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Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg

NAFDAC Reg. No. A4-100333 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg
NAFDAC number
A4-100333
Active ingredient
Emtricitabine; Tenofovir Disoproxil Fumarate
Strength
200 mg; 300 mg
Form
Tablet
Pack size
1 x 30's (in HDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Onifam Laboratories Limited
Approved
23 Feb 2023
Status
Active View on NAFDAC ↗
Registration valid to
22 Feb 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg is on the NAFDAC register with an active registration (A4-100333). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg is used for

From the official U.S. FDA label for emtricitabine, the active ingredient registered with NAFDAC.

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 e mtricitabine. 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 emtricitabine. …
What it is used for

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

Possible 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 [see Warnings and Precautions ( 5.1 )] . Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.2 )] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions ( 5.3 )] . 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. …

Do not use if

Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. ( 4 )

Warnings

Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.2 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.3 ) 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when initiating emtricitabine [see Dosage and Administration ( 2.1 )]. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg

What is in Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg?

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg contains Emtricitabine; Tenofovir Disoproxil Fumarate (200 mg; 300 mg), as tablet, according to its NAFDAC registration record.

Is Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg registered with NAFDAC?

Yes. Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg is listed on the NAFDAC register under registration number A4-100333, and its registration is active as of 6 November 2026.

Has Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg in our automatically synced alert list.

How can I check that my pack of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg is genuine?

Run a free authenticity scan with the NAFDAC number A4-100333, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 and 300 mg used for?

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 ) (Summarised from the official U.S. FDA label for emtricitabine. Always follow your doctor or pharmacist.)

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