Elmiron

Medicinal product

(Invented) name

Elmiron

Active substance (s)

Natrio pentozano polisulfatas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G04BX15, Pentosan polysulfate sodium

Marketing authorisation holder

bene-Arzneimittel GmbH, Vokietija

Date of authorisation

2017-06-02

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Natrio pentozano polisulfatas	100 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
68584	83165	1083165	buteliukas	N90		Receptinis	EU/1/17/1189/001	Netiekiama	2024-12-02	2026-07-09	Yes	2024-12-04	2025-12-02
68585	83166	1083166	lizdinė plokštelė	N90 (9x10)		Receptinis	EU/1/17/1189/002	Netiekiama	-	-	No	-	-
102197	88298	1088298	buteliukas	N300 (3x100)		Receptinis	EU/1/17/1189/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-02	Registruotas