Tolvaptan STADA

Medicinal product

(Invented) name

Tolvaptan STADA

Active substance (s)

Tolvaptanas+Tolvaptanas

Strength

30 mg + 60 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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2026-07-17

Date of renewal

Documents

6091-95_Tolvaptan STADA.doc

6091-5_pakuotes lapelis_2026-07-17.doc

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0718/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

30 mg tabletėje yra	1 vnt.
Tolvaptanas	30 mg
60 mg tabletėje yra	1 vnt.
Tolvaptanas	60 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
121684	107794	1107794	lizdinė plokštelė	N14 (N7×30 mg + N7×60 mg)		Receptinis	LT/1/26/6094/001	Netiekiama	-	-	No	-	-
121685	107795	1107795	lizdinė plokštelė	N28 (N14×30 mg + N14×60 mg)		Receptinis	LT/1/26/6094/002	Netiekiama	-	-	No	-	-
121686	107796	1107796	lizdinė plokštelė	N56 (N28×30 mg + N28×60 mg)		Receptinis	LT/1/26/6094/003	Netiekiama	-	2027-07-31	No	-	-

Stadijos

Data	Stadija
2026-07-17	Registruotas