Litfulo

Medicinal product

(Invented) name

Litfulo

Active substance (s)

Ritlecitinibas

Strength

50 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)

L04AF08, ritlecitinib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2023-09-15

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.
Ritlecitinibas	50 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
111612	97725	1097725	buteliukas	N28		Receptinis	EU/1/23/1755/001	Netiekiama	-	-	No	-	-
111613	97726	1097726	lizdinė plokštelė	N30		Receptinis	EU/1/23/1755/002	Netiekiama	-	-	No	-	-
111614	97727	1097727	lizdinė plokštelė	N90		Receptinis	EU/1/23/1755/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas