9 June 2017 EMA/356882/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: tiotropium
Procedure no.: PSUSA/00002972/201610
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPIRIVA RESPIMAT 2,5
NL/H/0718/001
22537
BOEHRINGER INGELHEIM
FI
mikrogram,
INTERNATIONAL GMBH
inhalationsvätska, lösning Спирива Респимат 2,5
NL/H/0718/001
20110382
микрограма, разтвор за
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
инхалация Spiriva Respimat 2,5
NL/H/0718/001
H/07/01452/001
mikrogramov raztopina
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
za inhaliranje Spiriva Respimat 2,5
NL/H/0718/001
BE 316495
Mikrogramm, Lösung zur
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Inhalation SPIRIVA RESPIMAT 2,5
NL/H/0718/001
BE 316495
microgram,
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
inhalatieoplossing Spiriva Respimat 2,5
NL/H/0718/001
H/07/01452/004
mikrogramov raztopina
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
za inhaliranje Spiriva Respimat 2,5
NL/H/0718/001
H/07/01452/003
mikrogramov raztopina
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
za inhaliranje Spiriva Respimat 2,5
NL/H/0718/001
H/07/01452/002
mikrogramov raztopina
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
za inhaliranje Spiriva® Respimat 2,5
NL/H/0718/001
17959
μικρογραμμάρια, διάλυμα
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
για εισπνοή Spiriva® Respimat 2,5
NL/H/0718/001
μικρογραμμάρια, διάλυμα
61514/12
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
για εισπνοή List of nationally authorised medicinal products EMA/356882/2017
Page 2/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva Respimat 2,5
NL/H/0718/001
14/0315/07-S
BOEHRINGER INGELHEIM
SK
mikrogramov inhalačný
INTERNATIONAL GMBH
roztok Spiriva®Respimat 2,5
NL/H/0718/001
20301
μικρογραμμάρια,
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
εισπνεόμενο διάλυμα Spiriva Respimat, 2,5
NL/H/0718/001
744811
mikrogrammi,
BOEHRINGER INGELHEIM
EE
INTERNATIONAL GMBH
inhalatsioonilahus SPIRIVA RESPIMAT 2,5
NL/H/0718/001
69.589
microgramos, solución
BOEHRINGER INGELHEIM
ES
INTERNATIONAL GMBH
para inhalación Spiriva Respimat 2,5
NL/H/718/01/DC
OGYI-T-8632/03
mikrogramm inhalációs
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
oldat Spiriva® Respimat® 2,5
NL/H/0718/001
52523.00.01
Mikrogramm Lösung zur
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
Inhalation Spiriva® Respimat® 2,5
NL/H/0718/001
1-27222
Mikrogramm - Lösung zur
BOEHRINGER INGELHEIM
LI
INTERNATIONAL GMBH
Inhalation Spiriva® Respimat® 2,5
NL/H/0718/001
1-27222
Mikrogramm - Lösung zur
BOEHRINGER INGELHEIM
AT
INTERNATIONAL GMBH
Inhalation SPIRIVA RESPIMAT 2,5
NL/H/0718/001
mikrogramu, roztok k
14/666/07-C
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
inhalaci
List of nationally authorised medicinal products EMA/356882/2017
Page 3/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva Respimat 2,5
NL/H/0718/001
038880011
BOEHRINGER INGELHEIM
IT
microgrammi, soluzione
INTERNATIONAL GMBH
per inalazione Spiriva Respimat 2,5
NL/H/0718/001
038880023
microgrammi, soluzione
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
per inalazione Spiriva Respimat 2,5
NL/H/0718/001
038880035
microgrammi, soluzione
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
per inalazione Spiriva Respimat 2,5
NL/H/0718/001
038880047
microgrammi, soluzione
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
per inalazione Spiriva Respimat 2,5
NL/H/0718/001
22537
mikrog, inhalaationeste,
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
liuos Spiriva Respimat 2,5
NL/H/0718/001
LT/1/07/0923/001
mikrogramo/išpurškime
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
įkvepiamasis tirpalas Spiriva Respimat 2,5
NL/H/0718/001
LT/1/07/0923/002
mikrogramo/išpurškime
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
įkvepiamasis tirpalas Spiriva Respimat 2,5
NL/H/0718/001
LT/1/07/0923/003
mikrogramo/išpurškime
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
įkvepiamasis tirpalas Spiriva Respimat 2,5
NL/H/0718/001
mikrogramo/išpurškime
LT/1/07/0923/004
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
įkvepiamasis tirpalas
List of nationally authorised medicinal products EMA/356882/2017
Page 4/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 2,5 mikrogram
NL/H/0718/001
06-4361
BOEHRINGER INGELHEIM
NO
inhalasjonsvæske,
INTERNATIONAL GMBH
oppløsning SPIRIVA RESPIMAT 2.5
NL/H/0718/001
MA 211/00201
microgram, inhalation
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
solution SPIRIVA RESPIMAT 2,5
