Dolten 100 mg filmom obložene tablete

Name	Dolten 100 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-011900346
Active Substance	tapentadolklorid
Composition	jedna filmom obložena tableta sadrži 116,48 mg tapentadolklorida, što odgovara 100 mg tapentadola
Pharmaceutical Form	Filmom obložena tableta
Manufacturer	Medochemie Ltd., Agios Athanassios, Limassol, Cipar
Marketing Authorisation Holder	Medochemie Ltd., Constatinoupoleos Str. 1-10, Limassol, Cipar
Marketing Authorisation Date	05.04.2023
MA Period of Validity	05.04.2028
Classification Number	UP/I-530-09/21-01/313
Registration Number	381-12-01/70-23-05
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	N02AX06
Marketing status	nije stavljeno u promet
SmPC	download
PL	download
Public Assessment Report	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
5 tableta u blisteru, u kutiji	HR-H-011900346-01	-	-
10 tableta u blisteru, u kutiji	HR-H-011900346-02	-	-
14 tableta u blisteru, u kutiji	HR-H-011900346-03	-	-
20 tableta u blisteru, u kutiji	HR-H-011900346-04	-	-
24 tableta u blisteru, u kutiji	HR-H-011900346-05	-	-
28 tableta u blisteru, u kutiji	HR-H-011900346-06	nije stavljeno u promet	-
30 tableta u blisteru, u kutiji	HR-H-011900346-07	-	-
40 tableta u blisteru, u kutiji	HR-H-011900346-08	nije stavljeno u promet	-
50 tableta u blisteru, u kutiji	HR-H-011900346-09	-	-
54 tableta u blisteru, u kutiji	HR-H-011900346-10	-	-
56 tableta u blisteru, u kutiji	HR-H-011900346-11	-	-
60 tableta u blisteru, u kutiji	HR-H-011900346-12	-	-
90 tableta u blisteru, u kutiji	HR-H-011900346-13	-	-
100 tableta u blisteru, u kutiji	HR-H-011900346-14	nije stavljeno u promet	-

Medicinal Products