Colebil and Panzcebil Temporarily Withdrawn from Pharmacies. What the Medicines Agency Says

The National Agency for Medicines and Medical Devices of Romania (ANMDMR) has decided to temporarily block certain batches of two medicines widely used by Romanian patients: Colebil coated tablets (MA No. 13377/2020/01) and Panzcebil gastro-resistant coated tablets (MA No. 5223/2012/01-02). Both products are manufactured by Biofarm SA and sold in pharmacies across the country.

According to ANMDMR, the measure is preventive and temporary, and has been taken pending clarification of certain matters relating to the manufacturer of the active substance used as a raw material — bovine bile — which is used in the production of both medicines.

The Agency has clarified that the investigations are not related to the manufacturing process carried out by Biofarm SA and that, at this stage, there are no indications of any quality or safety issues with the finished products. The situation in fact concerns the clarification of the compliance status and authorisations held by the manufacturer of the active substance contained in both of these biological medicines for human use.

"The situation under review concerns the clarification of the compliance status and authorisations held by the manufacturer of the active substance contained in the two biological medicines for human use," the ANMDMR press statement reads.

The Agency is working with the competent authority in the country where the raw material manufacturer operates, in order to verify compliance with good manufacturing practice standards. According to ANMDMR, Biofarm SA has supported the authorities' efforts to resolve the situation as swiftly as possible.

Until the investigations are concluded, batches held at the manufacturer's warehouse and within the distribution chain, including at pharmacy level, may not be sold.

"The assessment of data resulting from the investigations will be carried out as a matter of priority, with a view to ensuring that patients in Romania have access to medicines of unquestionable quality and safety," the National Agency for Medicines further stated.