11 January 2018 EMA/27280/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: olodaterol / tiotropium
Procedure no.: PSUSA/00010489/201705
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Spiolto® Respimat® 2,5
NL/H/3157/001
136299
BOEHRINGER INGELHEIM
LI
Mikrogramm/2,5 Mikrogramm
INTERNATIONAL GMBH
Lösung zur Inhalation Spiolto Respimat 2,5
NL/H/3157/001
79967
microgramos/2,5 microgramos,
BOEHRINGER INGELHEIM
ES
INTERNATIONAL GMBH
solución para inhalación Spiolto Respimat 2,5
NL/H/3157/001
HR-H-852053792-04
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Spiolto Respimat 2,5
NL/H/3157/001
HR-H-852053792-03
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Spiolto Respimat 2,5
NL/H/3157/001
HR-H-852053792-02
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Spiolto Respimat 2,5
NL/H/3157/001
HR-H-852053792-01
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Spiolto Respimat 2,5
NL/H/3157/001
7868/2015/04
micrograme/2,5 micrograme
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat Spiolto Respimat 2,5
NL/H/3157/001
7868/2015/03
micrograme/2,5 micrograme
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat Spiolto Respimat 2,5
NL/H/3157/001
7868/2015/02
micrograme/2,5 micrograme
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat Spiolto Respimat 2,5
NL/H/3157/001
micrograme/2,5 micrograme
7868/2015/01
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat List of nationally authorised medicinal products EMA/27280/2018
Page 2/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Spiolto® Respimat® 2,5
NL/H/3157/001
136299
BOEHRINGER INGELHEIM
AT
Mikrogramm/2,5 Mikrogramm
INTERNATIONAL GMBH
Lösung zur Inhalation Spiolto Respimat 2,5
NL/H/3157/001
RVG 115528
microgram/2,5 microgram
BOEHRINGER INGELHEIM
NL
INTERNATIONAL GMBH
inhalatieoplossing Spiolto Respimat 2.5
NL/H/3157/001
PL 14598/0101
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
inhalation solution SPIOLTO RESPIMAT 2,5
NL/H/3157/001
14/362/15-C
MIKROGRAMŮ/ 2,5
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
MIKROGRAMŮ, roztok k inhalaci Spiolto Respimat 2,5
NL/H/3157/001
OGYI-T-22867/01
mikrogramm/2,5 mikrogramm,
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
inhalációs oldat Spiolto Respimat 2,5
NL/H/3157/001
15-0152
mikrogrami/2,5 mikrogrami
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
šķīdums inhalācijām Spiolto Respimat,
NL/H/3157/001
54282
NL/H/3157/001
14/0203/15-S
inhalationsvæske, opløsning Spiolto Respimat 2,5
BOEHRINGER INGELHEIM
DK
INTERNATIONAL GMBH
mikrogramu/2,5 mikrogramu
BOEHRINGER INGELHEIM
SK
INTERNATIONAL GMBH
inhalacny roztok Spiolto Respimat 2,5 míkróg/2,5
NL/H/3157/001
IS/1/15/044/01
míkróg innöndunarlausn Spiolto Respimat 2,5
BOEHRINGER INGELHEIM
IS
INTERNATIONAL GMBH NL/H/3157/001
Mikrogramm/2,5
BE475093
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Mikrogramm/Inhalation, Lösung zur Inhalation
List of nationally authorised medicinal products EMA/27280/2018
Page 3/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Spiolto Respimat 2,5
NL/H/3157/001
BE475093
BOEHRINGER INGELHEIM
BE
microgrammes/2,5
INTERNATIONAL GMBH
microgrammes/inhalation, solution à inhaler Spiolto Respimat 2,5
NL/H/3157/001
BE475093
microgram/2,5
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
microgram/inhalatie, inhalatieoplossing Spiolto Respimat 2,5
NL/H/3157/001
14-10100
mikrogram/2,5 mikrogram
BOEHRINGER INGELHEIM
NO
INTERNATIONAL GMBH
inhalasjonsvæske, oppløsning Spiolto Respimat 2,5
NL/H/3157/001
H/15/02083/004
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Spiolto Respimat 2,5
NL/H/3157/001
H/15/02083/003
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Spiolto Respimat 2,5
NL/H/3157/001
H/15/02083/002
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Spiolto Respimat 2,5
NL/H/3157/001
mikrogramov/2,5
H/15/02083/001
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje
List of nationally authorised medicinal products EMA/27280/2018
Page 4/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Spiolto Respimat 2,5
NL/H/3157/001
2015120248
BOEHRINGER INGELHEIM
LU
