Xermelo

Medicinal product

(Invented) name

Xermelo

Active substance (s)

Telotristato etilas

Strength

250 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)

A07XA05, Telotristat

Marketing authorisation holder

SERB SAS, Prancūzija

Date of authorisation

2017-09-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

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.
Telotristato etilas	250 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
97850	83945	1083945	lizdinė plokštelė	N90		Receptinis	EU/1/17/1224/001	Netiekiama	-	-	No	-	-
97851	83946	1083946	lizdinė plokštelė	N180		Receptinis	EU/1/17/1224/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas