Tolvaptan STADA

Medicinal product

(Invented) name

Tolvaptan STADA

Active substance (s)

Tolvaptanas+Tolvaptanas

Strength

15 mg + 45 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

6091-5_pakuotes lapelis_2026-07-17.doc

6091-95_Tolvaptan STADA.doc

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0718/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

15 mg tabletėje yra	1 vnt.
Tolvaptanas	15 mg
45 mg tabletėje yra	1 vnt.
Tolvaptanas	45 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
121680	107790	1107790	lizdinė plokštelė	N14 (N7×15 mg + N7×45 mg)		Receptinis	LT/1/26/6093/001	Netiekiama	-	-	No	-	-
121681	107791	1107791	lizdinė plokštelė	N28 (N14×15 mg + N14×45 mg)		Receptinis	LT/1/26/6093/002	Netiekiama	-	-	No	-	-
121682	107792	1107792	lizdinė plokštelė	N56 (N28×15 mg + 28×45 mg)		Receptinis	LT/1/26/6903/003	Netiekiama	-	2027-07-31	No	-	-

Stadijos

Data	Stadija
2026-07-17	Registruotas