Monitor this situation.

Unsubscribe anytime.

[SITUATION] · [QUIET] · [HEALTH]

2 clusters · 7 sources · 5 days · First seen 23 days ago · Last updated 18 days ago

Biofarm medicine sales suspension in Romania

Overview

The manufacturer Biofarm suspended the sale of digestive and biliary medicines Colebil and Panzcebil across all distribution channels in Romania following a request from the National Agency for Medicines and Medical Devices (ANMDMR).

Initially, Biofarm characterized the suspension as a purely administrative measure intended to clarify product documentation, maintaining that the drugs met all safety and quality standards. However, subsequent reports indicated that the halt followed a reevaluation of the medications' benefit-risk ratio. These reports cited recent studies questioning the effectiveness of the active components and noted adverse reactions related to the gastrointestinal tract and liver in long-term users.

Entities

Panzcebil · National Agency for Medicines and Medical Devices (ANMDMR) · Biofarm · National Agency for Medicines and Medical Devices of Romania · Biofarm SA

Timeline

18 days ago

[HEALTH] 2 sources
Biofarm medicines Colebil and Panzcebil suspended in Romania
Romanian health authorities have suspended the sale of Colebil and Panzcebil medications for documentation review and benefit-risk reassessment.
23 days ago

[HEALTH] 5 sources
Biofarm suspends sales of Colebil and Panzcebil in Romania
Biofarm temporarily halted sales of Colebil and Panzcebil in Romania after ANMDMR requested documentation clarification; safety is unchanged and no resumption date is set.

Sources

botosaninews.ro · exquis.ro · news.yam.md · realitatea.net · sibiu100.ro · soba.sanze.jp · ziarulunirea.ro