Regulator Approves Eye Treatment: The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the use of polihexanide, marketed as Akantior, in the treatment of acanthamoeba keratitis. This condition is a serious infection of the cornea, the transparent outer layer at the front of the eye, which can cause significant pain and potentially lead to vision loss if not properly managed.
The approval of polihexanide was facilitated through the International Recognition Procedure (IRP), a regulatory pathway that enables the MHRA to leverage the expertise and decisions of trusted regulatory partners from other countries. This approach allows for a more efficient review process while maintaining rigorous standards for safety and efficacy.
Polihexanide is administered directly into the eye in the form of an eye drop solution. This method of administration is designed to deliver the medication precisely where it is needed, potentially enhancing its effectiveness in treating the infection.
The MHRA conducts a thorough and targeted assessment of applications submitted through the IRP. Although the agency relies on the expertise of its international partners, it retains full authority to reject any application if the evidence provided does not meet its standards for safety and efficacy.
As with any medicinal product, polihexanide’s safety and effectiveness will be closely monitored by the MHRA. Patients and healthcare professionals are encouraged to report any suspected side effects through the MHRA’s Yellow Card scheme. This can be done via the MHRA website or by downloading the Yellow Card app from the Google Play or Apple App stores.
Detailed information on the side effects of polihexanide can be found in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC), both of which will be available on the MHRA website following the approval. These documents provide comprehensive details about the medication, including its indications, dosage, potential side effects, and contraindications.
Still on Regulator Approves Eye Treatment
By approving polihexanide for the treatment of acanthamoeba keratitis, the MHRA is making available a new therapeutic option for patients suffering from this challenging condition. The agency’s ongoing oversight will help ensure that the benefits of this treatment continue to outweigh any risks for patients in the UK.
Police extradite Nigerian fugitive from UAE in connection with $307,500 fraud
Would you like to Earn Money Online with just your mobile device?
If yes then click on the link below:
