Sycrest

Medicinal product

(Invented) name

Sycrest

Active substance (s)

Azenapinas

Strength

10 mg

Pharmaceutical form

poliežuvinės tabletės

Route (s) of administration

vartoti po liežuviu

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH05, Asenapine

Marketing authorisation holder

Organon N.V., Nyderlandai

Date of authorisation

2010-09-01

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

Sublingual tablet	1 vnt.
Azenapinas	10 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
42631	56399	1056399	lizdinė plokštelė	N20		Receptinis	EU/1/10/640/004	Netiekiama	-	-	No	-	-
42632	56400	1056400	lizdinė plokštelė	N60		Receptinis	EU/1/10/640/005	Netiekiama	-	-	No	-	-
42633	56401	1056401	lizdinė plokštelė	N100		Receptinis	EU/1/10/640/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-09-01	Registruotas