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FULL LIST: Flagyl, Artemether-Lumefantrine among 101 drugs delisted by NAFDAC

Mojisola Adeyeye, director-general (DG) of the National Agency for Food and Drug Administration and Control (NAFDAC) Mojisola Adeyeye, director-general (DG) of the National Agency for Food and Drug Administration and Control (NAFDAC)
Mojisola Adeyeye, NAFDAC DG

The National Agency for Food and Drug Administration and Control (NAFDAC) says it has delisted 101 drugs from circulation in Nigeria.

In a statement on Tuesday, the agency said the affected products are no longer permitted for manufacturing, importation, exportation, distribution, advertisement, sale, or use in the country.

NAFDAC said the action followed requests by market authorisation holders to withdraw some products, while others were suspended or cancelled by the agency.

The agency noted that a suspension applies when the conditions under which a registration licence was issued are no longer met, while a cancellation occurs when NAFDAC revokes a product’s licence.

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The delisted products cut across a wide range of medicines and health items — from antimalarials (various artemether/lumefantrine formulations) and cough treatments to vaccines (such as Cryomarex Rispens HVT), insulin and growth-hormone injectables (like Norditropin), diabetes medicines (Januvia/Janumet), inhalers, and eye drops.

Checks by TheCable showed that some popular medicines are on the list, including Flagyl suspension and tablet — widely used to treat diarrhoea; Penicillin G Sodium Sandoz powder, prescribed for bacterial infections; Artemether/Lumefantrine, an antimalarial; and Elisca eye drops, used in treating eye infections.

“This is to inform the General Public that the following products are approved for withdrawal, suspension and cancellation by NAFDAC,” the statement reads.

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“They are therefore no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale and use within Nigeria.

“Please note that the certificate of registration of a product is said to be withdrawn when the use of the Certificate of Registration of that product is discontinued upon request of the Market Authorization Holder.”

See full list below

S/N Product name Dosage form NAFDAC Number Active Ingredient Market Authorization Holder Application Purpose
1 Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg Tablets C4-1180 Abacavir sulfate and Lamivudine Healthline Limited Withdrawn Voluntarily by Market Authorization Holder
2 Amaryl M Tablets Tablets A4-2619 Glimepiride + Metformin Hydrochloride Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
3 Amaryl M SR Tablets Tablets A4-7296 Glimepiride + Metformin Hydrochloride Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
4 Aprovasc 150mg/5mg tablets Tablets B4-2687 Amlodipine Besylate + ? (Aprovasc) Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
5 Artemether/Lumefantrine 40mg/240mg Tablets Tablets B4-5745 Artemether/Lumefantrine 40mg/240mg Healthline Limited Withdrawn Voluntarily by Market Authorization Holder
6 ASAQ (Artesunate amodiaquine Winthrop) 100mg/270mg Tablets Tablets A4-3357 Artesunate Amodiaquine Winthrop 100mg/270mg Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
7 ASAQ (Artesunate amodiaquine Winthrop) 25mg/67.5mg Tablets Tablets A4-3406 Artesunate Amodiaquine Winthrop 25mg/67.5mg Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
8 ASAQ (Artesunate amodiaquine Winthrop) 50mg/135mg Tablets Tablets A4-3405 Artesunate Amodiaquine Winthrop 50mg/135mg Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder
9 Betopic Eye drop Eye Drop 04 2404 Betaxolol Hydrochloride Novartis Nigeria Limited Withdrawn Voluntarily by Market Authorization Holder
10 Coaprovel 300mg/25mg Tablets Tablets B4-2317 Hydrochlorothiazide + Irbesartan Sanofi Aventis Nigeria Ltd Withdrawn Voluntarily by Market Authorization Holder

Others can be found here.

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