ROMVIMZA

Medicinal product

(Invented) name

ROMVIMZA

Active substance (s)

Vimseltinibas

Strength

14 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01EX29, vimseltinib

Marketing authorisation holder

Deciphera Pharmaceuticals (Netherlands) B.V., Nyderlandai

Date of authorisation

2025-09-17

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Vimseltinibas	14 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
118818	104925	1104925	lizdinė plokštelė	N8		Receptinis	EU/1/25/1968/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-17	Registruotas