Rezdiffra

Medicinal product

(Invented) name

Rezdiffra

Active substance (s)

Resmetiromas

Strength

80 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

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Resmetiromas	80 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
118406	104512	1104512	lizdinė plokštelė	N28		Receptinis	EU/1/25/1962/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-18	Registruotas