Ezmekly

Medicinal product

(Invented) name

Ezmekly

Active substance (s)

Mirdametinibas

Strength

1 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EE05, mirdametinib

Marketing authorisation holder

SpringWorks Therapeutics Ireland Limited, Airija

Date of authorisation

2025-07-17

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

Kapsulėje yra	1 vnt.
Mirdametinibas	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
118122	104230	1104230	buteliukas	N42		Receptinis	EU/1/25/1950/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-17	Registruotas