Avtozma

Medicinal product

(Invented) name

Avtozma

Active substance (s)

Tocilizumabas

Strength

162 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 švirkštiklyje (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
116829	102933	1102933	užpildytas švirkštiklis	N1		Receptinis	EU/1/24/1896/010	Netiekiama	-	-	No	-	-
116830	102934	1102934	užpildytas švirkštiklis	N4		Receptinis	EU/1/24/1896/011	Netiekiama	-	-	No	-	-
116831	102935	1102935	užpildytas švirkštiklis	N12 (3×4)		Receptinis	EU/1/24/1896/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-14	Registruotas