Enspryng

Medicinal product

(Invented) name

Enspryng

Active substance (s)

Satralizumabas

Strength

120 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)

L04AC19, satralizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2021-06-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Užpildytame švirkštiklyje (1 ml tirpalo) yra	1 ml
Satralizumabas	120 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
122081	108190	1108190	užpildytas švirkštiklis	1 ml N1		Receptinis	EU/1/21/1559/003	Netiekiama	-	-	No	-	-
122082	108191	1108191	užpildytas švirkštiklis	1 ml N3		Receptinis	EU/1/21/1559/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-24	Registruotas