Rezdiffra

Medicinal product

(Invented) name

Rezdiffra

Active substance (s)

Resmetiromas

Strength

100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XH07, resminostat

Marketing authorisation holder

Madrigal Pharmaceuticals EU Limited, Airija

Date of authorisation

2025-08-18

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

Tabletėje yra:	1 vnt.
Resmetiromas	100 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
118405	104511	1104511	lizdinė plokštelė	N28		Receptinis	EU/1/25/1962/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-18	Registruotas