Wakix

Medicinal product

(Invented) name

Wakix

Active substance (s)

Pitolizantas

Strength

18 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)

N07XX11, Pitolisant

Marketing authorisation holder

Bioprojet Pharma, Prancūzija

Date of authorisation

2016-03-31

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.
Pitolizantas	18 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
65518	80025	1080025	buteliukas	N30		Receptinis	EU/1/15/1068/002	Netiekiama	2024-07-02	2025-12-31	Yes	2025-07-02	2025-12-31
100789	86899	1086899	buteliukas	N90 (3x30) (sudėtinė)		Receptinis	EU/1/15/1068/003	Netiekiama	-	-	No	-	-
100790	86900	1086900	buteliukas	N90		Receptinis	EU/1/15/1068/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-31	Registruotas