Name |
Haloperidol depo Krka 50 mg/ml otopina za injekciju s produljenim oslobađanjem |
Former Name |
Haldol depo 50 mg/ml otopina za injekciju |
Marketing Authorisation Number |
HR-H-978671231 |
Active Substance |
haloperidoldekanoat |
Composition |
1 ml otopine za injekciju (1 ampula) sadržava 50 mg haloperidola u obliku haloperidoldekanoata |
Pharmaceutical Form |
Otopina za injekciju s produljenim oslobađanjem |
Manufacturer |
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
Marketing Authorisation Holder |
Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
Marketing Authorisation Date |
28.04.2016 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/14-02/531 |
Registration Number |
381-12-01/30-16-07 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
N05AD01 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |