“SFDA” Withdraws and Suspends the Registration of Pharmaceutical Product “Proton”2021-03-15
The Saudi Food & Drug Authority (SFDA) has announced the withdrawal and suspension of registration of the pharmaceutical product “PROTON 40mg E.C TABLET, batch number (134-212-01 &134-212-01) and “PROTON 20mg E.C TABLET, batch number (134-212-01 &135-212-01),
The Proton brand was manufactured by the Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO)
It has withdrawn the medicine from the Kingdom, and suspended its registration due to the medicine’s non-bio equivalence to the reference product.
The Authority addressed health authorities to withdraw all lots of the affected products as soon as it is available, calling on the medicine users to contact their doctors to receive the alternative medication.
The Authority’s circular based on the decision of the registration of pharmaceutical companies and their products Committee (No 18/1061/sfda/42), to suspend the registration and withdrawal the product.