Envarsus

Medicinal product

(Invented) name

Envarsus

Active substance (s)

Takrolimuzas

Strength

0,75 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

L04AD02, Tacrolimus

Marketing authorisation holder

Chiesi Farmaceutici S.p.A., Italija

Date of authorisation

2014-07-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release tablets	1 vnt.
Takrolimuzas	0,75 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
59778	74012	1074012	lizdinė plokštelė	N30		Receptinis	EU/1/14/935/001	Tiekiama	-	-	No	-	-
59779	74013	1074013	lizdinė plokštelė	N60		Receptinis	EU/1/14/935/002	Netiekiama	-	-	No	-	-
59780	74014	1074014	lizdinė plokštelė	N90		Receptinis	EU/1/14/935/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-07-18	Registruotas