Esgamda 5 mg/ml otopina za injekciju/infuziju

Name	Esgamda 5 mg/ml otopina za injekciju/infuziju
Marketing Authorisation Number	HR-H-120966702
Active Substance	esketaminklorid
Composition	1 ml otopine za injekciju/infuziju sadrži 5 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-530-09/21-01/139
Registration Number	381-12-01/38-22-09
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to special and restricted medical prescription
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	N01AX14
Marketing status	Never marketed
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-120966702-01	Never marketed	-
5 ampula s 2 ml otopine, u kutiji	HR-H-120966702-02	Never marketed	-
10 ampula s 2 ml otopine, u kutiji	HR-H-120966702-03	Never marketed	-
15 ampula s 2 ml otopine, u kutiji	HR-H-120966702-04	Never marketed	-
20 ampula s 2 ml otopine, u kutiji	HR-H-120966702-05	Never marketed	-
25 ampula s 2 ml otopine, u kutiji	HR-H-120966702-06	Never marketed	-
30 ampula s 2 ml otopine, u kutiji	HR-H-120966702-07	Never marketed	-
35 ampula s 2 ml otopine, u kutiji	HR-H-120966702-08	Never marketed	-
40 ampula s 2 ml otopine, u kutiji	HR-H-120966702-09	Never marketed	-
45 ampula s 2 ml otopine, u kutiji	HR-H-120966702-10	Never marketed	-
50 ampula s 2 ml otopine, u kutiji	HR-H-120966702-11	-	-
55 ampula s 2 ml otopine, u kutiji	HR-H-120966702-12	-	-
60 ampula s 2 ml otopine, u kutiji	HR-H-120966702-13	-	-
65 ampula s 2 ml otopine, u kutiji	HR-H-120966702-14	-	-
70 ampula s 2 ml otopine, u kutiji	HR-H-120966702-15	-	-
75 ampula s 2 ml otopine, u kutiji	HR-H-120966702-16	-	-
80 ampula s 2 ml otopine, u kutiji	HR-H-120966702-17	-	-
85 ampula s 2 ml otopine, u kutiji	HR-H-120966702-18	-	-
90 ampula s 2 ml otopine, u kutiji	HR-H-120966702-19	-	-
95 ampula s 2 ml otopine, u kutiji	HR-H-120966702-20	-	-
100 ampula s 2 ml otopine, u kutiji	HR-H-120966702-21	-	-
1 ampula s 5 ml otopine, u kutiji	HR-H-120966702-22	-	-
5 ampula s 5 ml otopine, u kutiji	HR-H-120966702-23	-	-
10 ampula s 5 ml otopine, u kutiji	HR-H-120966702-24	-	-
15 ampula s 5 ml otopine, u kutiji	HR-H-120966702-25	-	-
20 ampula s 5 ml otopine, u kutiji	HR-H-120966702-26	-	-
25 ampula s 5 ml otopine, u kutiji	HR-H-120966702-27	-	-
30 ampula s 5 ml otopine, u kutiji	HR-H-120966702-28	-	-
35 ampula s 5 ml otopine, u kutiji	HR-H-120966702-29	-	-
40 ampula s 5 ml otopine, u kutiji	HR-H-120966702-30	-	-
45 ampula s 5 ml otopine, u kutiji	HR-H-120966702-31	-	-
50 ampula s 5 ml otopine, u kutiji	HR-H-120966702-32	-	-
55 ampula s 5 ml otopine, u kutiji	HR-H-120966702-33	-	-
60 ampula s 5 ml otopine, u kutiji	HR-H-120966702-34	-	-
65 ampula s 5 ml otopine, u kutiji	HR-H-120966702-35	-	-
70 ampula s 5 ml otopine, u kutiji	HR-H-120966702-36	-	-
75 ampula s 5 ml otopine, u kutiji	HR-H-120966702-37	-	-
80 ampula s 5 ml otopine, u kutiji	HR-H-120966702-38	-	-
85 ampula s 5 ml otopine, u kutiji	HR-H-120966702-39	-	-
90 ampula s 5 ml otopine, u kutiji	HR-H-120966702-40	-	-
95 ampula s 5 ml otopine, u kutiji	HR-H-120966702-41	-	-
100 ampula s 5 ml otopine, u kutiji	HR-H-120966702-42	-	-
1 ampula s 10 ml otopine, u kutiji	HR-H-120966702-43	-	-
5 ampula s 10 ml otopine, u kutiji	HR-H-120966702-44	-	-
10 ampula s 10 ml otopine, u kutiji	HR-H-120966702-45	-	-
15 ampula s 10 ml otopine, u kutiji	HR-H-120966702-46	-	-
20 ampula s 10 ml otopine, u kutiji	HR-H-120966702-47	-	-
25 ampula s 10 ml otopine, u kutiji	HR-H-120966702-48	-	-
30 ampula s 10 ml otopine, u kutiji	HR-H-120966702-49	-	-
35 ampula s 10 ml otopine, u kutiji	HR-H-120966702-50	-	-
40 ampula s 10 ml otopine, u kutiji	HR-H-120966702-51	-	-
45 ampula s 10 ml otopine, u kutiji	HR-H-120966702-52	-	-
50 ampula s 10 ml otopine, u kutiji	HR-H-120966702-53	-	-
55 ampula s 10 ml otopine, u kutiji	HR-H-120966702-54	-	-
60 ampula s 10 ml otopine, u kutiji	HR-H-120966702-55	-	-
65 ampula s 10 ml otopine, u kutiji	HR-H-120966702-56	-	-
70 ampula s 10 ml otopine, u kutiji	HR-H-120966702-57	-	-
75 ampula s 10 ml otopine, u kutiji	HR-H-120966702-58	-	-
80 ampula s 10 ml otopine, u kutiji	HR-H-120966702-59	-	-
85 ampula s 10 ml otopine, u kutiji	HR-H-120966702-60	-	-
90 ampula s 10 ml otopine, u kutiji	HR-H-120966702-61	-	-
95 ampula s 10 ml otopine, u kutiji	HR-H-120966702-62	-	-
100 ampula s 10 ml otopine, u kutiji	HR-H-120966702-63	-	-