Valganciclovir Accord

Medicinal product

(Invented) name

Valganciclovir Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-04-29

Date of renewal

2021-10-26

Documents

3914 Pakuotės lapelis 2023 03 15.docx

3914 Valganciclovir Accord II PL 2023 03 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3314/001/DC

Marketing authorisation procedure

Decentralizuota 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
60169	74441	1074441	lizdinė plokštelė	N60		Receptinis	LT/1/16/3914/001	Tiekiama	-	-	No	-	-
60170	74442	1074442	buteliukas	N60		Receptinis	LT/1/16/3914/002	Netiekiama	-	-	No	-	-
98640	84744	1084744	lizdinė plokštelė	N30		Receptinis	LT/1/16/3914/003	Netiekiama	-	-	No	-	-
98641	84745	1084745	lizdinė plokštelė	N90		Receptinis	LT/1/16/3914/004	Netiekiama	-	-	No	-	-
98642	84746	1084746	lizdinė plokštelė	N120		Receptinis	LT/1/16/3914/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-26	Perregistruotas
2016-04-29	Registruotas