NL/H/0718/001
1151/08110041
microgrammes, solution à
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
inhaler Spiriva Respimat 2,5
NL/H/0718/001
1151/08110041
Mikrogramm, Lösung zur
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
Inhalation Spiriva Respimat 2,5
NL/H/0718/001
07-0241
mikrogrami šķīdums
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
inhalācijām Spiriva Respimat 2.5
NL/H/0718/001
PA 775/2/2
microgram, inhalation
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
solution Spiriva Respimat, 2,5
NL/H/0718/001
5114111
microgramas, solução
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
para inalação por nebulização Spiriva Respimat, 2,5
NL/H/0718/001
mikrograma/dawke
16125
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
odmierzona, roztwór do inhalacji
List of nationally authorised medicinal products EMA/356882/2017
Page 5/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva Respimat,
NL/H/0718/001
39853
BOEHRINGER INGELHEIM
DK
inhalationsvæske,
INTERNATIONAL GMBH
opløsning Спирива Респимат 2,5
NL/H/718/01/DC
20110382 (14.11.2012)
микрограма, разтвор за
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
инхалация Spiriva Respimat 2.5
NL/H/0718/001
PL 14598/0084
microgram, inhalation
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
solution Spiriva Respimat 2,5
NL/H/0718/001
34382
microgram,
BOEHRINGER INGELHEIM
NL
INTERNATIONAL GMBH
inhalatieoplossing Spiriva Respimat, 2,5
NL/H/0718/001
5116009
microgramas, solução
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
para inalação por nebulização Spiriva Respimat, 2,5
NL/H/0718/001
5116017
microgramas, solução
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
para inalação por nebulização Spiriva Respimat 2,5
NL/H/0718/001
24315
mikrogram,
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
inhalationsvätska, lösning Spiriva Respimat, 2,5
NL/H/0718/001
microgramas, solução
5116025
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
para inalação por nebulização
List of nationally authorised medicinal products EMA/356882/2017
Page 6/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva Respimat 2,5
NL/H/0718/001
5642/2013/01
BOEHRINGER INGELHEIM
RO
micrograme solutie de
INTERNATIONAL GMBH
inhalat Spiriva Respimat 2,5
NL/H/0718/001
5642/2013/02
micrograme solutie de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Spiriva Respimat 2,5
NL/H/0718/001
5642/2013/03
micrograme solutie de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Spiriva Respimat 2,5
NL/H/0718/001
5642/2013/04
micrograme solutie de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat SPIRIVA RESPIMAT 2,5
NL/H/0718/001
BE 316495
microgrammes, solution à
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
inhaler SPIRIVA RESPIMAT 2,5
NL/H/0718/001
34009 571 506 3 1
microgrammes/dose,
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
solution pour inhalation SPIRIVA RESPIMAT 2,5
NL/H/0718/001
IS/1/06/052/01
míkrógrömm,
BOEHRINGER INGELHEIM
IS
INTERNATIONAL GMBH
innöndunarlausn SPIRIVA RESPIMAT 2,5
NL/H/0718/001
34009 381 920 3 2
microgrammes/dose,
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
solution pour inhalation SPIRIVA RESPIMAT 2,5
NL/H/0718/001
microgrammes/dose,
34009 571 505 7 0
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
solution pour inhalation
List of nationally authorised medicinal products EMA/356882/2017
Page 7/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPIRIVA RESPIMAT 2,5
NL/H/0718/001
34009 571 508 6 0
BOEHRINGER INGELHEIM
FR
microgrammes/dose,
INTERNATIONAL GMBH
solution pour inhalation Gregal 10 microgram per
UK/H/5875/001
PL 00289/1957
TEVA UK LIMITED
UK
UK/H/5875/001
80980
RATIOPHARM ESPANA SA
ES
UK/H/5875/001
5687769
RATIOPHARM-COMERCIO E
PT
delivered dose inhalation powder, hard capsule Gregal 10 microgramos/dosis liberada polvo para inhalación (cápsula dura) Gregal, 10 microgramas por dose libertada, pó
INDUSTRIA DE PRODUTOS
para inalação, cápsula
FARMACEUTICOS LDA
Gregal, 10 microgramas
UK/H/5875/001
5687660
por dose libertada, pó para inalação, cápsula Spiriva 18 mikrogram,
RATIOPHARM-COMERCIO E
PT
INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA NL/H/0299/001
17061
inhalationspulver, hård
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
kapsel SPIRIVA 18 Mikrogramm
NL/H/0299/001
BE 236047
Hartkapsel mit Pulver zur
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Inhalation SPIRIVA 18 Mikrogramm
NL/H/0299/001
0944/08029707
Hartkapsel mit Pulver zur
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
