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