Biofarm medicines Colebil and Panzcebil suspended in Romania

The National Agency for Medicines and Medical Devices of Romania (ANMDMR) has ordered a temporary halt on the sale of two medications, Colebil and Panzcebil, across the entire distribution chain, including pharmacies.

Biofarm SA, the manufacturer, stated that the measure was requested by the regulatory agency to clarify documentation related to the products. The company emphasized that the products continue to meet quality and safety standards and that the decision is not linked to product safety concerns.

Separate reports indicate that the withdrawal follows a reevaluation of the benefit-risk ratio for these digestive and biliary treatments. Recent studies have questioned the effectiveness of the active components, and some adverse reactions regarding the liver and gastrointestinal tract have been noted in long-term users. Because these medications were widely available without a prescription, the removal may prompt consumers to seek alternative treatments.