Inhalation Spiriva 18 micrograme
NL/H/0299/001
capsule cu pulbere de
3790/2011/01
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat
List of nationally authorised medicinal products EMA/356882/2017
Page 8/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 18 microgramas,
NL/H/0299/001
3984481
BOEHRINGER INGELHEIM
PT
pó para inalação, cápsula Spiriva 18 microgramas,
INTERNATIONAL GMBH NL/H/0299/001
3984580
pó para inalação, cápsula Spiriva 18 microgramas,
NL/H/0299/001
3984689
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH NL/H/0299/001
5177381
pó para inalação, cápsula Spiriva 18 mikrogramov
PT
INTERNATIONAL GMBH
pó para inalação, cápsula Spiriva 18 microgramas,
BOEHRINGER INGELHEIM
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH NL/H/0299/001
H/02/02008/001
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule SPIRIVA® 18 microgram,
NL/H/0299/001
PL 14598/0062
inhalation powder, hard
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
capsule SPIRIVA® 18 microgram,
NL/H/0299/001
PA 775/2/1
inhalation powder, hard
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
capsule СПИРИВА 18
NL/H/0299/001
20020374
микрограма, прах за
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
инхалация, твърдa капсулa Spiriva 18 microgramas,
NL/H/0299/001
pó para inalação, cápsula
List of nationally authorised medicinal products EMA/356882/2017
3984184
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
Page 9/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPIRIVA 18 mikrog
NL/H/0299/001
17061
BOEHRINGER INGELHEIM
FI
inhalaatiojauhe, kapseli,
INTERNATIONAL GMBH
kova Spiriva 18 microgramas,
NL/H/0299/001
3984283
pó para inalação, cápsula Spiriva 18 microgramas,
PT
INTERNATIONAL GMBH NL/H/0299/001
3984382
pó para inalação, cápsula SPIRIVA 18
BOEHRINGER INGELHEIM
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH NL/H/0299/001
566 813.9
microgrammes poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule SPIRIVA 18
NL/H/0299/001
34009 368 692 0 2
microgrammes poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule SPIRIVA 18
NL/H/0299/001
34009 570 762 6 9
microgrammes poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule SPIRIVA 18
NL/H/0299/001
384 622.3
microgrammes poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/001
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogramų
NL/H/0299/001
įkvepiamieji milteliai
LT/1/02/1389/002
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės)
List of nationally authorised medicinal products EMA/356882/2017
Page 10/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/003
BOEHRINGER INGELHEIM
LT
įkvepiamieji milteliai
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/004
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/005
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/006
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogramų
NL/H/0299/001
LT/1/02/1389/007
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Spiriva 18 mikrogram
NL/H/0299/001
01-12293
inhalasjonspulver, hard
BOEHRINGER INGELHEIM
NO
INTERNATIONAL GMBH
kapsel SPIRIVA, 18
NL/H/0299/001
747811
mikrogrammi
BOEHRINGER INGELHEIM
EE
INTERNATIONAL GMBH
inhalatsioonipulber kõvakapslis SPIRIVA 18
NL/H/0299/001
67681
μικρογραμμάρια, κόνις για
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο SPIRIVA®, 18
NL/H/0299/001
μικρογραμμάρια, κόνις για
21138
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο
List of nationally authorised medicinal products EMA/356882/2017
Page 11/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 18 mikrogramov
NL/H/0299/001
14/0415/11-S
BOEHRINGER INGELHEIM
SK
inhalačný prášok v tvrdej
INTERNATIONAL GMBH
kapsule SPIRIVAÒ 18 microgram,
NL/H/0299/001
MA211/00301
inhalation powder, hard
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
capsule SPIRIVA 18 mikrogramů
NL/H/0299/001
14/174/02-C
prášek k inhalaci v tvrdé
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
tobolce Spiriva 18 mikrogramov
NL/H/0299/001
H/02/02008/003
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule Spiriva 18 mikrogramov
NL/H/0299/001
H/02/02008/002
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule Spiriva 18 mikrogramov
NL/H/0299/001
H/02/02008/007
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule Spiriva 18 mikrogramov
NL/H/0299/001
H/02/02008/006
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule Spiriva 18 mikrogramov
NL/H/0299/001
H/02/02008/005
prašek za inhaliranje,
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule Spiriva 18 mikrogramov
NL/H/0299/001