Mikrogramm/2,5
INTERNATIONAL GMBH
Mikrogramm/Inhalation, Lösung zur Inhalation Spiolto Respimat 2,5
NL/H/3157/001
2015120248
microgrammes/2,5
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
microgrammes/inhalation, solution à inhaler Spiolto® Respimat® 2,5
NL/H/3157/001
92213.00.00
Mikrogramm/2,5 Mikrogramm
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
pro Hub Lösung zur Inhalation Spiolto Respimat 2.5
NL/H/3157/001
PA 775/9/1
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
inhalation solution Spiolto Respimat 2.5
NL/H/3157/001
MA 211/00701
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
inhalation solution Spiolto Respimat 2,5
NL/H/3157/001
LT/1/15/3759/004
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Spiolto Respimat 2,5
NL/H/3157/001
LT/1/15/3759/003
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Spiolto Respimat 2,5
NL/H/3157/001
mikrogramo/2,5
LT/1/15/3759/002
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas
List of nationally authorised medicinal products EMA/27280/2018
Page 5/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Spiolto Respimat 2,5
NL/H/3157/001
LT/1/15/3759/001
BOEHRINGER INGELHEIM
LT
mikrogramo/2,5
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Spiolto Respimat 2,5
NL/H/3157/001
043661040
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Spiolto Respimat 2,5
NL/H/3157/001
043661038
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Spiolto Respimat 2,5
NL/H/3157/001
043661026
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Spiolto Respimat 2,5
NL/H/3157/001
043661014
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Spiolto Respimat 2,5
NL/H/3157/001
877615
mikrogrammi/2,5 mikrogrammi,
BOEHRINGER INGELHEIM
EE
INTERNATIONAL GMBH
inhalatsioonilahus Spiolto Respimat 2,5
NL/H/3157/001
51247
mikrogram/2,5 mikrogram
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
inhalationsvätska, lösning SPIOLTO RESPIMAT 2,5
NL/H/3157/001
microgrammes/2,5
34009 550 152 7 7
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/dose, solution à inhaler
List of nationally authorised medicinal products EMA/27280/2018
Page 6/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
SPIOLTO RESPIMAT 2,5
NL/H/3157/001
34009 550 152 9 1
BOEHRINGER INGELHEIM
FR
microgrammes/2,5
INTERNATIONAL GMBH
microgrammes/dose, solution à inhaler SPIOLTO RESPIMAT 2,5
NL/H/3157/001
34009 550 153 0 7
microgrammes/2,5
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/dose, solution à inhaler SPIOLTO RESPIMAT 2,5
NL/H/3157/001
34009 300 413 2 1
microgrammes/2,5
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/dose, solution à inhaler Spiolto Respimat 2,5
NL/H/3157/001
46027/14/7-6-2016
μικρογραμμάρια/2,5
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
μικρογραμμάρια, εισπνεόμενο διάλυμα Spiolto Respimat 2,5
NL/H/3157/001
22941
mikrograma + 2,5 mikrograma
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
roztwór do inhalacji Спиолто Респимат 2,5
NL/H/3157/001
20150259
микрограма/2,5 микрограма
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
разтвор за инхалация Spiolto Respimat 2,5
NL/H/3157/001
5653019
microgramas/2,5 microgramas,
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
solução para inalação Spiolto Respimat 2,5
NL/H/3157/001
microgramas/2,5 microgramas,
5653027
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
solução para inalação
List of nationally authorised medicinal products EMA/27280/2018
Page 7/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Inspiolto Respimat 2,5
NL/H/3157/001
34150
BOEHRINGER INGELHEIM
FI
mikrog/2,5 mikrog,
INTERNATIONAL GMBH
inhalaationeste, liuos Inspiolto Respimat 2,5
NL/H/3157/001
34150
mikrogram/2,5 mikrogram
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
inhalationsvätska, lösning Spiolto Respimat 2,5
NL/H/3157/001
022379
μικρογραμμάρια/2,5
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
μικρογραμμάρια, εισπνεόμενο διάλυμα Spiolto Respimat 2,5
NL/H/3157/001
2015120248
Mikrogramm/2,5
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
Mikrogramm/Inhalation, Lösung zur Inhalation Spiolto Respimat 2,5
