Zolgensma

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Medicinal product

(Invented) name

Zolgensma

Active substance (s)

Onasemnogenas abeparvovekas

Strength

2x10(x13) vg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

M09AX09, Onasemnogene abeparvovec

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2020-05-18

Date of renewal

Documents

Zolgensma mokomoji medziaga sveikatos prieziuros specialistui.pdf

Zolgensma mokomoji medziaga paciento globejui.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	1 ml
Onasemnogenas abeparvovekas	2x10(x13) vg/ml

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
104096	90199	1090199	flakonas	8,3 ml N2	Receptinis	EU/1/20/1443/001	Netiekiama	-	-	No	-	-
104097	90200	1090200	flakonas	5,5 ml N2 + 8,3 ml N1	Receptinis	EU/1/20/1443/002	Netiekiama	-	-	No	-	-
104098	90201	1090201	flakonas	5,5 ml N1 + 8,3 ml N2	Receptinis	EU/1/20/1443/003	Netiekiama	-	-	No	-	-
104099	90202	1090202	flakonas	8,3 ml N3	Receptinis	EU/1/20/1443/004	Netiekiama	-	-	No	-	-
104100	90203	1090203	flakonas	5,5 ml N2 + 8,3 ml N2	Receptinis	EU/1/20/1443/005	Netiekiama	-	-	No	-	-
104101	90204	1090204	flakonas	5,5 ml N1 + 8,3 ml N3	Receptinis	EU/1/20/1443/006	Netiekiama	-	-	No	-	-
104102	90205	1090205	flakonas	8,3 ml N4	Receptinis	EU/1/20/1443/007	Netiekiama	-	-	No	-	-
104103	90206	1090206	flakonas	5,5 ml N2 + 8,3 ml N3	Receptinis	EU/1/20/1443/008	Netiekiama	-	-	No	-	-
104104	90207	1090207	flakonas	5,5 ml N1 + 8,3 ml N4	Receptinis	EU/1/20/1443/009	Netiekiama	-	-	No	-	-
104170	90273	1090273	flakonas	8,3 ml N5	Receptinis	EU/1/20/1443/010	Netiekiama	-	-	No	-	-
104171	90274	1090274	flakonas	5,5 ml N2 + 8,3 ml N4	Receptinis	EU/1/20/1443/011	Netiekiama	-	-	No	-	-
104172	90275	1090275	flakonas	5,5 ml N1 + 8,3 ml N5	Receptinis	EU/1/20/1443/012	Netiekiama	-	-	No	-	-
104173	90276	1090276	flakonas	8,3 ml N6	Receptinis	EU/1/20/1443/013	Netiekiama	-	-	No	-	-
104174	90277	1090277	flakonas	5,5 ml N2 + 8,3 ml N5	Receptinis	EU/1/20/1443/014	Netiekiama	-	-	No	-	-
104175	90279	1090279	flakonas	5,5 ml N1 + 8,3 ml N6	Receptinis	EU/1/20/1443/015	Netiekiama	-	-	No	-	-
104176	90280	1090280	flakonas	8,3 ml N7	Receptinis	EU/1/20/1443/016	Netiekiama	-	-	No	-	-
104177	90281	1090281	flakonas	5,5 ml N2 + 8,3 ml N6	Receptinis	EU/1/20/1443/017	Netiekiama	-	-	No	-	-
104178	90282	1090282	flakonas	5,5 ml N1 + 8,3 ml N7	Receptinis	EU/1/20/1443/018	Netiekiama	-	-	No	-	-
104179	90283	1090283	flakonas	8,3 ml N8	Receptinis	EU/1/20/1443/019	Netiekiama	-	-	No	-	-
104180	90284	1090284	flakonas	5,5 ml N2 + 8,3 ml N7	Receptinis	EU/1/20/1443/020	Netiekiama	-	-	No	-	-
104181	90285	1090285	flakonas	5,5 ml N1 + 8,3 ml N8	Receptinis	EU/1/20/1443/021	Netiekiama	-	-	No	-	-
104182	90286	1090286	flakonas	8,3 ml N9	Receptinis	EU/1/20/1443/022	Netiekiama	-	-	No	-	-
104183	90287	1090287	flakonas	5,5 ml N2 + 8,3 ml N8	Receptinis	EU/1/20/1443/023	Netiekiama	-	-	No	-	-
104184	90288	1090288	flakonas	5,5 ml N1 + 8,3 ml N9	Receptinis	EU/1/20/1443/024	Netiekiama	-	-	No	-	-
104185	90289	1090289	flakonas	8,3 ml N10	Receptinis	EU/1/20/1443/025	Netiekiama	-	-	No	-	-
104186	90290	1090290	flakonas	5,5 ml N2 + 8,3 ml N9	Receptinis	EU/1/20/1443/026	Netiekiama	-	-	No	-	-
104187	90291	1090291	flakonas	5,5 ml N1 + 8,3 ml N10	Receptinis	EU/1/20/1443/027	Netiekiama	-	-	No	-	-
104188	90292	1090292	flakonas	8,3 ml N11	Receptinis	EU/1/20/1443/028	Netiekiama	-	-	No	-	-
104189	90293	1090293	flakonas	5,5 ml N2 + 8,3 ml N10	Receptinis	EU/1/20/1443/029	Netiekiama	-	-	No	-	-
104190	90294	1090294	flakonas	5,5 ml N1 + 8,3 ml N11	Receptinis	EU/1/20/1443/030	Netiekiama	-	-	No	-	-
104191	90295	1090295	flakonas	8,3 ml N12	Receptinis	EU/1/20/1443/031	Netiekiama	-	-	No	-	-
104192	90296	1090296	flakonas	5,5 ml N2 + 8,3 ml N11	Receptinis	EU/1/20/1443/032	Netiekiama	-	-	No	-	-
104193	90297	1090297	flakonas	5,5 ml N1 + 8,3 ml N12	Receptinis	EU/1/20/1443/033	Netiekiama	-	-	No	-	-
104194	90298	1090298	flakonas	8,3 ml N13	Receptinis	EU/1/20/1443/034	Netiekiama	-	-	No	-	-
104195	90299	1090299	flakonas	5,5 ml N2 + 8,3 ml N12	Receptinis	EU/1/20/1443/035	Netiekiama	-	-	No	-	-
104196	90300	1090300	flakonas	5,5 ml N1 + 8,3 ml N13	Receptinis	EU/1/20/1443/036	Netiekiama	-	-	No	-	-
104197	90301	1090301	flakonas	8,3 ml N14	Receptinis	EU/1/20/1443/037	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-18	Registruotas