RXULTI

Medicinal product

(Invented) name

RXULTI

Active substance (s)

Brekspiprazolas

Strength

1 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)

N05AX16, Brexpiprazole

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V., Nyderlandai

Date of authorisation

2018-07-26

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.
Brekspiprazolas	1 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
100109	86217	1086217	lizdinė plokštelė	N10		Receptinis	EU/1/18/1294/003	Netiekiama	-	-	No	-	-
100110	86218	1086218	lizdinė plokštelė	N28		Receptinis	EU/1/18/1294/004	Netiekiama	-	-	No	-	-
107708	93813	1093813	lizdinė plokštelė	N56		Receptinis	EU/1/18/1294/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas