Name |
Respimucil 600 mg granule za oralnu otopinu u vrećici |
Former Name |
Acetilcistein Pharmexon 600 mg granule za oralnu otopinu u vrećici |
Marketing Authorisation Number |
HR-H-720547433 |
Active Substance |
acetilcistein |
Composition |
jedna vrećica sadrži 600 mg acetilcisteina |
Pharmaceutical Form |
Granule za oralnu otopinu u vrećici |
Manufacturer |
Zambon S.p.A., Vicenza, Italija |
Marketing Authorisation Holder |
Zambon S.p.A., Via Lillo del Duca, 10, Bresso (Milano), Italija |
Marketing Authorisation Date |
25.05.2023 |
MA Period of Validity |
03.12.2026 |
Classification Number |
UP/I-530-09/19-01/266 |
Registration Number |
381-12-01/154-23-11 |
Prescription |
bez recepta |
Distribution |
u ljekarni |
Advertising to general public |
dopušteno |
ATC Code |
R05CB01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |