ACC

Medicinal product

(Invented) name

ACC

Active substance (s)

Acetilcisteinas

Strength

20 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB01, Acetylcysteine

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2014-02-11

Date of renewal

2018-10-26

Documents

3507_1_2 ACC 20mg_ml ger tirp RPP 200312.docx

3507_1_2 Pakuotės lapelis 200312.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0177/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Acetilcisteinas	20 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
52614	66538	1066538	buteliukas	100 ml, geriamasis švirkštas ir matavimo taurelė N1		Nereceptinis	LT/1/14/3507/001	Netiekiama	2025-01-09	2025-10-31	No	-	-	Download
58511	72677	1072677	buteliukas	200 ml, geriamasis švirkštas ir matavimo taurelė N1		Nereceptinis	LT/1/14/3507/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-10-26	Perregistruotas
2014-02-11	Registruotas