Ketek

Medicinal product

(Invented) name

Ketek

Active substance (s)

Telitromicinas

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)

J01FA15, Telithromycin

Marketing authorisation holder

Aventis Pharma S.A., Prancūzija

Date of authorisation

2001-07-09

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Telitromicinas	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
1732	7425	1007425	lizdinė plokštelė	N10		Receptinis	EU/1/01/191/001	Netiekiama	-	-	No	-	-
8774	13469	1013469	lizdinė plokštelė	N14		Receptinis	EU/1/01/191/002	Netiekiama	-	-	No	-	-
8775	13470	1013470	lizdinė plokštelė	N20		Receptinis	EU/1/01/191/003	Netiekiama	-	-	No	-	-
8776	13471	1013471	lizdinė plokštelė	N100		Receptinis	EU/1/01/191/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-06-11	Išregistruotas
2001-07-09	Registruotas