Details

Product Name in the RMS: Tiotropium bromide lnpresgo 18 microgram, inhalation powder, hard capsule

MR Number: NL/H/3137/001
Date of outcome: 24.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Multiple (Copy) Application Full Dossier Chemical Substance Prescription Only
Active Substances	tiotropium bromide 18 µg
Form	Inhalation powder, hard capsule
MA Holder in the RMS	Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein
RMS	Netherlands
Date of last change	31.08.2020
ATC-Code	R03BB04 Tiotropium bromide

CMS Country	Domestic Product Name
Austria	Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation
Belgium	Srivasso 18 microgrammes poudre pour inhalation en gélule
Bulgaria	Tiotropium bromide Inpresgo
Cyprus	Tiotropium bromide lnpresgo 18 microgram, inhalation powder, hard capsule
Czech Republic	Srivasso 18 mikrogramů
Denmark
Finland
Germany	Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation
Greece	SRIVASSO® GENAHALER (ex TIOTROPIUM BROMIDE/TIOVENT® INPRESGO)
Hungary	SRIVASSO 18 mikrogramm inhalációs por kemény kapszulában
Iceland	Srivasso 18 míkróg Innöndunarduft, hart hylki
Italy
Latvia
Liechtenstein
Lithuania	Srivasso 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės)
Luxembourg
Norway
Poland	Srivasso
Portugal
Romania	SRIVASSO 18 micrograme capsule cu pulbere de inhalat
Slovak Republic	Tiotropium bromide Inpresgo
Slovenia
Sweden
United Kingdom	Favynd Inpresgo 18 microgram, inhalatiepoeder in harde capsules

Documents
PAR:	NL_H_3137_001_PAR.pdf (04.02.2016)
PARSummary:	NL_H_3137_001_PARSummary.pdf (04.02.2016)
Finalised Product Information:	NL_H_3137_001_FinalPI.pdf (26.03.2020)