Braftovi

Medicinal product

(Invented) name

Braftovi

Active substance (s)

Enkorafenibas

Strength

75 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)

L01EC03, encorafenib

Marketing authorisation holder

Pierre Fabre Medicament, Prancūzija

Date of authorisation

2018-09-20

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

Capsule, hard	1 vnt.
Enkorafenibas	75 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
100129	86238	1086238	dalomoji lizdinė plokštelė	N42x1		Receptinis	EU/1/18/1314/002	Netiekiama	-	2026-07-01	Yes	2026-05-08	2026-06-30
101620	87724	1087724	dalomoji lizdinė plokštelė	N168x1		Receptinis	EU/1/18/1314/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-20	Registruotas