prašek za inhaliranje,
H/02/02008/004
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
trde kapsule
List of nationally authorised medicinal products EMA/356882/2017
Page 12/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPIRIVA 18 microgramos
NL/H/0299/001
64.796
BOEHRINGER INGELHEIM
ES
polvo para inhalación Spiriva,
INTERNATIONAL GMBH NL/H/0299/001
33279
inhalationspulver, hård
BOEHRINGER INGELHEIM
DK
INTERNATIONAL GMBH
kapsel Spiriva 18 míkrógrömm,
NL/H/0299/001
IS/1/02/008/01
innöndunarduft, hart
BOEHRINGER INGELHEIM
IS
INTERNATIONAL GMBH
hylki SPIRIVA, 18 µg/dawke
not available
9851
inhalacyjna, proszek do
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
inhalacji w kapsulkach twardych SPIRIVA® 18
NL/H/299/01
1-24507
Mikrogramm - Kapseln
BOEHRINGER INGELHEIM
LI
INTERNATIONAL GMBH
mit Inhalationspulver Spiriva 18 mikrogramm
NL/H/0299/001
OGYI-T-8632/01
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában Spiriva 18 mikrogramm
NL/H/0299/001
OGYI-T-8632/02
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában Spiriva® 18 Mikrogramm
NL/H/0299/001
1-24507
- Kapseln mit
BOEHRINGER INGELHEIM
AT
INTERNATIONAL GMBH
Inhalationspulver SPIRIVA® 18
NL/H/0299/001
Mikrogramm Kapsel mit
52523.00.00
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
Inhalationspulver
List of nationally authorised medicinal products EMA/356882/2017
Page 13/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 18 microgram,
NL/H/0299/001
RVG 26191
BOEHRINGER INGELHEIM
NL
inhalatiepoeder in harde
INTERNATIONAL GMBH
capsules Spiriva 18 micrograme
NL/H/0299/001
3790/2011/01
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Spiriva 18 micrograme
NL/H/0299/001
3790/2011/02
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. Spiriva 18 micrograme
NL/H/0299/001
3790/2011/03
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. Spiriva 18 micrograme
NL/H/0299/001
3790/2011/04
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. Spiriva 18 micrograme
NL/H/0299/001
3790/2011/05
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. Spiriva 18 micrograme
NL/H/0299/001
3790/2011/06
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. Spiriva 18 micrograme
NL/H/0299/001
3790/2011/07
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat. SPIRIVA 18 mikrogram,
NL/H/0299/001
inhalationspulver, hård
18094
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
kapsel
List of nationally authorised medicinal products EMA/356882/2017
Page 14/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPIRIVA 18
NL/H/0299/001
0944/08029707
BOEHRINGER INGELHEIM
LU
microgrammes poudre
INTERNATIONAL GMBH
pour inhalation en gélule SPIRIVA 18
NL/H/0299/001
BE 236047
microgrammes poudre
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
pour inhalation en gélule SPIRIVA 18 MICROGRAM
NL/H/0299/001
BE 236047
INHALATIEPOEDER IN
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
HARDE CAPSULE Spiriva 18 microgrammi,
NL/H/0299/001
035668058
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Spiriva 18 microgrammi,
NL/H/0299/001
035668072
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Spiriva 18 microgrammi,
NL/H/0299/001
035668060
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Spiriva 18 microgrammi,
NL/H/0299/001
035668019
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Spiriva 18 microgrammi,
NL/H/0299/001
035668021
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Spiriva 18 microgrammi,
NL/H/0299/001
polvere per inalazione,
035668033
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida
List of nationally authorised medicinal products EMA/356882/2017
Page 15/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Spiriva 18 microgrammi,
NL/H/0299/001
035668045
BOEHRINGER INGELHEIM
IT
polvere per inalazione,
INTERNATIONAL GMBH
capsula rigida Spiriva 18 mikrograma,
not available
HR-H-342114823-02
prašak inhalata, tvrde
BOEHRINGER INGELHEIM
HR
ZAGREB D.O.O.
kapsule Spiriva 18 mikrograma,
not available
HR-H-342114823-01
prašak inhalata, tvrde
BOEHRINGER INGELHEIM
HR
ZAGREB D.O.O.
kapsule Spiriva 18 mikrograma,
not available
HR-H-342114823-03
prašak inhalata, tvrde
BOEHRINGER INGELHEIM
HR
ZAGREB D.O.O.
kapsule Spiriva 18 mikrograma,
not available
HR-H-342114823-04
prašak inhalata, tvrde
BOEHRINGER INGELHEIM
HR
ZAGREB D.O.O.
kapsule SPIRIVA 18 mikrogrami,
NL/H/0299/001
11-0234
inhalācijas pulveris cietās
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
kapsulās Spiriva Respimat 2,5
not available
HR-H-284647588
mikrograma po potisku,
BOEHRINGER INGELHEIM
HR
ZAGREB D.O.O.
