Tolvaptan Accord

Medicinal product

(Invented) name

Tolvaptan Accord

Active substance (s)

Tolvaptanas

Strength

30 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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2023-04-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tablet	1 vnt.
Tolvaptanas	30 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
110925	97036	1097036	dalomoji lizdinė plokštelė	N7×1		Receptinis	EU/1/23/1719/009	Netiekiama	-	-	No	-	-
110926	97037	1097037	dalomoji lizdinė plokštelė	N10×1		Receptinis	EU/1/23/1719/010	Netiekiama	-	-	No	-	-
110927	97038	1097038	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/23/1719/011	Netiekiama	-	-	No	-	-
110928	97039	1097039	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/23/1719/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-24	Registruotas