Tolvaptan Accord

Medicinal product

(Invented) name

Tolvaptan Accord

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

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	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
110921	97032	1097032	dalomoji lizdinė plokštelė	N7×1		Receptinis	EU/1/23/1719/005	Netiekiama	-	-	No	-	-
110922	97033	1097033	dalomoji lizdinė plokštelė	N10×1		Receptinis	EU/1/23/1719/006	Netiekiama	-	-	No	-	-
110923	97034	1097034	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/23/1719/007	Netiekiama	-	-	No	-	-
110924	97035	1097035	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/23/1719/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-24	Registruotas