otopina inhalata SRIVASSO 18 microgram,
NL/H/3137/001
PL 14598/0100
inhalation powder, hard
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
capsule Srivasso 18 Mikrogramm
NL/H/3137/001
Hartkapseln mit Pulver
136389
BOEHRINGER INGELHEIM
LI
INTERNATIONAL GMBH
zur Inhalation
List of nationally authorised medicinal products EMA/356882/2017
Page 16/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso® 18
NL/H/3137/001
136389
BOEHRINGER INGELHEIM
AT
Mikrogramm Hartkapseln
INTERNATIONAL GMBH
mit Pulver zur Inhalation Srivasso 18 mikrogramm
NL/H/3137/001
OGYI-T-22881/02
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában Srivasso 18 mikrogramm
NL/H/3137/001
OGYI-T-22881/01
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában SRIVASSO 18 microgram,
NL/H/3137/001
PA 775/8/1
inhalation powder, hard
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
capsule SRIVASSO 18 microgram,
NL/H/3137/001
MA 211/00601
inhalation powder, hard
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
capsule Srivasso,
NL/H/3137/001
54066
inhalationspulver, hårde
BOEHRINGER INGELHEIM
DK
INTERNATIONAL GMBH
kapsler Srivasso 18 míkrógrömm
NL/H/3137/001
IS/1/15/092/01
innöndunarduft, hart
BOEHRINGER INGELHEIM
IS
INTERNATIONAL GMBH
hylki Srivasso 18 Mikrogramm
NL/H/3137/001
92098.00.00
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
zur Inhalation SRIVASSO 18
NL/H/3137/001
MIKROGRAMŮ, prášek k
14/443/15-C
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
inhalaci v tvrdé tobolce
List of nationally authorised medicinal products EMA/356882/2017
Page 17/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso 18 mikrog
NL/H/3137/001
32218
BOEHRINGER INGELHEIM
FI
inhalaatiojauhe, kapseli,
INTERNATIONAL GMBH
kova Srivasso 18 mikrogram,
NL/H/3137/001
32218
inhalationspulver, hård
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
kapsel Сривасо 18 микрограма
NL/H/3137/001
20150298
прах за инхалация,
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
твърдa капсулa Srivasso 18 mikrogrami,
NL/H/3137/001
15-0194
inhalācijas pulveris cietā
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
kapsulā Srivasso 18 micrograme
NL/H/3137/001
8230/2015/07
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Srivasso 18 micrograme
NL/H/3137/001
8230/2015/06
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Srivasso 18 micrograme
NL/H/3137/001
8230/2015/05
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Srivasso 18 micrograme
NL/H/3137/001
8230/2015/04
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Srivasso 18 micrograme
NL/H/3137/001
capsule cu pulbere de
8230/2015/03
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat
List of nationally authorised medicinal products EMA/356882/2017
Page 18/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso 18 micrograme
NL/H/3137/001
8230/2015/02
BOEHRINGER INGELHEIM
RO
capsule cu pulbere de
INTERNATIONAL GMBH
inhalat Srivasso 18 micrograme
NL/H/3137/001
8230/2015/01
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Srivasso 18 microgrammi
NL/H/3137/001
043460070
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
043460068
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
043460056
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
043460043
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
043460031
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
043460029
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Srivasso 18 microgrammi
NL/H/3137/001
polvere per inalazione,
043460017
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida
List of nationally authorised medicinal products EMA/356882/2017
Page 19/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/003
BOEHRINGER INGELHEIM
LT
įkvepiamieji milteliai
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/002
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/001
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/007
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/006
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/005
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 mikrogramų
NL/H/3137/001
LT/1/15/3793/004
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Srivasso 18 microgram,
NL/H/3137/001
RVG 115252
inhalatiepoeder in harde
BOEHRINGER INGELHEIM
NL
INTERNATIONAL GMBH
capsules Srivasso® 18
NL/H/3137/001
Mikrogramm
BE477057
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Hartkapseln mit Pulver zur Inhalation
List of nationally authorised medicinal products EMA/356882/2017
Page 20/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso 18
NL/H/3137/001
BE477057
BOEHRINGER INGELHEIM
BE
microgrammes poudre
INTERNATIONAL GMBH
pour inhalation en gélules Srivasso 18 microgram
NL/H/3137/001
BE477057
inhalatiepoeder in harde
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
capsules Srivasso 18 microgram
NL/H/3137/001
14/10059
inhalation powder, hard
BOEHRINGER INGELHEIM
NO
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
H/15/02064/007
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
H/15/02064/006
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
H/15/02064/005
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
H/15/02064/004
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
H/15/02064/003
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
inhalation powder, hard
H/15/02064/002
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule
List of nationally authorised medicinal products EMA/356882/2017
Page 21/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Srivasso 18 microgram
NL/H/3137/001
H/15/02064/001
BOEHRINGER INGELHEIM
SI
inhalation powder, hard
INTERNATIONAL GMBH
capsule Srivasso 18 microgram
NL/H/3137/001
51052
inhalation powder, hard
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
capsule Srivasso 18 mikrogramov
NL/H/3137/001
14/0444/15-S
inhalačný prášok v tvrdej
BOEHRINGER INGELHEIM
SK
INTERNATIONAL GMBH
kapsule Srivasso, 18 µg, proszek
NL/H/3137/001
22882
do inhalacji w kapsułce
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
twardej Srivasso® 18
NL/H/3137/001
2016040086
Mikrogramm
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
Hartkapseln mit Pulver zur Inhalation Srivasso 18
NL/H/3137/001
2016040086
microgrammes poudre
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
pour inhalation en gélules Srivasso® 18
NL/H/3137/001
57292/18-7-2016
μικρογραμμάρια, κόνις για
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο Srivasso®18
NL/H/3137/001
022341
μικρογραμμάρια, κόνις για
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο SRIVASSO 18
NL/H/3137/001
microgrammes, poudre
34009 300 412 8 4
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule
List of nationally authorised medicinal products EMA/356882/2017
Page 22/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SRIVASSO 18
NL/H/3137/001
34009 300 412 9 1
BOEHRINGER INGELHEIM
FR
microgrammes, poudre
INTERNATIONAL GMBH
pour inhalation en gélule SRIVASSO 18
NL/H/3137/001
34009 300 413 0 7
microgrammes, poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule SRIVASSO 18
NL/H/3137/001
34009 550 152 3 9
microgrammes, poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule Braltus 10
UK/H/5648/001
14/314/16-C
mikrogramů/dávka
TEVA PHARMACEUTICALS
CZ
CR, S.R.O.
