Gammanorm 165 mg/ml otopina za injekciju

Name	Gammanorm 165 mg/ml otopina za injekciju
Marketing Authorisation Number	HR-H-251167379
Active Substance	imunoglobulin normalni, ljudski
Composition	1 ml otopine sadrži 165 mg normalnog ljudskog imunoglobulina (od čega je najmanje 95% imunoglobulin G)
Pharmaceutical Form	otopina za injekciju
Manufacturer	Octapharma AB, Stockholm, Švedska
Marketing Authorisation Holder	Jana Pharm d.o.o., Lopašićeva 6, Zagreb
Marketing Authorisation Date	30.06.2017
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/16-02/153
Registration Number	381-12-01/30-17-08
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	J06BA01
Marketing status	stavljeno u promet
Shortage status	u tijeku
SmPC	download
PL	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s 6 ml otopine, u kutiji	HR-H-251167379-01	-	-
1 bočica s 10 ml otopine, u kutiji	HR-H-251167379-02	stavljeno u promet	u tijeku
1 bočica s 12 ml otopine, u kutiji	HR-H-251167379-03	stavljeno u promet	u tijeku
1 bočica s 20 ml otopine, u kutiji	HR-H-251167379-04	-	-
1 bočica s 24 ml otopine, u kutiji	HR-H-251167379-05	-	-
1 bočica s 48 ml otopine, u kutiji	HR-H-251167379-06	-	-
10 bočica s 6 ml otopine, u kutiji	HR-H-251167379-07	-	-
10 bočica s 10 ml otopine, u kutiji	HR-H-251167379-08	-	-
10 bočica s 12 ml otopine, u kutiji	HR-H-251167379-09	-	-
10 bočica s 20 ml otopine, u kutiji	HR-H-251167379-10	-	-
10 bočica s 24 ml otopine, u kutiji	HR-H-251167379-11	-	-
10 bočica s 48 ml otopine, u kutiji	HR-H-251167379-12	-	-
20 bočica s 6 ml otopine, u kutiji	HR-H-251167379-13	-	-
20 bočica s 10 ml otopine, u kutiji	HR-H-251167379-14	-	-
20 bočica s 12 ml otopine, u kutiji	HR-H-251167379-15	-	-
20 bočica s 20 ml otopine, u kutiji	HR-H-251167379-16	-	-
20 bočica s 24 ml otopine, u kutiji	HR-H-251167379-17	-	-
20 bočica s 48 ml otopine, u kutiji	HR-H-251167379-18	-	-

Medicinal Products