The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the withdrawal, suspension, or cancellation of 101 pharmaceutical products from circulation in Nigeria.
The agency announced the decision in a statement released on the its X handle on Tuesday saying the affected products “are therefore no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale and use within Nigeria.”
According to the agency, the action followed requests by market authorisation holders to withdraw some products, while others were suspended or cancelled by the agency.
It explained that the list which covers items across medicines and health products from antimalarials (various artemether/lumefantrine formulations) and cardiovascular drugs (valsartan products) to insulin/growth-hormone injectables (Norditropin), diabetes medicines (Januvia/Janumet), inhalers and eye drops can be accessed on the NAFDAC website.
Among the delisted drugs are Flagyl suspension and tablet which is widely used to treat diarrhoea; Artemether/Lumefantrine, an antimalarial; Penicillin G Sodium Sandoz powder, prescribed for bacterial infections; diabetes medicines (Januvia/Janumet), inhalers and eye drops.
“This is to inform the General Public that the following products are approved for withdrawal, suspension and cancellation by NAFDAC,” the statement reads.
“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“Please note that the certificate of registration of a product is said to be withdrawn when the use of the Certificate of Registration of that product is discontinued upon request of the Market Authorization Holder.”
List of Withdrawn, Suspended and Cancelled products as approved by NAFDAC
| 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Dispersible Tablets 60mg/30mg | Tablets | C4-1180 | Abacavir sulfate and Lamivudine | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 2 | Amaryl M Tablets | Tablets | A4-2619 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 3 | Amaryl M SR Tablets | Tablets | A4-7296 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria Ltd | Withdrawn Voluntarily by Market Authorization Holder |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 |
View complete list here
Ifunanya Ikueze is an Engineer, Safety Professional, Writer, Investor, Entrepreneur and Educator.
