| Name |
Sab simplex 64 mg/ml oralna suspenzija |
| Marketing Authorisation Number |
HR-H-076165718 |
| Active Substance |
simetikon |
| Composition |
1 ml (približno 25 kapi) oralne suspenzije sadrži 69,19 mg simetikona što odgovara 64 mg dimetikona (dimetikon 350 i silicijev dioksid u omjeru 92,5: 7,5) |
| Pharmaceutical Form |
oralna suspenzija |
| Manufacturer |
Delpharm Orléans, Orleans Cedex 2, Francuska |
| Marketing Authorisation Holder |
Pfizer Croatia d.o.o., Slavonska avenija 6, Zagreb, Hrvatska |
| Marketing Authorisation Date |
18.12.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/18-02/184 |
| Registration Number |
381-12-01/30-20-04 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
allowed |
| ATC Code |
A03AX13 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |