as tablets and oral powder. MedsAcross supplies Ritonavir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Cytochrome P450 3A Inhibitor, Protease Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 1A2 Inducers, Cytochrome P450 2B6 Inducers, Cytochrome P450 2C19 Inducers, Cytochrome P450 2C9 Inducers, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A Inducers, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, HIV Protease Inhibitors
ATC classification
J05AE03 Ritonavir · Direct acting antiviral, subgroup J05AE
US FDA first approval
1 March 1996
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Oral powder
Identifiers
UNII O3J8G9O825RxCUI 85762CAS 155213-67-5DrugBank DB00503Q422618

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NORVIR tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. NORVIR tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Source: US FDA prescribing information

Dosing overview

Adult patients: 600 mg twice-day with meals. Pediatrics patients: Do not exceed 600 mg twice daily dose with meals for children greater than one month of age. The dose is based on body surface area. Use NORVIR oral powder only for dosing increments of 100 mg. Follow the Instructions for Use for preparation and administration of NORVIR oral powder. Dose modification for NORVIR is necessary when used with other protease inhibitors

Source: US FDA prescribing information

Contraindications

• Consult the prescribing information of the co-administered protease inhibitor for contraindication information for that product. • NORVIR is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (drug-drug interactions leading to potentially serious and/or life threatening reactions): Co-administration of NORVIR with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of NORVIR on the hepatic metabolism of certain drugs. The following have been observed in patients receiving NORVIR: The concomitant use of NORVIR and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. Hepatotoxicity: Fatalities have occurred. Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in greater detail in other sections of the labeling. Drug Interactions Hepatotoxicity Pancreatitis Allergic Reactions/Hypersensitivity When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions. The most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia

Source: US FDA prescribing information

Interactions

When co-administering NORVIR with other protease inhibitors (atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir), see the full prescribing information for that protease inhibitor including important information for drug interactions. Co-administration of NORVIR can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy

Source: US FDA prescribing information

Storage

Storage Store at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Store at or below 30°C (86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Ritonavir, sorted by availability.

MedicineManufacturerRegisterAvailability
Ritonavir 100 mg tabletOralGeneric name—US FDAAvailable on request
Norvir 100 mg tabletOralAbbVieUS FDAAvailable on request
Norvir 100 mg oral powderOralAbbVieUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 1 March 1996Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Ritonavir in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Ritonavir available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Ritonavir and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Ritonavir have?

The catalogue lists 1 brand names for Ritonavir, including Norvir.

Is Ritonavir approved by the US FDA?

Yes. The US FDA first approved Ritonavir on 1 March 1996, according to Drugs@FDA.

Is Ritonavir authorised in the European Union?

Yes. Ritonavir has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Ritonavir need cold chain shipping?

No listed presentation of Ritonavir is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Ritonavir in?

Ritonavir is classified under ATC code J05AE03 (Ritonavir).

References

  1. Norvir prescribing information (AbbVie). U.S. National Library of Medicine, DailyMed. Retrieved 23 July 2026
  2. Norvir: European public assessment report (EPAR). European Medicines Agency. Retrieved 7 January 2026
  3. Ritonavir Viatris (previously Ritonavir Mylan): European public assessment report (EPAR). European Medicines Agency. Retrieved 7 October 2026

Request Ritonavir for export supply

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