Envarsus

Medicinal product

(Invented) name

Envarsus

Active substance (s)

Takrolimuzas

Strength

4 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 tablet	1 vnt.
Takrolimuzas	4 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
59784	74018	1074018	lizdinė plokštelė	N30		Receptinis	EU/1/14/935/007	Netiekiama	2025-07-30	2025-09-30	Yes	2025-08-01	2025-12-31
59785	74019	1074019	lizdinė plokštelė	N60		Receptinis	EU/1/14/935/008	Netiekiama	-	-	No	-	-
59786	74020	1074020	lizdinė plokštelė	N90		Receptinis	EU/1/14/935/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-07-18	Registruotas