Gopten

Medicinal product

(Invented) name

Gopten

Active substance (s)

Trandolaprilis

Strength

2 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09AA10, Trandolapril

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2025-06-26

Date of renewal

Documents

2660_Gopten 2 mg kietosios kapsulės_PL_2025-06-26.docx

2660_Gopten 2 mg kietosios kapsulės_PZ_2025-06-26.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Trandolaprilis	2 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
117876	103981	1103981	lizdinė plokštelė	N28		Receptinis	LT/L/25/2660/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-06-26	Registruotas