WELIREG

Medicinal product

(Invented) name

WELIREG

Active substance (s)

Belzutifanas

Strength

40 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)

L01XX74, belzutifan

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2025-02-12

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.
Belzutifanas	40 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
116651	102750	1102750	lizdinė plokštelė	N30		Receptinis	EU/1/24/1893/001	Netiekiama	-	-	No	-	-
116652	102751	1102751	lizdinė plokštelė	N90 (3×N30)		Receptinis	EU/1/24/1893/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-12	Registruotas