ACC Direct

Medicinal product

(Invented) name

ACC Direct

Active substance (s)

Acetilcisteinas

Strength

600 mg

Pharmaceutical form

geriamieji milteliai paketėlyje

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

2017-07-10

Date of renewal

2022-11-08

Documents

4091_ pakuotes lapelis_2022-11-08..docx

4091_ ACC Direct_perr2022-11-08..docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3790/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename paketėlyje yra	1.6 g
Acetilcisteinas	600 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
68708	83291	1083291	paketėlis	1,6 g N8		Nereceptinis	LT/1/17/4091/001	Netiekiama	-	-	No	-	-
68709	83292	1083292	paketėlis	1,6 g N10		Nereceptinis	LT/1/17/4091/002	Netiekiama	-	-	No	-	-	Download
68710	83293	1083293	paketėlis	1,6 g N14		Nereceptinis	LT/1/17/4091/003	Netiekiama	-	-	No	-	-
68711	83294	1083294	paketėlis	1,6 g N20		Nereceptinis	LT/1/17/4091/004	Netiekiama	-	-	No	-	-
68712	83295	1083295	paketėlis	1,6 g N30		Nereceptinis	LT/1/17/4091/005	Netiekiama	-	-	No	-	-
68713	83296	1083296	paketėlis	1,6 g N60		Nereceptinis	LT/1/17/4091/006	Netiekiama	-	-	No	-	-
68714	83297	1083297	paketėlis	1,6 g N90		Nereceptinis	LT/1/17/4091/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-31	Išregistruotas
2022-11-08	Perregistruotas
2017-07-10	Registruotas