Fluditec

Medicinal product

(Invented) name

Fluditec

Active substance (s)

Karbocisteinas

Strength

50 mg/ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB03, Carbocisteine

Marketing authorisation holder

Laboratoire Innotech International S.A.S., Prancūzija

Date of authorisation

1997-07-02

Date of renewal

2011-06-15

Documents

2513 Pakuotės lapelis 50mg 2025 07 29.docx

2513 Fluditec 50mg sirupas RPP 2025 07 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml sirupo yra	1 ml
Karbocisteinas	50 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
11493	15948	1015948	buteliukas	125 ml ir taurelė (20 ml) N1		Nereceptinis	LT/1/97/2513/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-15	Perregistruotas
1997-07-02	Registruotas