NL/H/3157/001
2015120248
microgrammes/2,5
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
microgrammes/inhalation, solution à inhaler Yanimo Respimat 2,5
NL/H/3158/001
7867/2015/04
micrograme/2,5 micrograme
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat Yanimo Respimat 2,5
NL/H/3158/001
7867/2015/03
micrograme/2,5 micrograme
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat Yanimo Respimat 2,5
NL/H/3158/001
micrograme/2,5 micrograme
7867/2015/02
BOEHRINGER INGELHEIM
RO
INTERNATIONAL GMBH
soluţie pentru inhalat
List of nationally authorised medicinal products EMA/27280/2018
Page 8/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Yanimo Respimat 2,5
NL/H/3158/001
7867/2015/01
BOEHRINGER INGELHEIM
RO
micrograme/2,5 micrograme
INTERNATIONAL GMBH
soluţie pentru inhalat Yanimo Respimat 2,5
NL/H/3158/001
79966
microgramos/2,5 microgramos,
BOEHRINGER INGELHEIM
ES
INTERNATIONAL GMBH
solución para inhalación Yanimo Respimat 2,5
NL/H/3158/001
HR-H-555411623-04
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Yanimo Respimat 2,5
NL/H/3158/001
HR-H-555411623-03
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Yanimo Respimat 2,5
NL/H/3158/001
HR-H-555411623-02
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Yanimo Respimat 2,5
NL/H/3158/001
HR-H-555411623-01
mikrograma/2,5 mikrograma,
BOEHRINGER INGELHEIM
HR
INTERNATIONAL GMBH
otopina inhalata Yanimo Respimat 2,5
NL/H/3158/001
OGYI-T-22868/01
mikrogramm/2,5 mikrogramm,
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH
inhalációs oldat Yanimo Respimat 2,5
NL/H/3158/001
15-0151
mikrogrami/2,5 mikrogrami
BOEHRINGER INGELHEIM
LV
INTERNATIONAL GMBH
šķīdums inhalācijām Yanimo Respimat,
NL/H/3158/001
54283
inhalationsvæske, opløsning Yanimo Respimat 2,5
BOEHRINGER INGELHEIM
DK
INTERNATIONAL GMBH NL/H/3158/001
mikrogrammi/2,5 mikrogrammi,
877915
BOEHRINGER INGELHEIM
EE
INTERNATIONAL GMBH
inhalatsioonilahus
List of nationally authorised medicinal products EMA/27280/2018
Page 9/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Yanimo Respimat 2,5 míkróg/2,5
NL/H/3158/001
IS/1/15/067/01
BOEHRINGER INGELHEIM
IS
míkróg, innöndunarlausn YANIMO RESPIMAT 2,5
INTERNATIONAL GMBH NL/H/3158/001
14/363/15-C
MIKROGRAMŮ/ 2,5
BOEHRINGER INGELHEIM
CZ
INTERNATIONAL GMBH
MIKROGRAMŮ, roztok k inhalaci Yanimo Respimat 2.5
NL/H/3158/001
PA 775/10/1
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
IE
INTERNATIONAL GMBH
inhalation solution Yanimo Respimat 2.5
NL/H/3158/001
PL 14598/0102
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
inhalation solution Yanimo Respimat 2,5
NL/H/3158/001
043660048
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Yanimo Respimat 2,5
NL/H/3158/001
043660036
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Yanimo Respimat 2,5
NL/H/3158/001
043660024
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Yanimo Respimat 2,5
NL/H/3158/001
043660012
microgrammi/2,5 microgrammi,
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
soluzione per inalazione Yanimo Respimat 2.5
NL/H/3158/001
MA211/00801
microgram/2.5 microgram,
BOEHRINGER INGELHEIM
MT
INTERNATIONAL GMBH
inhalation solution Yanimo Respimat 2,5
NL/H/3158/001
mikrogram/2,5 mikrogram
51248
BOEHRINGER INGELHEIM
SE
INTERNATIONAL GMBH
inhalationsvätska, lösning
List of nationally authorised medicinal products EMA/27280/2018
Page 10/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Yanimo Respimat 2,5
NL/H/3158/001
14-10101
BOEHRINGER INGELHEIM
NO
mikrogram/2,5 mikrogram
INTERNATIONAL GMBH
inhalasjonsvæske, oppløsning Yanimo Respimat 2,5
NL/H/3158/001
LT/1/15/3755/004
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Yanimo Respimat 2,5
NL/H/3158/001
LT/1/15/3755/003
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Yanimo Respimat 2,5
NL/H/3158/001
LT/1/15/3755/002
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Yanimo Respimat 2,5
NL/H/3158/001
LT/1/15/3755/001
mikrogramo/2,5
BOEHRINGER INGELHEIM
LT
INTERNATIONAL GMBH
mikrogramo/išpurškime įkvepiamasis tirpalas Yanimo® Respimat® 2,5
NL/H/3158/001
92214.00.00
