ASPAVELI

Medicinal product

(Invented) name

ASPAVELI

Active substance (s)

Pegcetakoplanas

Strength

1080 mg

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ03, pegcetacoplan

Marketing authorisation holder

Swedish Orphan Biovitrum AB (publ), Švedija

Date of authorisation

2021-12-13

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

Flakone (20 ml) tirpalo yra:	20 ml
Pegcetakoplanas	1080 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
107741	93846	1093846	flakonas	N1		Receptinis	EU/1/21/1595/001	Netiekiama	-	-	No	-	-
107742	93847	1093847	flakonas	N8 (8×1)		Receptinis	EU/1/21/1595/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-13	Registruotas