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

List of nationally authorised medicinal products EMA/356882/2017 /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


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


BE



SI



SI



SI

Spiriva® Respimat 2,5 μικρογραμμάρια, διάλυμα για εισπνοή


GR

Spiriva® Respimat 2,5 μικρογραμμάρια, διάλυμα για εισπνοή

NL/H/0718/001 61514/12 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

GR






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


CY

Spiriva Respimat, 2,5 mikrogrammi, inhalatsioonilahus


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


AT

SPIRIVA RESPIMAT 2,5 mikrogramu, roztok k inhalaci

NL/H/0718/001 14/666/07-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH

CZ






Spiriva Respimat 2,5 microgrammi, soluzione per inalazione


IT



IT



IT



IT

Spiriva Respimat 2,5 mikrog, inhalaationeste, liuos


FI

Spiriva Respimat 2,5 mikrogramo/išpurškime įkvepiamasis tirpalas

NL/H/0718/001 LT/1/07/0923/001 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

LT



LT



LT



LT






Spiriva 2,5 mikrogram inhalasjonsvæske, oppløsning


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


LU

Spiriva Respimat 2,5 Mikrogramm, Lösung zur Inhalation


LU

Spiriva Respimat 2,5 mikrogrami šķīdums inhalācijām


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


PT

Spiriva Respimat, 2,5 mikrograma/dawke odmierzona, roztwór do inhalacji


PL






Spiriva Respimat, inhalationsvæske, opløsning


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



PT



PT

Spiriva Respimat 2,5 mikrogram, inhalationsvätska, lösning


SE



PT






Spiriva Respimat 2,5 micrograme solutie de inhalat

NL/H/0718/001 5642/2013/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

RO



RO



RO



RO

SPIRIVA RESPIMAT 2,5 microgrammes, solution à inhaler


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



FR



FR








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


FI

SPIRIVA 18 Mikrogramm Hartkapsel mit Pulver zur Inhalation


BE

SPIRIVA 18 Mikrogramm Hartkapsel mit Pulver zur Inhalation


LU

Spiriva 18 micrograme capsule cu pulbere de inhalat


RO






Spiriva 18 microgramas, pó para inalação, cápsula


PT



PT



PT



PT

Spiriva 18 mikrogramov prašek za inhaliranje, trde kapsule


SI

SPIRIVA® 18 microgram, inhalation powder, hard capsule


UK

SPIRIVA® 18 microgram, inhalation powder, hard capsule


IE

СПИРИВА 18 микрограма, прах за инхалация, твърдa капсулa


BG



PT






SPIRIVA 18 mikrog inhalaatiojauhe, kapseli, kova


FI



PT



PT

SPIRIVA 18 microgrammes poudre pour inhalation en gélule

NL/H/0299/001 566 813.9 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

FR



FR



FR


NL/H/0299/001 384 622.3 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

FR

Spiriva 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės)


LT



LT








LT



LT



LT



LT



LT

Spiriva 18 mikrogram inhalasjonspulver, hard kapsel


NO

SPIRIVA, 18 mikrogrammi inhalatsioonipulber kõvakapslis


EE

SPIRIVA 18 μικρογραμμάρια, κόνις για εισπνοή, σκληρό καψάκιο


GR

SPIRIVA®, 18 μικρογραμμάρια, κόνις για εισπνοή, σκληρό καψάκιο


CY






Spiriva 18 mikrogramov inhalačný prášok v tvrdej kapsule


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


CZ



SI



SI



SI



SI



SI



SI






SPIRIVA 18 microgramos polvo para inhalación

NL/H/0299/001 64.796 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

ES

Spiriva, inhalationspulver, hård kapsel


DK

Spiriva 18 míkrógrömm, innöndunarduft, hart hylki


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


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


HU

Spiriva® 18 Mikrogramm - Kapseln mit Inhalationspulver


AT

SPIRIVA® 18 Mikrogramm Kapsel mit Inhalationspulver


DE






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


RO

Spiriva 18 micrograme capsule cu pulbere de inhalat.


RO



RO



RO



RO



RO



RO

SPIRIVA 18 mikrogram, inhalationspulver, hård kapsel


SE








LU



BE

SPIRIVA 18 MICROGRAM INHALATIEPOEDER IN HARDE CAPSULE


BE

Spiriva 18 microgrammi, polvere per inalazione, capsula rigida


IT



IT



IT



IT



IT



IT








IT

Spiriva 18 mikrograma, prašak inhalata, tvrde kapsule

not available HR-H-342114823-02 BOEHRINGER INGELHEIM ZAGREB D.O.O.

