Florence Sadiku
THE National Agency for Food and Drug Administration and Control (NAFDAC) says it has discontinued the registration of multi-dose antimalarial Artemether/Lumefantrine dry powder for oral suspension.
This decision was made due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time, the agency has said.
This suspension applies to all locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder for oral use. “Please, note that NAFDAC will no longer accept new applications, renewal applications, or variation applications for any local or imported multi-dose Artemether/Lumefantrine dry powder for oral suspension”, the agency stated in a release.
Product details:
Product Brand Name: All brands of multi-dose Artemether/Lumefantrine dry powder oral Suspension.
Product Manufacturer: All manufacturers and importers of multi-dose antimalarial Artemether/Lumefantrine dry powder oral suspension.
“Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to immediately stop the importation, distribution, sale, and use of all multi-dose Artemether/Lumefantrine dry powder oral suspension products.
“Healthcare professionals and consumers are advised to report any suspicion of sale of these products, substandard and falsified medicines, or medical devices to the nearest NAFDAC office, call 0800-162-3322 or send an email to sf.alert@nafdac.gov.ng”.
Eighteen-Eleven Media