Prášek k inhalaci v tvrdé tobolce Braltus 10 Mikrogramm
UK/H/5648/001
137089
pro abgegebener Dosis
RATIOPHARM ARZNEIMITTEL
AT
VERTRIEBS-GMBH
Pulver zur Inhalation, Hartkapseln Braltus 10 mikrogrami
UK/H/5648/001
16-0144
TEVA B.V
LV
UK/H/5648/001
93505.00.00
TEVA GMBH
DE
UK/H/5648/001
RVG 116447
TEVA NEDERLAND B.V.
NL
saņemtajā devā, inhalācijas pulveris, cietās kapsulas Braltus® 10 Mikrogramm Hartkapseln mit Pulver zur Inhalation Tiotrus 10 microgram/dosis inhalatiepoeder in harde capsules
List of nationally authorised medicinal products EMA/356882/2017
Page 23/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Braltus 10
UK/H/5648/001
BE499404
TEVA PHARMA BELGIUM
BE
microgrammes/dose,
N.V./S.A
poudre pour inhalation en gélule Braltus 10 mikrogram/
UK/H/5648/001
52015
TEVA SWEDEN AB
SE
UK/H/5648/001
20160252
TEVA PHARMACEUTICALS
BG
dos inhalationspulver, hård kapsel Бралтус 10 микрограма на доставена доза прах
BULGARIA EOOD
за инхалация, твърда капсула Braltus 10 microgram per
UK/H/5648/001
PL 00289/1870
TEVA UK LIMITED
UK
UK/H/5648/001
HR-H-818206056
PLIVA HRVATSKA D.O.O.
HR
UK/H/5648/001
BE499404
TEVA PHARMA BELGIUM
BE
delivered dose inhalation powder, hard capsule Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule Braltus 10 microgram/dosis
N.V./S.A
inhalatiepoeder in harde capsule Braltus 10 Mikrogramm
UK/H/5648/001
BE499404
pro Dosis Hartkapsel mit
TEVA PHARMA BELGIUM
BE
N.V./S.A
Pulver zur Inhalation Braltus 10 mikrogramov
UK/H/5648/001
inhalačný prášok v tvrdej
14/0338/16-S
TEVA PHARMACEUTICALS
SK
SLOVAKIA S.R.O
kapsule
List of nationally authorised medicinal products EMA/356882/2017
Page 24/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Braltus,
UK/H/5648/001
54991
TEVA DENMARK A/S
DK
UK/H/5648/001
IS/1/16/063/01
TEVA B.V
IS
UK/H/5648/001
OGYI-T-23055/01
TEVA GYÓGYSZERGYÁR ZRT
HU
UK/H/5648/001
PA1986/006/001
TEVA B.V
IE
UK/H/5648/001
80981
TEVA PHARMA S.L.U
ES
UK/H/5648/001
14-10384
TEVA SWEDEN AB
NO
UK/H/5648/001
5687652
TEVA PHARMA – PRODUTOS
PT
inhalationspulver, hårde kapsler Braltus 10 míkróg í gefnum skammti, innöndunarduft, hart hylki Braltus 10 mikrogramm adagolt inhalációs por kemény kapszulában Braltus 10 microgram per delivered dose inhalation powder, hard capsule Braltus 10 microgramos/dosis liberada polvo para inhalación (cápsula dura) Braltus 10 mikrogram per levert dose inhalasjonspulver, hard kapsel Braltus, 10 microgramas por dose libertada, pó
FARMACÊUTICOS LDA
para inalação, cápsula Braltus, 10 microgramas
UK/H/5648/001
por dose libertada, pó
5687744
TEVA PHARMA – PRODUTOS
PT
FARMACÊUTICOS LDA
para inalação, cápsula
List of nationally authorised medicinal products EMA/356882/2017
Page 25/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Braltus 10
UK/H/5648/001
LT/1/16/3950/004
TEVA B.V
LT
UK/H/5648/001
LT/1/16/3950/001
TEVA B.V
LT
UK/H/5648/001
LT/1/16/3950/003
TEVA B.V
LT
UK/H/5648/001
MA1060/00301
TEVA B.V
MT
UK/H/5648/001
LT/1/16/3950/002
TEVA B.V
LT
UK/H/5648/001
9464/2016/02
TEVA PHARMACEUTICALS
RO
mikrogramų/dozėje įkvepiamieji milteliai (kietosios kapsulės) Braltus 10 mikrogramų/dozėje įkvepiamieji milteliai (kietosios kapsulės) Braltus 10 mikrogramų/dozėje įkvepiamieji milteliai (kietosios kapsulės) Braltus 10 microgram per delivered dose inhalation powder, hard capsule Braltus 10 mikrogramų/dozėje įkvepiamieji milteliai (kietosios kapsulės) Gregal 10 micrograme pulbere de inhalat
S.R.L
capsulă Braltus 10 mikrog
UK-H-5648-001
32814
TEVA B.V
FI
UK/H/5648/001
23520
TEVA PHARMACEUTICALS
PL
/vapautunut annos, inhalaatiojauhe, kapseli, kova Braltus, 10 mikrogramów/ dawkę
List of nationally authorised medicinal products EMA/356882/2017
POLSKA SP. Z O.O.
Page 26/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK-H-5648-001
32814
TEVA B.V
FI
UK/H/5648/001
9464/2016/04
TEVA PHARMACEUTICALS
RO
dostarczoną, proszek do inhalacji w kapsułce twardej Braltus 10 mikrog /vapautunut annos, inhalaatiojauhe, kapseli, kova Gregal 10 micrograme pulbere de inhalat
S.R.L
capsulă Braltus 10 mikrogramov
UK/H/5648/001
H/16/02225/001
TEVA B.V
SI
UK/H/5648/001
9464/2016/03