HR



HR



HR



HR

SPIRIVA 18 mikrogrami, inhalācijas pulveris cietās kapsulās


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


UK

Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation


LI






Srivasso® 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation


AT

Srivasso 18 mikrogramm inhalációs por kemény kapszulában


HU

Srivasso 18 mikrogramm inhalációs por kemény kapszulában


HU



IE


NL/H/3137/001 MA 211/00601 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

MT

Srivasso, inhalationspulver, hårde kapsler


DK

Srivasso 18 míkrógrömm innöndunarduft, hart hylki


IS

Srivasso 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation


DE

SRIVASSO 18 MIKROGRAMŮ, prášek k inhalaci v tvrdé tobolce


CZ






Srivasso 18 mikrog inhalaatiojauhe, kapseli, kova


FI

Srivasso 18 mikrogram, inhalationspulver, hård kapsel


FI

Сривасо 18 микрограма прах за инхалация, твърдa капсулa


BG

Srivasso 18 mikrogrami, inhalācijas pulveris cietā kapsulā


LV

Srivasso 18 micrograme capsule cu pulbere de inhalat


RO



RO



RO



RO



RO








RO



RO

Srivasso 18 microgrammi polvere per inalazione, capsula rigida


IT



IT



IT



IT



IT



IT



IT






Srivasso 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės)


LT



LT



LT



LT



LT



LT



LT

Srivasso 18 microgram, inhalatiepoeder in harde capsules


NL


NL/H/3137/001 BE477057 BOEHRINGER INGELHEIM INTERNATIONAL GMBH

BE






Srivasso 18 microgrammes poudre pour inhalation en gélules


BE

Srivasso 18 microgram inhalatiepoeder in harde capsules


BE

Srivasso 18 microgram inhalation powder, hard capsule


NO



SI



SI



SI



SI



SI



SI








SI



SE

Srivasso 18 mikrogramov inhalačný prášok v tvrdej kapsule


SK

Srivasso, 18 µg, proszek do inhalacji w kapsułce twardej


PL



LU

Srivasso 18 microgrammes poudre pour inhalation en gélules


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


CY

SRIVASSO 18 microgrammes, poudre pour inhalation en gélule


FR








FR



FR



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






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


BE

Braltus 10 Mikrogramm pro Dosis Hartkapsel mit Pulver zur Inhalation


BE

Braltus 10 mikrogramov inhalačný prášok v tvrdej kapsule

UK/H/5648/001 14/0338/16-S TEVA PHARMACEUTICALS SLOVAKIA S.R.O

SK






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


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






Braltus 10 mikrogramų/dozėje įkvepiamieji milteliai (kietosios kapsulės)

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

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






dostarczoną, proszek do inhalacji w kapsułce twardej Braltus 10 mikrog /vapautunut annos, inhalaatiojauhe, kapseli, kova

UK-H-5648-001 32814 TEVA B.V FI



RO

Braltus 10 mikrogramov na dostavljen odmerek, prašek za inhaliranje, trde kapsule

UK/H/5648/001 H/16/02225/001 TEVA B.V SI



RO

Braltus, 10 mikrogrammi annuses, inhalatsioonipulber kõvakapslis

UK/H/5648/001 914616 TEVA B.V EE



RO

Favynd 18 microgram inhalation powder, hard capsule


UK






Favynd 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation


AT



LI



DE

FAVYND 18 microgram, inhalation powder, hard capsule


IE

Favynd 18 mikrogramm inhalációs por kemény kapszulában


HU

Favynd 18 mikrogramm inhalációs por kemény kapszulában


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


DK

Favynd 18 míkrógrömm innöndunarduft, hart hylki


IS






Favynd 18 mikrog inhalaatiojauhe, kapseli, kova


FI

Favynd 18 mikrogram, inhalationspulver, hård kapsel


FI

FAVYND 18 MIKROGRAMŮ, prášek k inhalaci v tvrdé tobolce


CZ

Фавинд 18 микрограма прах за инхалация, твърдa капсулa


BG

Favynd 18 mikrogrami, inhalācijas pulveris cietā kapsulā


LV

Favynd 18 micrograme capsule cu pulbere de inhalat


RO



RO



RO



RO








RO



RO



RO

Favynd 18 microgrammi polvere per inalazione, capsula rigida


IT



IT



IT



IT



IT



IT








IT

Favynd 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės)


LT



LT



LT



LT



LT



LT



LT

Favynd 18 microgram, inhalatiepoeder in harde capsules


NL








NO

Favynd® 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation


BE

Favynd 18 microgrammes poudre pour inhalation en gélule


BE

Favynd 18 microgram inhalatiepoeder in harde capsules


BE



SI



SI



SI



SI



SI








SI



SI



SE

Favynd 18 mikrogramov inhalačný prášok v tvrdej kapsule


SK

Favynd, 18 µg, proszek do inhalacji w kapsułce twardej


PL



LU



LU



LU



LU






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


CY

FAVYND 18 microgrammes, poudre pour inhalation en gélule


FR



FR



FR



FR

list of nationally authorised medicinal products · uk/h/5875/001 . 5687660 . ratiopharm-comercio e...

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