Avtozma

Medicinal product

(Invented) name

Avtozma

Active substance (s)

Tocilizumabas

Strength

162 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC07, Tocilizumab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2025-02-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Užpildytame švirkšte (0,9 ml tirpalo) yra	0.9 ml
Tocilizumabas	162 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
116826	102930	1102930	užpildytas švirkštas	N1		Receptinis	EU/1/24/1896/007	Netiekiama	-	-	No	-	-
116827	102931	1102931	užpildytas švirkštas	N4		Receptinis	EU/1/24/1896/008	Netiekiama	-	-	No	-	-
116828	102932	1102932	užpildytas švirkštas	N12 (3×4)		Receptinis	EU/1/24/1896/009	Netiekiama	-	-	No	-	-
118853	104960	1104960	užpildytas švirkštas	N2		Receptinis	EU/1/24/1896/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-14	Registruotas