Relistor

Medicinal product

(Invented) name

Relistor

Active substance (s)

Metilnaltreksono bromidas

Strength

12 mg/0,6 ml

Pharmaceutical form

injekcinis tirpalas

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

Flakone (0,6 ml) yra	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
30836	33291	1033291	flakonas	0,6 ml (20 mg/ml) N1		Receptinis	EU/1/08/463/001	Netiekiama	-	-	No	-	-
30837	33292	1033292	flakonas	0,6 ml N2 (+2 švirkštai (1 ml) su įtraukiama injekcine adata + 4 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/08/463/002	Netiekiama	-	-	No	-	-
30838	33293	1033293	flakonas	0,6 ml N7 (+7 švirkštai (1 ml) su įtraukiama adata ir 14 alkoholiu suvilgytų tamponų)		Receptinis	EU/1/08/463/003	Tiekiama	-	-	No	-	-
115957	102058	1102058	flakonas	0,6 ml N2 (+2 švirkštai (1 ml) su apsaugine injekcine adata + 4 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/08/463/012	Netiekiama	-	-	No	-	-
115958	102059	1102059	flakonas	0,6 ml N7 (+7 švirkštai (1 ml) su apsaugine adata + 14 alkoholiu suvilgytų tamponų)		Receptinis	EU/1/08/463/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-02	Registruotas