Tolvaptan Accord

Medicinal product

(Invented) name

Tolvaptan Accord

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

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	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
110917	97028	1097028	dalomoji lizdinė plokštelė	N7×1		Receptinis	EU/1/23/1719/001	Netiekiama	-	-	No	-	-
110918	97029	1097029	dalomoji lizdinė plokštelė	N10×1		Receptinis	EU/1/23/1719/002	Netiekiama	-	-	No	-	-
110919	97030	1097030	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/23/1719/003	Netiekiama	-	-	No	-	-
110920	97031	1097031	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/23/1719/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-24	Registruotas