Silodosin ARISTO

Medicinal product

(Invented) name

Silodosin ARISTO

Active substance (s)

Silodozinas

Strength

8 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)

G04CA04, Silodosin

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2025-06-17

Date of renewal

Documents

2650_Silodosin_ARISTO_8mg_kietos_kaps_PZ_2025-06-17.docx

2649_2650_Silodosin_ARISTO_4mg_8mg_PIL_2025-06-17.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Silodozinas	8 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
117801	103905	1103905	lizdinė plokštelė	N30		Receptinis	LT/L/25/2650/001	Netiekiama	-	-	No	-	-	Download
117802	103906	1103906	lizdinė plokštelė	N50		Receptinis	LT/L/25/2650/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-17	Registruotas