Biofarm a anunțat că medicamentul Colebil nu mai poate fi comercializat temporar în România, după ce Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR) a decis blocarea vânzării pe întregul lanț de distribuție. Compania susține că decizia nu este legată de calitatea sau siguranța produsului.
Colebil dispare temporar din farmacii Foto: Shuterstock
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Anunțul a fost făcut marți, 4 august, printr-un raport transmis Bursei de Valori București (BVB), în care Biofarm precizează că măsura vizează atât Colebil drajeuri, cât și Panzcebil drajeuri gastrorezistente.
„Pentru produsele Colebil, drajeuri, Panzcebil, drajeuri gastrorezistente, a fost emisă o decizie de blocare a vânzării pe întregul lanț de distribuție, până la nivelul farmaciilor, ca urmare a solicitării Agenției Naționale a Medicamentului și a Dispozitivelor Medicale din România, în scopul clarificării documentației pentru produsele menționate”, se arată în raportul companiei, potrivit Agerpres.
Reprezentanții Biofarm subliniază că decizia are un caracter administrativ și nu este determinată de probleme privind calitatea sau siguranța celor două medicamente.
„Aceste produse continuă să îndeplinească standardele de calitate și de siguranță pentru pacient”, au transmis reprezentanții companiei.
Deocamdată, Biofarm nu a precizat cât timp va rămâne în vigoare măsura și nici când ar putea fi reluată comercializarea celor două produse.
Vânzarea va putea fi reluată după finalizarea procesului de clarificare a documentației solicitate de ANMDMR.
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