Mikrogramm/2,5 Mikrogramm
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
pro Hub Lösung zur Inhalation Yanimo Respimat 2,5
NL/H/3158/001
RVG 115529
microgram/2,5 microgram,
BOEHRINGER INGELHEIM
NL
INTERNATIONAL GMBH
inhalatieoplossing Yanimo Respimat 2,5
NL/H/3158/001
mikrogramu/2,5 mikrogramu
14/0204/15-S
BOEHRINGER INGELHEIM
SK
INTERNATIONAL GMBH
inhalačný roztok
List of nationally authorised medicinal products EMA/27280/2018
Page 11/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
YANIMO RESPIMAT 2,5
NL/H/3158/001
34009 550 152 6 0
BOEHRINGER INGELHEIM
FR
microgrammes/ 2,5
INTERNATIONAL GMBH
microgrammes/ dose, solution à inhaler YANIMO RESPIMAT 2,5
NL/H/3158/001
34009 550 152 5 3
microgrammes/ 2,5
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/ dose, solution à inhaler YANIMO RESPIMAT 2,5
NL/H/3158/001
34009 550 152 4 6
microgrammes/ 2,5
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/ dose, solution à inhaler YANIMO RESPIMAT 2,5
NL/H/3158/001
34009 300 413 1 4
microgrammes/ 2,5
BOEHRINGER INGELHEIM
FR
INTERNATIONAL GMBH
microgrammes/ dose, solution à inhaler Янимо Респимат 2,5
NL/H/3158/001
20150258
микрограма/2,5 микрограма
BOEHRINGER INGELHEIM
BG
INTERNATIONAL GMBH
разтвор за инхалация Yanimo Respimat 2,5
NL/H/3158/001
5653035
microgramas/2,5 microgramas,
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
solução para inalação Yanimo Respimat 2,5
NL/H/3158/001
5653043
microgramas/2,5 microgramas,
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
solução para inalação Yanimo Respimat 2,5
NL/H/3158/001
Mikrogramm/2,5 Mikrogramm –
136282
BOEHRINGER INGELHEIM
AT
INTERNATIONAL GMBH
Inhalationslösung
List of nationally authorised medicinal products EMA/27280/2018
Page 12/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Yanimo Respimat 2,5
NL/H/3158/001
BE475102
BOEHRINGER INGELHEIM
BE
Mikrogramm/2,5
INTERNATIONAL GMBH
Mikrogramm/Inhalation, Lösung zur Inhalation Yanimo Respimat 2,5
NL/H/3158/001
BE475102
microgrammes/2,5
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
microgrammes/inhalation, solution à inhaler Yanimo Respimat 2,5
NL/H/3158/001
BE475102
microgram/2,5
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
microgram/inhalatie, inhalatieoplossing Yanimo Respimat 2,5
NL/H/3158/001
136282
Mikrogramm/2,5 Mikrogramm –
BOEHRINGER INGELHEIM
LI
INTERNATIONAL GMBH
Inhalationslösung Yanimo Respimat, 2,5
NL/H/3158/001
22942
mikrograma + 2,5 mikrograma,
BOEHRINGER INGELHEIM
PL
INTERNATIONAL GMBH
roztwór do inhalacji Yanimo Respimat 2,5 mikrog/2,5
NL/H/3158/001
34151
mikrog inhalaationeste, liuos Yanimo Respimat 2,5
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH NL/H/3158/001
34151
mikrogram/2,5 mikrogram
BOEHRINGER INGELHEIM
FI
INTERNATIONAL GMBH
inhalationsvätska, lösning Yanimo Respimat 2,5
NL/H/3158/001
μικρογραμμάρια/2,5
65663/05-09-2016
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
μικρογραμμάρια, εισπνεόμενο διάλυμα
List of nationally authorised medicinal products EMA/27280/2018
Page 13/14
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Yanimo Respimat 2,5
NL/H/3158/001
2016040103
BOEHRINGER INGELHEIM
LU
Mikrogramm/2,5
INTERNATIONAL GMBH
Mikrogramm/Inhalation, Lösung zur Inhalation Yanimo Respimat 2,5
NL/H/3158/001
2016040103
microgrammes/2,5
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
microgrammes/inhalation, solution à inhaler Yanimo Respimat 2,5
NL/H/3158/001
H/16/02227/001
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Yanimo Respimat 2,5
NL/H/3158/001
H/16/02227/002
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Yanimo Respimat 2,5
NL/H/3158/001
H/16/02227/003
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Yanimo Respimat 2,5
NL/H/3158/001
H/16/02227/004
mikrogramov/2,5
BOEHRINGER INGELHEIM
SI
INTERNATIONAL GMBH
mikrogramov/vdih raztopina za inhaliranje Yanimo Respimat 2,5
NL/H/3158/001
μικρογραμμάρια/2,5
022387
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
μικρογραμμάρια, εισπνεόμενο διάλυμα
List of nationally authorised medicinal products EMA/27280/2018
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