Entyvio

Medicinal product

(Invented) name

Entyvio

Active substance (s)

Vedolizumabas

Strength

108 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)

L04AG05, Vedolizumab

Marketing authorisation holder

Takeda Pharma A/S, Danija

Date of authorisation

2014-05-22

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

Solution for injection in pre-filled syringe	0.68 ml
Vedolizumabas	108 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
105152	91254	1091254	užpildytas švirkštas	N1		Receptinis	EU/1/14/923/002	Netiekiama	-	-	No	-	-
105153	91255	1091255	užpildytas švirkštas	N2 (2x1)		Receptinis	EU/1/14/923/003	Netiekiama	-	-	No	-	-
105154	91256	1091256	užpildytas švirkštas	N6 (6x1)		Receptinis	EU/1/14/923/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-05-22	Registruotas