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Molecule

Emtricitabine

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Available on requestCold chainHepatitis B and CHIV
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Emtricitabine is a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is available as capsules and oral solution. MedsAcross supplies Emtricitabine 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
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitors
ATC classification
J05AF09 Emtricitabine · Direct acting antiviral, subgroup J05AF
US FDA first approval
2 July 2003
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule, Oral solution
Identifiers
UNII G70B4ETF4SRxCUI 276237CAS 143491-57-0DrugBank DB00879Q422604

Clinical information

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

Uses

EMTRIVA ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. EMTRIVA, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Source: US FDA prescribing information

Dosing overview

Testing: Prior to or when initiating EMTRIVA test for hepatitis B virus infection. EMTRIVA may be taken without regard to food. Adult Patients (18 years of age and older): EMTRIVA capsules: One 200 mg capsule administered once daily orally. EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally. Pediatric Patients (0–3 months of age): EMTRIVA oral solution: 3 mg/kg administered once daily orally. Pediatric Patients (3 months through 17 years of age): EMTRIVA capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally.

Source: US FDA prescribing information

Contraindications

EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (posttreatment acute exacerbation of hepatitis b): Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. Immune reconstitution syndrome: May necessitate further evaluation and treatment. Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV. Immune Reconstitution Syndrome. Lactic Acidosis/Severe Hepatomegaly with Steatosis. Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Skin hyperpigmentation was very common (≥10%) in pediatric patients.

Source: US FDA prescribing information

Interactions

The potential for drug interactions with EMTRIVA has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling.

Source: US FDA prescribing information

Storage

Store EMTRIVA oral solution refrigerated at 2–8 °C (36–46 °F). EMTRIVA oral solution should be used within 3 months if stored by the patient at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °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 Emtricitabine, sorted by availability.

MedicineManufacturerRegisterAvailability
Emtricitabine 200 mg capsuleOralGeneric name—US FDAAvailable on request
Emtriva 10 mg/mL oral solutionOral Cold chainGilead SciencesUS FDAAvailable on request
Emtriva 200 mg capsuleOral Cold chainGilead SciencesUS 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 2 July 2003Drugs@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

Questions and answers

Is Emtricitabine available for export from India?

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

What brand names does Emtricitabine have?

The catalogue lists 1 brand names for Emtricitabine, including Emtriva.

Is Emtricitabine approved by the US FDA?

Yes. The US FDA first approved Emtricitabine on 2 July 2003, according to Drugs@FDA.

Is Emtricitabine authorised in the European Union?

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

Does Emtricitabine need cold chain shipping?

At least one listed presentation of Emtricitabine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Emtricitabine in?

Emtricitabine is classified under ATC code J05AF09 (Emtricitabine).

References

  1. Emtriva prescribing information (Gilead Sciences). U.S. National Library of Medicine, DailyMed. Retrieved 6 November 2026
  2. Emtriva: European public assessment report (EPAR). European Medicines Agency. Retrieved 18 April 2023

Request Emtricitabine for export supply

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