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Atazanavir (As Sulfate) And Ritonavir Tablets

NAFDAC Reg. No. B4-0196 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Atazanavir (As Sulfate) And Ritonavir Tablets
NAFDAC number
B4-0196
Active ingredient
Atazanavir; Ritonavir
Strength
300 mg; 100 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Healthline Limited
Approved
10 Nov 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
9 Nov 2025
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Atazanavir (As Sulfate) And Ritonavir Tablets is on the NAFDAC register with an active registration (B4-0196). 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 Atazanavir (As Sulfate) And Ritonavir Tablets is used for

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

What it is used for

REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ] . • Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4) ] . …

Possible side effects

The following adverse reactions are discussed in greater detail in other sections of the labeling: • cardiac conduction abnormalities [see Warnings and Precautions (5.1) ] • rash [see Warnings and Precautions (5.2) ] • hyperbilirubinemia [see Warnings and Precautions (5.8) ] • chronic kidney disease [see Warnings and Precautions (5.5) ] • nephrolithiasis and cholelithiasis [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. …

Do not use if

REYATAZ is contraindicated: • in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of REYATAZ capsules or REYATAZ oral powder [see Warnings and Precautions (5.2) ] . …

Warnings

• Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.1 , 7.3 , 12.2 , 17) • Severe Skin Reactions: Discontinue if severe rash develops. (5.2 , 17) • Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a concomitant transaminase increase occurs, evaluate for alternative etiologies. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to REYATAZ during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Atazanavir has been evaluated in a limited number of women during pregnancy. …

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

Check your pack of Atazanavir (As Sulfate) And Ritonavir Tablets

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 Atazanavir (As Sulfate) And Ritonavir Tablets

What is in Atazanavir (As Sulfate) And Ritonavir Tablets?

Atazanavir (As Sulfate) And Ritonavir Tablets contains Atazanavir; Ritonavir (300 mg; 100 mg), as tablet, according to its NAFDAC registration record.

Is Atazanavir (As Sulfate) And Ritonavir Tablets registered with NAFDAC?

Yes. Atazanavir (As Sulfate) And Ritonavir Tablets is listed on the NAFDAC register under registration number B4-0196, and its registration is active as of 6 November 2026.

Has Atazanavir (As Sulfate) And Ritonavir Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Atazanavir (As Sulfate) And Ritonavir Tablets in our automatically synced alert list.

How can I check that my pack of Atazanavir (As Sulfate) And Ritonavir Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-0196, 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 Atazanavir (As Sulfate) And Ritonavir Tablets used for?

REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ] . • Use of REYATAZ with ritonavir in (Summarised from the official U.S. FDA label for atazanavir. Always follow your doctor or pharmacist.)

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