Relistor

Medicinal product

(Invented) name

Relistor

Active substance (s)

Metilnaltreksono bromidas

Strength

8 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A06AH01, Methylnaltrexone bromide

Marketing authorisation holder

Bausch Health Ireland Limited, Airija

Date of authorisation

2008-07-02

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

Solution for injection in pre-filled syringe	0.4 ml
Metilnaltreksono bromidas	8 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
42739	56507	1056507	užpildytas švirkštas	N4		Receptinis	EU/1/08/463/004	Netiekiama	-	-	No	-	-
42740	56508	1056508	užpildytas švirkštas	N7		Receptinis	EU/1/08/463/005	Netiekiama	-	-	No	-	-
42741	56509	1056509	užpildytas švirkštas	N8		Receptinis	EU/1/08/463/006	Netiekiama	-	-	No	-	-
42742	56510	1056510	užpildytas švirkštas	N10		Receptinis	EU/1/08/463/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-02	Registruotas