Envarsus

Medicinal product

(Invented) name

Envarsus

Active substance (s)

Takrolimuzas

Strength

1 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	1 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
59781	74015	1074015	lizdinė plokštelė	N30		Receptinis	EU/1/14/935/004	Netiekiama	-	-	No	-	-
59782	74016	1074016	lizdinė plokštelė	N60		Receptinis	EU/1/14/935/005	Tiekiama	-	-	No	-	-
59783	74017	1074017	lizdinė plokštelė	N90		Receptinis	EU/1/14/935/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-07-18	Registruotas