Aciclovir Baxter

Medicinal product

(Invented) name

Aciclovir Baxter

Active substance (s)

Acikloviras

Strength

25 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AB01, Aciclovir

Marketing authorisation holder

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2013-02-08

Date of renewal

2018-09-10

Documents

3194 Aciclovir Baxter konc inf II PL 2021 09 30.docx

3194 Pakuotės lapelis 2021 09 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

IE/H/0869/001/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 mililitre tirpalo yra	1 ml
Acikloviras	25 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
48193	62018	1062018	flakonas	10 ml N5		Receptinis	LT/1/13/3194/001	Tiekiama	-	-	No	-	-	Download
48194	62019	1062019	flakonas	10 ml N10		Receptinis	LT/1/13/3194/002	Netiekiama	-	-	No	-	-
55120	69153	1069153	flakonas	10 ml N20		Receptinis	LT/1/13/3194/003	Netiekiama	-	-	No	-	-
55121	69154	1069154	flakonas	20 ml N5		Receptinis	LT/1/13/3194/004	Netiekiama	-	-	No	-	-
55122	69155	1069155	flakonas	20 ml N10		Receptinis	LT/1/13/3194/005	Netiekiama	-	-	No	-	-
55123	69156	1069156	flakonas	20 ml N20		Receptinis	LT/1/13/3194/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-10	Perregistruotas
2013-02-08	Registruotas