Valcyte

Medicinal product

(Invented) name

Valcyte

Active substance (s)

Valgancikloviras

Strength

450 mg

Pharmaceutical form

plėvele dengtos tabletės

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

2006-03-09

Date of renewal

2013-12-27

Documents

0386 Pakuotės lapelis 2022 08 23.docx

0386 Valcyte tab II PL 2022 08 23.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0323/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Valgancikloviras	450 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
13798	4609	1004609	buteliukas	N60		Receptinis	LT/1/05/0386/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-12-01	Išregistruotas
2013-12-27	Perregistruotas
2006-03-09	Registruotas