Constella

Medicinal product

(Invented) name

Constella

Active substance (s)

Linaklotidas

Strength

290 µg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A06AX04, Linaclotide

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2012-11-26

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

Capsules, hard	1 vnt.
Linaklotidas	290 µg

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
54552	68549	1068549	buteliukas	N10		Receptinis	EU/1/12/801/001	Netiekiama	-	-	No	-	-
54553	68550	1068550	buteliukas	N28		Receptinis	EU/1/12/801/002	Netiekiama	-	-	No	-	-
54555	68552	1068552	buteliukas	N90		Receptinis	EU/1/12/801/004	Netiekiama	-	-	No	-	-
97840	83935	1083935	buteliukas	N112 (4x28)		Receptinis	EU/1/12/801/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-11-26	Registruotas