Esgamda 25 mg/ml otopina za injekciju/infuziju

Name	Esgamda 25 mg/ml otopina za injekciju/infuziju
Marketing Authorisation Number	HR-H-664987175
Active Substance	esketaminklorid
Composition	1 ml otopine za injekciju/infuziju sadrži 25 mg esketamina, u obliku esketaminklorida
Pharmaceutical Form	Otopina za injekciju / infuziju
Manufacturer	G.L. Pharma GmbH, Lannach, Austrija
Marketing Authorisation Holder	Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska
Marketing Authorisation Date	17.05.2022
MA Period of Validity	17.05.2027
Classification Number	UP/I-530-09/21-01/140
Registration Number	381-12-01/38-22-05
Prescription	na recept
Type of prescription	poseban i ograničeni recept
Distribution	u ljekarni
Advertising to general public	zabranjeno
ATC Code	N01AX14
Medicinal product marketed in the Croatia	Da
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 ampula s 2 ml otopine, u kutiji	HR-H-664987175-01	-	-
5 ampula s 2 ml otopine, u kutiji	HR-H-664987175-02	-	-
10 ampula s 2 ml otopine, u kutiji	HR-H-664987175-03	-	-
15 ampula s 2 ml otopine, u kutiji	HR-H-664987175-04	-	-
20 ampula s 2 ml otopine, u kutiji	HR-H-664987175-05	-	-
25 ampula s 2 ml otopine, u kutiji	HR-H-664987175-06	-	-
30 ampula s 2 ml otopine, u kutiji	HR-H-664987175-07	-	-
35 ampula s 2 ml otopine, u kutiji	HR-H-664987175-08	-	-
40 ampula s 2 ml otopine, u kutiji	HR-H-664987175-09	-	-
45 ampula s 2 ml otopine, u kutiji	HR-H-664987175-10	-	-
50 ampula s 2 ml otopine, u kutiji	HR-H-664987175-11	-	-
55 ampula s 2 ml otopine, u kutiji	HR-H-664987175-12	-	-
60 ampula s 2 ml otopine, u kutiji	HR-H-664987175-13	-	-
65 ampula s 2 ml otopine, u kutiji	HR-H-664987175-14	-	-
70 ampula s 2 ml otopine, u kutiji	HR-H-664987175-15	-	-
75 ampula s 2 ml otopine, u kutiji	HR-H-664987175-16	-	-
80 ampula s 2 ml otopine, u kutiji	HR-H-664987175-17	-	-
85 ampula s 2 ml otopine, u kutiji	HR-H-664987175-18	-	-
90 ampula s 2 ml otopine, u kutiji	HR-H-664987175-19	-	-
95 ampula s 2 ml otopine, u kutiji	HR-H-664987175-20	-	-
100 ampula s 2 ml otopine, u kutiji	HR-H-664987175-21	-	-
1 ampula s 5 ml otopine, u kutiji	HR-H-664987175-22	-	-
5 ampula s 5 ml otopine, u kutiji	HR-H-664987175-23	-	-
10 ampula s 5 ml otopine, u kutiji	HR-H-664987175-24	-	-
15 ampula s 5 ml otopine, u kutiji	HR-H-664987175-25	-	-
20 ampula s 5 ml otopine, u kutiji	HR-H-664987175-26	-	-
25 ampula s 5 ml otopine, u kutiji	HR-H-664987175-27	-	-
30 ampula s 5 ml otopine, u kutiji	HR-H-664987175-28	-	-
35 ampula s 5 ml otopine, u kutiji	HR-H-664987175-29	-	-
40 ampula s 5 ml otopine, u kutiji	HR-H-664987175-30	-	-
45 ampula s 5 ml otopine, u kutiji	HR-H-664987175-31	-	-
50 ampula s 5 ml otopine, u kutiji	HR-H-664987175-32	-	-
55 ampula s 5 ml otopine, u kutiji	HR-H-664987175-33	-	-
60 ampula s 5 ml otopine, u kutiji	HR-H-664987175-34	-	-
65 ampula s 5 ml otopine, u kutiji	HR-H-664987175-35	-	-
70 ampula s 5 ml otopine, u kutiji	HR-H-664987175-36	-	-
75 ampula s 5 ml otopine, u kutiji	HR-H-664987175-37	-	-
80 ampula s 5 ml otopine, u kutiji	HR-H-664987175-38	-	-
85 ampula s 5 ml otopine, u kutiji	HR-H-664987175-39	-	-
90 ampula s 5 ml otopine, u kutiji	HR-H-664987175-40	-	-
95 ampula s 5 ml otopine, u kutiji	HR-H-664987175-41	-	-
100 ampula s 5 ml otopine, u kutiji	HR-H-664987175-42	-	-
1 ampula s 10 ml otopine, u kutiji	HR-H-664987175-43	-	-
5 ampula s 10 ml otopine, u kutiji	HR-H-664987175-44	-	-
10 ampula s 10 ml otopine, u kutiji	HR-H-664987175-45	-	-
15 ampula s 10 ml otopine, u kutiji	HR-H-664987175-46	-	-
20 ampula s 10 ml otopine, u kutiji	HR-H-664987175-47	-	-
25 ampula s 10 ml otopine, u kutiji	HR-H-664987175-48	-	-
30 ampula s 10 ml otopine, u kutiji	HR-H-664987175-49	-	-
35 ampula s 10 ml otopine, u kutiji	HR-H-664987175-50	-	-
40 ampula s 10 ml otopine, u kutiji	HR-H-664987175-51	-	-
45 ampula s 10 ml otopine, u kutiji	HR-H-664987175-52	-	-
50 ampula s 10 ml otopine, u kutiji	HR-H-664987175-53	-	-
55 ampula s 10 ml otopine, u kutiji	HR-H-664987175-54	-	-
60 ampula s 10 ml otopine, u kutiji	HR-H-664987175-55	-	-
65 ampula s 10 ml otopine, u kutiji	HR-H-664987175-56	-	-
70 ampula s 10 ml otopine, u kutiji	HR-H-664987175-57	-	-
75 ampula s 10 ml otopine, u kutiji	HR-H-664987175-58	-	-
80 ampula s 10 ml otopine, u kutiji	HR-H-664987175-59	-	-
85 ampula s 10 ml otopine, u kutiji	HR-H-664987175-60	-	-
90 ampula s 10 ml otopine, u kutiji	HR-H-664987175-61	-	-
95 ampula s 10 ml otopine, u kutiji	HR-H-664987175-62	-	-
100 ampula s 10 ml otopine, u kutiji	HR-H-664987175-63	-	-