Details

Product Name in the RMS: Spiolto Respimat

MR Number: NL/H/3157/001
Date of outcome: 20.05.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only
Active Substances	olodaterol 2,5 mg/dose tiotropium bromide 2,5 mg/dose
Form	Inhalation solution
MA Holder in the RMS	Boerhinger Ingelheim International GmBH/DE
RMS	Netherlands
Date of last change	12.07.2018
ATC-Code	R03A ADRENERGICS, INHALANTS

CMS Country	Domestic Product Name
Austria	Spiolto Respimat 2,5 Mikrogramm/2,5 Mikrogramm Inhalationslösung
Belgium	Spiolto Respimat 2,5 microgrammes/2,5 microgrammes/inhalation, solution à inhaler
Bulgaria	Spiolto Respimat
Croatia	Spiolto Respimat 2,5 mikrograma/2,5 mikrograma, otopina inhalata
Cyprus	SPIOLTO RESPIMAT INHALATION SOL
Czech Republic	Spiolto Respimat 2,5 mikrogramů/ 2,5 mikrogramů
Denmark	Spiolto Respimat
Estonia	SPIOLTO RESPIMAT
Finland
France
Germany	Spiolto Respimat 2,5 Mikrogramm /2,5 Mikrogramm pro Hub Lösung zur Inhalation
Greece	SPIOLTO® RESPIMAT
Hungary
Iceland	Spiolto Respimat 2,5/2,5 míkróg Innöndunarlausn
Ireland
Italy
Latvia	Spiolto Respimat 2,5 mikrogrami/2,5 mikrogrami šķīdums inhalācijām
Liechtenstein
Lithuania	Spiolto Respimat 2,5 mikrogramo/2,5 mikrogramo/išpurškime įkvepiamasis tirpalas
Luxembourg	Spioloto Respimat Solution pour inhalation en flacon pressurisé
Malta	Spiolto Respimat
Norway
Poland
Portugal
Romania	Spiolto Respimat
Slovak Republic	Spiolto Respimat 2,5 mikrogramu/2,5 mikrogramu inhalačný roztok
Slovenia
Spain
Sweden
United Kingdom

Documents
PAR:	NL_H_3157_001_PAR.pdf (20.07.2015)
PARSummary:	NL_H_3157_001_PARSummary.pdf (20.07.2015)
Finalised Product Information:	NL_H_3157_001_FinalPI.pdf (11.03.2016)