EMSELEX

This brand name is authorized in Austria, Croatia, Cyprus, Estonia, Finland, Germany, Ireland, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, UK.

Active ingredients

The drug EMSELEX contains one active pharmaceutical ingredient (API):

1
UNII CR02EYQ8GV - DARIFENACIN HYDROBROMIDE
 

Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro. The M3 receptor is the major subtype that controls urinary bladder muscle contraction. It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome.

 
Read more about Darifenacin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EMSELEX Prolonged-release tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
G04BD10 Darifenacin G Genito urinary system and sex hormones → G04 Urologicals → G04B Other urologicals, incl. antispasmodics → G04BD Urinary antispasmodics
Discover more medicines within G04BD10

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
DE Bundesinstitut für Arzneimittel und Medizinprodukte 01754876, 01754899, 01754913, 01754994, 01755002, 01755019, 17421906, 17631118
EE Ravimiamet 1199998, 1200003, 1200014, 1200025, 1200036, 1200047, 1200058, 1200069, 1200070, 1200081, 1200092, 1200104, 1200115, 1200126
FI Lääkealan turvallisuus- ja kehittämiskeskus 023047, 023124, 023146, 023193
GB Medicines & Healthcare Products Regulatory Agency 109681, 109684, 367990, 367992, 374358, 374360, 376344, 376346, 381328, 381330
LT Valstybinė vaistų kontrolės tarnyba 1027975, 1027976, 1027977, 1027978, 1027979, 1027980, 1027981, 1027982, 1027983, 1027984, 1027985, 1027986, 1063750, 1063751, 1070290, 1070291, 1070292, 1070293, 1070294, 1070295, 1070296, 1070297, 1070298, 1070299, 1070300, 1070301, 1070302, 1070303
MX Comisión Federal para la Protección contra Riesgos Sanitarios 612M2005
NL Z-Index G-Standaard, PRK 78204, 78212
PL Rejestru Produktów Leczniczych 100129630, 100129647
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66045001, W66045002, W66045003, W66045004, W66045005, W66045006, W66046001, W66046002, W66046003, W66046004, W66046005, W66046006
TR İlaç ve Tıbbi Cihaz Kurumu 8699874080120, 8699874080137

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