TEVA PHARMACEUTICALS
RO
na dostavljen odmerek, prašek za inhaliranje, trde kapsule Gregal 10 micrograme pulbere de inhalat
S.R.L
capsulă Braltus, 10 mikrogrammi
UK/H/5648/001
914616
TEVA B.V
EE
UK/H/5648/001
9464/2016/01
TEVA PHARMACEUTICALS
RO
annuses, inhalatsioonipulber kõvakapslis Gregal 10 micrograme pulbere de inhalat
S.R.L
capsulă Favynd 18 microgram
NL/H/3136/001
inhalation powder, hard
PL 14598/0099
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
capsule
List of nationally authorised medicinal products EMA/356882/2017
Page 27/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 Mikrogramm
NL/H/3136/001
136358
BOEHRINGER INGELHEIM
AT
Hartkapseln mit Pulver
INTERNATIONAL GMBH
zur Inhalation Favynd 18 Mikrogramm
NL/H/3136/001
136358
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
LI
INTERNATIONAL GMBH
zur Inhalation Favynd 18 Mikrogramm
NL/H/3136/001
92097.00.00
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
zur Inhalation FAVYND 18 microgram,
NL/H/3136/001
PA 775/7/1
inhalation powder, hard
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
capsule Favynd 18 mikrogramm
NL/H/3136/001
OGYI-T-22880/02
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában Favynd 18 mikrogramm
NL/H/3136/001
OGYI-T-22880/01
inhalációs por kemény
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
kapszulában Favynd 18 microgram,
NL/H/3136/001/DC
MA 211/00501
inhalation powder, hard
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
capsule Favynd,
NL/H/3136/001
54068
inhalationspulver, hårde
BOEHRINGER INGELHEIM
DK
INTERNATIONAL GMBH
kapsler Favynd 18 míkrógrömm
NL/H/3136/001
innöndunarduft, hart
IS/1/15/093/01
BOEHRINGER INGELHEIM
IS
INTERNATIONAL GMBH
hylki
List of nationally authorised medicinal products EMA/356882/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 mikrog
NL/H/3136/001
32216
BOEHRINGER INGELHEIM
FI
inhalaatiojauhe, kapseli,
INTERNATIONAL GMBH
kova Favynd 18 mikrogram,
NL/H/3136/001
32216
inhalationspulver, hård
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
kapsel FAVYND 18
NL/H/3136/001
14/442/15-C
MIKROGRAMŮ, prášek k
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
inhalaci v tvrdé tobolce Фавинд 18 микрограма
NL/H/3136/001
20150299
прах за инхалация,
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
твърдa капсулa Favynd 18 mikrogrami,
NL/H/3136/001
15-0193
inhalācijas pulveris cietā
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
kapsulā Favynd 18 micrograme
NL/H/3136/001
8231/2015/07
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Favynd 18 micrograme
NL/H/3136/001
8231/2015/06
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Favynd 18 micrograme
NL/H/3136/001
8231/2015/05
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Favynd 18 micrograme
NL/H/3136/001
capsule cu pulbere de
8231/2015/04
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat
List of nationally authorised medicinal products EMA/356882/2017
Page 29/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 micrograme
NL/H/3136/001
8231/2015/03
BOEHRINGER INGELHEIM
RO
capsule cu pulbere de
INTERNATIONAL GMBH
inhalat Favynd 18 micrograme
NL/H/3136/001
8231/2015/02
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Favynd 18 micrograme
NL/H/3136/001
8231/2015/01
capsule cu pulbere de
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
inhalat Favynd 18 microgrammi
NL/H/3136/001
043459078
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Favynd 18 microgrammi
NL/H/3136/001
043459066
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Favynd 18 microgrammi
NL/H/3136/001
043459054
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Favynd 18 microgrammi
NL/H/3136/001
043459041
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Favynd 18 microgrammi
NL/H/3136/001
043459039
polvere per inalazione,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida Favynd 18 microgrammi
NL/H/3136/001
polvere per inalazione,
043459027
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
capsula rigida
List of nationally authorised medicinal products EMA/356882/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 microgrammi
