Vesicare

Medicinal product

(Invented) name

Vesicare

Active substance (s)

Solifenacino sukcinatas

Strength

1 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G04BD08, Solifenacin

Marketing authorisation holder

Astellas Pharma d.o.o., Slovėnija

Date of authorisation

2015-10-12

Date of renewal

2020-10-23

Documents

0465 Vesicare II PL 2024 04 01.docx

0465 Pakuotės lapelis 2024 04 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0487/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Solifenacino sukcinatas	1 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
60536	74815	1074815	buteliukas	150 ml N1		Receptinis	LT/1/05/0465/021	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-23	Perregistruotas
2015-10-12	Registruotas