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Medicines
Netherlands
Darifenacin

CBG-MEB 2004

Darifenacin

Emselex 15 mg, tabletten met verlengde afgifte

Tablet met verlengde afgifteNetherlandsAuthorisedAuthorised 22 Oct 2004

Product informationAsk Osler about it

On this page

In other countries
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

EmselexEuropean UnionAuthorised

EmselexEuropean Union · pharmaand GmbHSame brand
EmselexCroatiaSame brand
Apo-DarifenacinCanada · 15 MG · Tablet (Extended-Release) · Apotex INCSame form
Apo-DarifenacinCanada · 7.5 MG · Tablet (Extended-Release) · Apotex INCSame form
EnablexCanada · 7.5 MG · Tablet (Extended-Release) · Searchlight Pharma INCSame form
Darifenacina Aristo 15 MG Comprimidos de Liberacion Prolongada EfgSpain · 17,846 mg · comprimido de liberación prolongada · Aristo Pharma Gmbh

More with the same substance on this register

Darifenacine Aristo 15 mg tabletten met verlengde afgifteDarifenacin · Tablet met verlengde afgifteNetherlands
Darifenacine Aristo 7,5 mg tabletten met verlengde afgifteDarifenacin · Tablet met verlengde afgifte

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same form

🇪🇸Darifenacina Aristo 7,5 MG Comprimidos de Liberacion Prolongada EfgSpain · 8,923 mg · comprimido de liberación prolongada · Aristo Pharma GmbhSame form

🇷🇸Darifenacin AristoSerbia · 15mg · tableta sa produženim oslobađanjem · PredstavniŠTvo Aristo Pharma GMBH NiŠ-MedijanaSame form

🇷🇸Darifenacin AristoSerbia · 7.5mg · tableta sa produženim oslobađanjem · PredstavniŠTvo Aristo Pharma GMBH NiŠ-MedijanaSame form

🇸🇦Enablex 15MG Prolonged Release TabletsSaudi Arabia · NovartisSame form

🇸🇦Enablex 15MG Prolonged Release TabletsSaudi Arabia · ASPEN Bad Oldesloe GmbHSame form

🇸🇦Enablex 7.5MG Prolonged Release TabletsSaudi Arabia · ASPEN Bad Oldesloe GmbHSame form

🇺🇸DarifenacinUnited States · 15MG BASE, 7.5MG BASE · tablet, extended release · Macleods Pharms LTDSame form

🇺🇸Darifenacin HydrobromideUnited States · 15MG BASE, 7.5MG BASE · tablet, extended release · Puracap Labs BluSame form

🇺🇸EnablexUnited States · 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release · AbbvieSame form

🇧🇷Bromidrato de DarifenacinaBrazil · Adium S.A.Same substance

🇧🇷EnablexBrazil · Aspen Pharma Indústria Farmacêutica LtdaSame substance

🇧🇷FenazicBrazil · Adium S.A.Same substance

Documents

The official texts, at the regulator.

Summary of product characteristicsCBG-MEB
Register entryCBG-MEB

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Darifenacin
Dosage form: Tablet met verlengde afgifte
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 22 Oct 2004
Registration: EU/1/04/294
Marketing authorisation holder: zr pharma& GmbH
ATC code: G04BD10
Group: Genito-urinary system and sex hormones
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/000554
EU number: EU/1/04/294

🇳🇱Netherlands

CBG-MEBEmselex 7,5 mg, tabletten met verlengde afgifteDarifenacin · Tablet met verlengde afgifte🇳🇱Netherlands