NL/H/3136/001
043459015
BOEHRINGER INGELHEIM
IT
polvere per inalazione,
INTERNATIONAL GMBH
capsula rigida Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/007
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/006
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/005
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/004
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/003
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/002
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 mikrogramų
NL/H/3136/001
LT/1/15/3789/001
įkvepiamieji milteliai
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
(kietosios kapsulės) Favynd 18 microgram,
NL/H/3136/001
inhalatiepoeder in harde
RVG 115251
BOEHRINGER INGELHEIM
NL
INTERNATIONAL GMBH
capsules
List of nationally authorised medicinal products EMA/356882/2017
Page 31/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 microgram
NL/H/3136/001
14/10058
BOEHRINGER INGELHEIM
NO
inhalation powder, hard
INTERNATIONAL GMBH
capsule Favynd® 18 Mikrogramm
NL/H/3136/001
BE477040
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
zur Inhalation Favynd 18 microgrammes
NL/H/3136/001
BE477040
poudre pour inhalation en
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
gélule Favynd 18 microgram
NL/H/3136/001
BE477040
inhalatiepoeder in harde
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
capsules Favynd 18 microgram
NL/H/3136/001
H/15/02063/007
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
H/15/02063/006
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
H/15/02063/005
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
H/15/02063/004
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
inhalation powder, hard
H/15/02063/003
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule
List of nationally authorised medicinal products EMA/356882/2017
Page 32/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd 18 microgram
NL/H/3136/001
H/15/02063/002
BOEHRINGER INGELHEIM
SI
inhalation powder, hard
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
H/15/02063/001
inhalation powder, hard
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
capsule Favynd 18 microgram
NL/H/3136/001
51051
inhalation powder, hard
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
capsule Favynd 18 mikrogramov
NL/H/3136/001
14/0443/15-S
inhalačný prášok v tvrdej
BOEHRINGER INGELHEIM
SK
INTERNATIONAL GMBH
kapsule Favynd, 18 µg, proszek
NL/H/3136/001
22897
do inhalacji w kapsułce
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
twardej Favynd 18 microgrammes
NL/H/3136/001
2016040044
poudre pour inhalation en
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
gélule Favynd® 18 Mikrogramm
NL/H/3136/001
2016040044
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
zur Inhalation Favynd® 18 Mikrogramm
NL/H/3136/001
2016040044
Hartkapseln mit Pulver
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
zur Inhalation Favynd 18 microgrammes
NL/H/3136/001
poudre pour inhalation en
2016040044
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
gélule
List of nationally authorised medicinal products EMA/356882/2017
Page 33/34
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Favynd® 18
NL/H/3136/001
57291/18-7-2016
BOEHRINGER INGELHEIM
GR
μικρογραμμάρια, κόνις για
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο Favynd®18
NL/H/3136/001
022342
μικρογραμμάρια, κόνις για
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
εισπνοή, σκληρό καψάκιο FAVYND 18
NL/H/3136/001
34009 550 152 2 2
microgrammes, poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule FAVYND 18
NL/H/3136/001
34009 300 412 6 0
microgrammes, poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule FAVYND 18
NL/H/3136/001
34009 300 412 5 3
microgrammes, poudre
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule FAVYND 18
NL/H/3136/001
microgrammes, poudre
34009 300 412 7 7
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
pour inhalation en gélule
List of nationally authorised medicinal products EMA/356882/2017
Page 34/34
