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

Abacus Medicine A/S, Danija

Date of authorisation

2023-02-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

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
110659	96770	1096770	lizdinė plokštelė	N30		Receptinis	EU/1/14/935/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-16	Registruotas