EMB-Fatol

Medicinal product

(Invented) name

EMB-Fatol

Active substance (s)

Etambutolis

Strength

400 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J04AK02, Ethambutol

Marketing authorisation holder

Esteve Pharmaceuticals GmbH, Vokietija

Date of authorisation

1997-10-01

Date of renewal

2014-04-22

Documents

3544 Pakuotės lapelis 2024 10 22.docx

3544 EMB_Fatol PCS PL 2024 10 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Etambutolis	400 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
11847	695	1000695	buteliukas	N100		Receptinis	LT/1/97/3544/001	Tiekiama	-	-	No	-	-
11848	16283	1016283	buteliukas	N1000		Receptinis	LT/1/97/3544/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-04-22	Perregistruotas
1997-10-01	Registruotas