Samsca

Medicinal product

(Invented) name

Samsca

Active substance (s)

Tolvaptanas

Strength

7,5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C03XA01, Tolvaptan

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V., Nyderlandai

Date of authorisation

2009-08-03

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

Tablet	1 vnt.
Tolvaptanas	7,5 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
97912	84008	1084008	dalomoji lizdinė plokštelė	N10x1 (PP/alu)		Receptinis	EU/1/09/539/005	Netiekiama	-	-	No	-	-
97913	84009	1084009	dalomoji lizdinė plokštelė	N30x1 (PP/alu)		Receptinis	EU/1/09/539/006	Netiekiama	-	-	No	-	-
100281	86390	1086390	dalomoji lizdinė plokštelė	N10x1 (PVC/alu)		Receptinis	EU/1/09/539/007	Netiekiama	-	-	No	-	-
100282	86391	1086391	dalomoji lizdinė plokštelė	N30x1 (PVC/alu)		Receptinis	EU/1/09/539/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-08-03	Registruotas