Spevigo

Medicinal product

(Invented) name

Spevigo

Active substance (s)

Spesolimabas

Strength

150 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)

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

Užpildytame švirkšte (1 ml) tirpalo yra	1 ml
Spesolimabas	150 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
115195	101304	1101304	užpildytas švirkštas	N2		Receptinis	EU/1/22/1688/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-09	Registruotas