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Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_

NAFDAC Reg. No. A4-7487 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_
NAFDAC number
A4-7487
Active ingredient
Artemether; Lumefantrine
Strength
80 mg; 480 mg
Form
Tablet
Pack size
1 x 6's (in Alu-PVC blister)
Manufacturer
Not listed
Applicant (holder)
Brands Pharma & General Enterprises
Approved
30 Jul 2025
Status
Active View on NAFDAC ↗
Registration valid to
29 Jul 2030
WHO alerts
None found
Community reports
None
Times checked
0
Commonly used to treat malaria. General information only — confirm the correct course with a healthcare provider, especially for children or pregnant women.

RxVerify commentary

  • Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ is on the NAFDAC register with an active registration (A4-7487). 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 Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ is used for

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

What it is used for

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. …

Possible side effects

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. …

Do not use if

Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. …

Warnings

Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. ( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. …

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

NAFDAC recall & alert notices

Public Alert No. 023/2026 – Alert on Counterfeit Brands of Proguanil (Projeanil and Re-granil) Tablet B.P 100mg with Fake NAFDAC Registration Number (04-6433) found in Nigeria25 Mar 2026 · nafdac.gov.ngThe National Agency for Food and Drugs Administration and Control (NAFDAC) is informing healthcare professionals and the general public of the circulation of counterfeit brands of Proguanil tablets, specifically Projeanil and Re-granil, both at 100 mg B.P.The NAFDAC Registration Number (NRN) 04-6433 displayed on the pr…Public Alert No. 032/2023 – Alert on Parallel Importation of Novartis Brands30 Oct 2023 · nafdac.gov.ngThe National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of an observed parallel importation of some Novartis Prescription-Only-Medicines (POM) brands. The Ports Inspection Directorate of the Agency observed increased incidents of seizure of unregistered Novartis brands of some…Public Alert 0011/2022 – TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene8 Mar 2022 · nafdac.gov.ng, The National Agency for Food and Drug Administration and Control has been notified by US FDA that TCP HOT Acquisition LLC dba HRB Brands Stamford, USA is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table below to the consumer l…Public Alert No. 010/2022- Public Alert On Recall Of Five Brands Of ‘Male Enhancement’ Pills Sold On Amazon Due To Presence Of Undeclared Tadalafil/Sildenafil7 Mar 2022 · nafdac.gov.ng, The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the general public of the voluntary recall of four brands of male sexual enhancement pills by their manufacturing companies. These recalls were as a result of Amazon notifying the FDA of the laboratory analysis which found the prod…

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Check your pack of Brands Artemether 80 mg & Lumefantrine 480 mg 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 Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_

What is in Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_?

Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ contains Artemether; Lumefantrine (80 mg; 480 mg), as tablet, according to its NAFDAC registration record.

Is Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ registered with NAFDAC?

Yes. Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ is listed on the NAFDAC register under registration number A4-7487, and its registration is active as of 5 November 2026.

Has Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ in our automatically synced alert list.

How can I check that my pack of Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ is genuine?

Run a free authenticity scan with the NAFDAC number A4-7487, 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 Brands Artemether 80 mg & Lumefantrine 480 mg Tablets_ used for?

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets ar (Summarised from the official U.S. FDA label for artemether. Always follow your doctor or pharmacist.)

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