Samsca

Medicinal product

(Invented) name

Samsca

Active substance (s)

Tolvaptanas

Strength

15 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	15 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
37117	50736	1050736	dalomoji lizdinė plokštelė	N10×1		Receptinis	EU/1/09/539/001	Netiekiama	-	-	No	-	-
37118	50737	1050737	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/09/539/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-08-03	Registruotas