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 | 23.12.2020 |
ATC-Code |
R03A ADRENERGICS, INHALANTS |
CMS Country | Domestic Product Name |
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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 | SPIOLTO RESPIMAT 2,5 mikrogramm/2,5 mikrogramm, inhalációs oldat |
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 2,5 micrograme/2,5 micrograme soluţie de inhalat |
Slovak Republic | Spiolto Respimat 2,5 mikrogramu/2,5 mikrogramu inhalačný roztok |
Slovenia | |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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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 (23.12.2020) |