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ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg

NAFDAC Reg. No. C4-0681 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg
NAFDAC number
C4-0681
Active ingredient
Artemether; Lumefantrine
Strength
80 mg; 480 mg
Form
Tablet
Pack size
1 x 6's (in blister)
Manufacturer
Not listed
Applicant (holder)
Demytex Pharma Ltd
Approved
27 Mar 2024
Status
Active View on NAFDAC ↗
Registration valid to
26 Mar 2029
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.

What we found

  • ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg is on the NAFDAC register with an active registration (C4-0681). 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. This is not medical advice. Always follow your doctor or pharmacist.

What ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg 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. 042/2026-Alert on the Seizure of Suspected Substandard and Falsified BPPL Artemether/Lumefantrine 80mg/480mg19 Aug 2026 · nafdac.gov.ngThe National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs), and the general public of the seizure of a suspected Substandard and Falsified (SF) antimalarial medicine, Artemether/Lumefant…Public Alert No. 09/2026 – Public Reminder of NAFDAC’s Regulatory Directive on the Discontinued Registration of Multi-Dose Artemether /Lumefantrine Dry Powder for Oral Suspension20 Feb 2026 · nafdac.gov.ngThe National Agency for Food and Drugs Administration and Control (NAFDAC) is reminding the public of the Regulatory Directive issued last year on the discontinued registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for Oral Suspension due to the instability of the reconstituted formulations, …Public Alert No. 08/2025 –Alert on the Presence of Counterfeit Artemether/Lumefantrine Tablets Circulating Under Brand Name Aflotin 20/120 in Nigeria7 Apr 2025 · nafdac.gov.ngThe National Agency for Food and Drug Administration and Control is notifying the public of the presence of one batch of counterfeit Artemether/Lumefantrine tablets circulating under the brand name Aflotin 20/120 in Nigeria. The counterfeit product was discovered and reported to the Agency by the genuine manufacturer, …Public Alert No. 05/2025 – Alert on the Circulation of Falsified Cikatem (Artemether 180mg/Lumefantrine 1080mg) with Falsified NAFDAC Registration Number NRN A11-10002511 Mar 2025 · nafdac.gov.ngThe National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public about the circulation of a confirmed falsified Cikatem (Artemether 180mg/Lumefantrine 1080mg) suspension. This product was discovered in the Coordinated Wholesale Centre (CWC) in Kano following a consumer complaint receiv…

Compare the brands and batch numbers in these notices with your pack, or enter your batch number above.

Check your pack of ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg

What is in ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg?

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

Is ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg registered with NAFDAC?

Yes. ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg is listed on the NAFDAC register under registration number C4-0681, and its registration is active as of 28 October 2026.

Has ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg been flagged as fake or recalled?

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

How can I check that my pack of ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg is genuine?

Run a free authenticity scan with the NAFDAC number C4-0681, 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 ZMC Artemether & Lumefantrine Tablets 80 mg/480 mg 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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