Lytgobi

Medicinal product

(Invented) name

Lytgobi

Active substance (s)

Futibatinibas

Strength

4 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)

L01EN04, futibatinib

Marketing authorisation holder

Taiho Pharma Netherlands B.V., Nyderlandai

Date of authorisation

2023-07-04

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

Film-coated tablet	1 vnt.
Futibatinibas	4 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
111252	97365	1097365	lizdinė plokštelė	N21		Receptinis	EU/1/23/1741/001	Netiekiama	-	-	No	-	-
111253	97366	1097366	lizdinė plokštelė	N28		Receptinis	EU/1/23/1741/002	Netiekiama	-	-	No	-	-
111254	97367	1097367	lizdinė plokštelė	N35		Receptinis	EU/1/23/1741/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-04	Registruotas