| Name |
Oramorph 20 mg/ml oralne kapi, otopina |
| Marketing Authorisation Number |
HR-H-382315908 |
| Active Substance |
morfinsulfat |
| Composition |
1 ml otopine sadrži 20 mg morfinsulfata |
| Pharmaceutical Form |
oralne kapi, otopina |
| Manufacturer |
L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A., Scandicci, Firenza, Italija |
| Marketing Authorisation Holder |
L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, Scandicci, Firenza, Italija |
| Marketing Authorisation Date |
30.09.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/20-02/75 |
| Registration Number |
381-12-01/30-20-04 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
poseban recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N02AA01 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
