Enspryng

Medicinal product

(Invented) name

Enspryng

Active substance (s)

Satralizumabas

Strength

120 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)

L04AC19, satralizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2021-06-24

Date of renewal

Documents

Enspryng paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	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
106796	92899	1092899	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/21/1559/001	Tiekiama	-	-	No	-	-
107237	93341	1093341	užpildytas švirkštas	1 ml N3 (3x1)		Receptinis	EU/1/21/1559/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-24	Registruotas