Valcyte

Medicinal product

(Invented) name

Valcyte

Active substance (s)

Valgancikloviras

Strength

50 mg/ml

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AB14, Valganciclovir

Marketing authorisation holder

UAB Roche Lietuva, Lietuva

Date of authorisation

2008-05-12

Date of renewal

2013-06-07

Documents

1131 Pakuotės lapelis 2022 08 23.docx

1131 Valcyte milt ger tirp II PL 2022 08 23.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0323/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruošto tirpalo yra	1 ml
Valgancikloviras	50 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
20812	23760	1023760	buteliukas	milteliai (12 g), adapteris, 2 geriamieji švirkštai N1		Receptinis	LT/1/08/1131/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-01	Išregistruotas
2013-06-07	Perregistruotas
2008-05-12	Registruotas