Folinatna kiselina Kalceks 10 mg/ml otopina za injekciju/infuziju

Name	Folinatna kiselina Kalceks 10 mg/ml otopina za injekciju/infuziju
Marketing Authorisation Number	HR-H-418598764
Active Substance	kalcijev folinat hidrat
Composition	1 ml otopine sadrži 10 mg folinatne kiseline u obliku kalcijevog folinata hidrata
Pharmaceutical Form	Otopina za injekciju / infuziju
Manufacturer	AS Kalceks, Riga, Latvija
Marketing Authorisation Holder	AS Kalceks, Krustpils iela 71E, Riga, Latvija
Marketing Authorisation Date	27.12.2023
MA Period of Validity	27.12.2028
Classification Number	UP/I-530-09/23-01/15
Registration Number	381-12-01/171-23-10
Prescription	na recept
Type of prescription	ograničeni recept
Distribution	u ljekarni
Advertising to general public	zabranjeno
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s 5 ml otopine, u kutiji	HR-H-418598764-01	-	-
5 bočica s 5 ml otopine, u kutiji	HR-H-418598764-02	-	-
10 bočica s 5 ml otopine, u kutiji	HR-H-418598764-03	-	-
1 bočica s 10 ml otopine, u kutiji	HR-H-418598764-04	-	-
10 bočica s 10 ml otopine, u kutiji	HR-H-418598764-05	Nije stavljeno u promet	-
1 bočica s 20 ml otopine, u kutiji	HR-H-418598764-06	Nije stavljeno u promet	-
10 bočica s 20 ml otopine, u kutiji	HR-H-418598764-07	Nije stavljeno u promet	-
1 bočica s 30 ml otopine, u kutiji	HR-H-418598764-08	-	-
10 bočica s 30 ml otopine, u kutiji	HR-H-418598764-09	-	-
1 bočica s 50 ml otopine, u kutiji	HR-H-418598764-10	-	-
10 bočica s 50 ml otopine, u kutiji	HR-H-418598764-11	-	-
1 bočica sa 100 ml otopine, u kutiji	HR-H-418598764-12	-	-
10 bočica sa 100 ml otopine, u kutiji	HR-H-418598764-13	-	-

Medicinal Products