The National Agency for Food and Drugs Administration and Control (NAFDAC) wishes to inform the public about the sighting of unregistered Simbrinza Eye Drops with batch number VAF36C in Port Harcourt, Nigeria.
The Marketing Authorization Holder (MAH) of the registered brand (Norvartis) reportedly sighted the unregistered brand of Simbrinza Eye Drops in Port Harcourt, Rivers State. The noticeable difference is the non-English inscription on the pack.
Simbrinza Eye Drops contain two medications (brinzolamide and brimonidine) used to treat high eye pressure due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). Lowering high pressure in the eye reduces the risk of vision loss, nerve damage, or blindness.
Risk
The illegal distribution and sale of unregistered eye drops, and other regulated products pose a risk to the safety, quality, and efficacy of the product is not guaranteed.
Product details
The details of the falsified eye drops are as follows.
Product Name | Simbrinza Eye Drop 10mg/ml + 2mg/ml (Brinzolamide+Brimonidine) |
Stated Manufacturer | Novartis |
Batch No. | VAF36C |
Labelling | The labeling on the pack of the product is not in English Language. |
Product photo | Not Provided |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the unregistered products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and consumers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sales, and use of illegally distributed products. All medical products/ medical devices must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
