Name |
Pantoprazol APharma 40 mg prašak za otopinu za injekciju |
Marketing Authorisation Number |
HR-H-772336364 |
Active Substance |
pantoprazolnatrij seskvihidrat |
Composition |
jedna bočica sadrži 40 mg pantoprazola (u obliku natrij seskvihidrata) |
Pharmaceutical Form |
prašak za otopinu za injekciju |
Manufacturer |
APL Swift Services (Malta) Ltd., Birzebbugia, Malta |
Marketing Authorisation Holder |
Apta Medica Internacional d.o.o., Likozarjeva ulica 6, Ljubljana, Slovenija |
Marketing Authorisation Date |
20.03.2025 |
MA Period of Validity |
20.03.2030 |
Classification Number |
UP/I-530-09/23-01/342 |
Registration Number |
381-12-01/171-25-09 |
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 |
A02BC02 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |