ACC

Medicinal product

(Invented) name

ACC

Active substance (s)

Acetilcisteinas

Strength

600 mg

Pharmaceutical form

milteliai geriamajam tirpalui

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

2019-02-08

Documents

3507 Pakuotės lapelis 2024 02 29.docx

3507 ACC 600mg milt ger tirp PL 2024 02 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0176/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra	3 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
52615	66539	1066539	paketėlis	N6		Nereceptinis	LT/1/14/3507/003	Netiekiama	-	-	No	-	-
58512	72678	1072678	paketėlis	N10		Nereceptinis	LT/1/14/3507/004	Netiekiama	-	-	No	-	-
58513	72679	1072679	paketėlis	N20		Nereceptinis	LT/1/14/3507/005	Netiekiama	-	-	No	-	-
58514	72680	1072680	paketėlis	N30		Nereceptinis	LT/1/14/3507/006	Netiekiama	-	-	No	-	-
58515	72681	1072681	paketėlis	N60		Nereceptinis	LT/1/14/3507/007	Netiekiama	-	-	No	-	-
65004	79495	1079495	paketėlis	N90		Nereceptinis	LT/1/14/3507/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-08	Perregistruotas
2014-02-11	Registruotas