The National Agency for Food and Drug Administration and Control (NAFDAC) has said 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NAFDAC explained that some of the products were withdrawn voluntarily at the request of market authorization holders, while others were suspended or outrightly cancelled by the agency.
A suspension, they said, applies when the conditions under which a registration licence was issued are no longer met, while a cancellation occurs when the agency revokes a product’s licence.
The delisted products cut across a wide range of medicines and health items — from antimalarials and cough treatments to vaccines, insulin and growth-hormone injectables, diabetes medicines, inhalers, and eye drops.
Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg – withdrawn voluntarily by Healthline Limited.
Amaryl M Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Amaryl M SR Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Aprovasc 150mg/5mg Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Artemether/Lumefantrine 40mg/240mg Tablets – withdrawn voluntarily by Healthline Limited.
ASAQ (Artesunate amodiaquine Winthrop) Tablets (various strengths) – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Betopic Eye Drops – withdrawn voluntarily by Novartis Nigeria Limited
Coaprovel 300mg/25mg Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd
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NAFDAC explained that some of the products were withdrawn voluntarily at the request of market authorization holders, while others were suspended or outrightly cancelled by the agency.
A suspension, they said, applies when the conditions under which a registration licence was issued are no longer met, while a cancellation occurs when the agency revokes a product’s licence.
The delisted products cut across a wide range of medicines and health items — from antimalarials and cough treatments to vaccines, insulin and growth-hormone injectables, diabetes medicines, inhalers, and eye drops.
“This is to inform the general public that the following products are approved for withdrawal, suspension and cancellation by NAFDAC. They are therefore no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale and use within Nigeria.Some of the delisted drugs include:
“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,” the statement reads.
Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg – withdrawn voluntarily by Healthline Limited.
Amaryl M Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Amaryl M SR Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Aprovasc 150mg/5mg Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Artemether/Lumefantrine 40mg/240mg Tablets – withdrawn voluntarily by Healthline Limited.
ASAQ (Artesunate amodiaquine Winthrop) Tablets (various strengths) – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd.
Betopic Eye Drops – withdrawn voluntarily by Novartis Nigeria Limited
Coaprovel 300mg/25mg Tablets – withdrawn voluntarily by Sanofi Aventis Nigeria Ltd
Others affected include:
Flagyl suspension and tablets, used to treat diarrhoea
Penicillin G Sodium Sandoz, prescribed for bacterial infections
Elisca eye drops, used in treating infections
Flagyl suspension and tablets, used to treat diarrhoea
Penicillin G Sodium Sandoz, prescribed for bacterial infections
Elisca eye drops, used in treating infections
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