| Name |
Colopridix 1 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-687760915 |
| Active Substance |
prukalopridsukcinat |
| Composition |
jedna filmom obložena tableta sadrži 1 mg prukaloprida (u obliku sukcinata) |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Combino Pharm (Malta) Ltd., Birzebbuga, Malta |
| Marketing Authorisation Holder |
Pontus Pharma d.o.o., Ulica Kralja Zvonimira 62, Zagreb, Hrvatska |
| Marketing Authorisation Date |
10.07.2024 |
| MA Period of Validity |
10.07.2029 |
| Classification Number |
UP/I-530-09/23-01/126 |
| Registration Number |
381-12-01/70-24-08 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
neponovljivi recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A06AX05 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
