Entyvio

Medicinal product

(Invented) name

Entyvio

Active substance (s)

Vedolizumabas

Strength

108 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	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
105155	91257	1091257	užpildytas švirkštiklis	N1		Receptinis	EU/1/14/923/005	Netiekiama	-	-	No	-	-
105156	91258	1091258	užpildytas švirkštiklis	N2 (2x1)		Receptinis	EU/1/14/923/006	Tiekiama	-	-	No	-	-
105157	91259	1091259	užpildytas švirkštiklis	N6 (6x1)		Receptinis	EU/1/14/923/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-05-22	Registruotas