Spevigo

Medicinal product

(Invented) name

Spevigo

Active substance (s)

Spesolimabas

Strength

450 mg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC22, spesolimab

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2022-12-09

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

Concentrate for solution for infusion	7.5 ml
Spesolimabas	450 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
110027	96136	1096136	flakonas	7,5 ml N2		Receptinis	EU/1/22/1688/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-09	Registruotas