June 7, 2019 / 6:06 AM / 10 days ago

BRIEF-Celon Pharma Updates On Market Status Of Valzek Drug

June 7 (Reuters) - Celon Pharma SA:

* SAID ON THURSDAY THAT CHIEF PHARMACEUTICAL INSPECTORATE HAS DECIDED TO RESTORE TRADING OF MORE THAN 200 SERIES OF VALZEK DRUG, IN 80 MG AND 160 MG DOSES, PREVIOUSLY SUSPENDED IN THE WHOLE COUNTRY AS OF AUGUST 2018

* AT THE SAME TIME, CHIEF PHARMACEUTICAL INSPECTORATE HAS WITHDREW FROM TRADING SELECTED SERIES OF VALZEK, PREVIOUSLY SUSPENDED AS OF AUGUST 2018

* SAID THAT THE DECISION TO WITHDREW THE DRUG WAS MADE ON THE COMPANY’S MOTION

* THE OBTAINED FINAL RESULTS OF THE QUALITATIVE TESTS OF THE ACTIVE SUBSTANCE VALSARTAN CONTAINED IN THESE BATCHES OF THE DRUG SHOWED A SLIGHT EXCEEDING OF THE LEVELS OF NDMA POLLUTION (NITROSODIMETHYLAMINE)

* THE IDENTIFIED LEVEL OF POLLUTION DOES NOT THREATEN THE LIFE AND HEALTH OF PATIENTS

* ESTIMATES THAT THE COSTS INCURRED BY THE COMPANY AS A RESULT RETURNING OF WITHDRAWN PACKAGES OF MEDICINES BY PATIENTS TO PHARMACIES WILL NOT EXCEED THE ALREADY PROVISIONED AMOUNT OF 650,000 ZLOTYS

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

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