Udihep 250 mg tvrde kapsule

Name	Udihep 250 mg tvrde kapsule
Marketing Authorisation Number	HR-H-122620972
Active Substance	ursodeoksikolatna kiselina
Composition	jedna tvrda kapsula sadrži 250 mg ursodeoksikolatne kiseline
Pharmaceutical Form	Kapsula, tvrda
Manufacturer	Fairmed Healthcare GmbH, Lübeck, Njemačka
Marketing Authorisation Holder	Novatin Limited, 5a Bokka Tac-Carcara, Limiti Ta'L-Mgarr, Malta
Marketing Authorisation Date	18.09.2024
MA Period of Validity	18.09.2029
Classification Number	UP/I-530-09/24-01/169
Registration Number	381-12-01/171-24-07
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product on medical prescription for renewable delivery
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	A05AA02
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
20 kapsula u blisteru, u kutiji	HR-H-122620972-01	Never marketed	-
28 kapsula u blisteru, u kutiji	HR-H-122620972-02	Never marketed	-
30 kapsula u blisteru, u kutiji	HR-H-122620972-03	Never marketed	-
50 kapsula u blisteru, u kutiji	HR-H-122620972-04	Never marketed	-
56 kapsula u blisteru, u kutiji	HR-H-122620972-05	Never marketed	-
60 kapsula u blisteru, u kutiji	HR-H-122620972-06	Never marketed	-
100 kapsula u blisteru, u kutiji	HR-H-122620972-07	Marketed	No shortage
120 kapsula u blisteru, u kutiji	HR-H-122620972-08	Never marketed	-

Medicinal Products