Name |
Aspigola 8,75 mg po dozi, sprej za usnu sluznicu, otopina |
Former Name |
Flurbiprofen Bayer 8,75 mg po dozi, sprej za usnu sluznicu, otopina |
Marketing Authorisation Number |
HR-H-109653856 |
Active Substance |
flurbiprofen |
Composition |
jedna doza (3 potiska) sadržava 8,75 mg flurbiprofena jedan potisak sadržava 2,91 mg flurbiprofena jedan ml otopine u spreju za usnu sluznicu sadržava 17,16 mg flurbiprofena |
Pharmaceutical Form |
Sprej za usnu sluznicu, otopina |
Manufacturer |
Laboratorium Sanitatis S.L., Miñano, Alava, Španjolska |
Marketing Authorisation Holder |
Bayer d.o.o., Radnička cesta 80, Zagreb, Hrvatska |
Marketing Authorisation Date |
24.11.2022 |
MA Period of Validity |
24.11.2027 |
Classification Number |
UP/I-530-09/21-01/129 |
Registration Number |
381-12-01/70-22-09 |
Prescription |
Medicinal product not subject to medical prescription |
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
allowed |
ATC Code |
R02AX01 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Summary of risk management plan |
download |