Deksametazon Kalceks 4 mg/ml otopina za injekciju/infuziju

Name	Deksametazon Kalceks 4 mg/ml otopina za injekciju/infuziju
Marketing Authorisation Number	HR-H-195627237
Active Substance	natrijev deksametazonfosfat
Composition	1 ml otopine sadrži 4 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata) 2 ml otopine sadrži 8 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata)
Pharmaceutical Form	Otopina za injekciju / infuziju
Manufacturer	AS Kalceks, Riga, Latvija
Marketing Authorisation Holder	AS Kalceks, Krustpils iela 53, Riga, Latvija
Marketing Authorisation Date	01.12.2021
MA Period of Validity	01.12.2026
Classification Number	UP/I-530-09/20-01/252
Registration Number	381-12-01/154-21-05
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	H02AB02
Marketing status	nije stavljeno u promet
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
3 ampule s 1 ml otopine, u kutiji	HR-H-195627237-01	nije stavljeno u promet	-
10 ampula s 1 ml otopine, u kutiji	HR-H-195627237-02	nije stavljeno u promet	-
25 ampula s 1 ml otopine, u kutiji	HR-H-195627237-03	nije stavljeno u promet	-
50 ampula s 1 ml otopine, u kutiji	HR-H-195627237-04	nije stavljeno u promet	-
100 ampula s 1 ml otopine, u kutiji	HR-H-195627237-05	nije stavljeno u promet	-
5 ampula s 2 ml otopine, u kutiji	HR-H-195627237-06	nije stavljeno u promet	-
10 ampula s 2 ml otopine, u kutiji	HR-H-195627237-07	nije stavljeno u promet	-
25 ampula s 2 ml otopine, u kutiji	HR-H-195627237-08	nije stavljeno u promet	-
50 ampula s 2 ml otopine, u kutiji	HR-H-195627237-09	nije stavljeno u promet	-
100 ampula s 2 ml otopine, u kutiji	HR-H-195627237-10	nije stavljeno u promet	-

Medicinal Products