Relistor

Medicinal product

(Invented) name

Relistor

Active substance (s)

Metilnaltreksono bromidas

Strength

12 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	0.6 ml
Metilnaltreksono bromidas	12 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
42743	56511	1056511	užpildytas švirkštas	N4		Receptinis	EU/1/08/463/008	Netiekiama	-	-	No	-	-
42744	56512	1056512	užpildytas švirkštas	N7		Receptinis	EU/1/08/463/009	Netiekiama	-	-	No	-	-
42745	56513	1056513	užpildytas švirkštas	N8		Receptinis	EU/1/08/463/010	Netiekiama	-	-	No	-	-
42746	56514	1056514	užpildytas švirkštas	N10		Receptinis	EU/1/08/463/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-02	Registruotas