List of nationally authorised medicinal products

Transcription

1 28 September EMA/662335/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): levosalbutamol, salbutamol Procedure No.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction provided the source is acknowledged.

2 AIROMIR AUTOHALER 100 microgrammes/dose, not available NL20590 TEVA SANTÉ FR suspension pour inhalation en flacon pressurisé Buventol Easyhaler, inhalationspulver not available ORION CORPORATION DK Buventol Easyhaler, inhalationspulver not available ORION CORPORATION DK BUVENTOL EASYHALER, 200 not available ORION CORPORATION EE mikrogrammi/annuses inhaleeritav pulber BUVENTOL EASYHALER, 100 not available ORION CORPORATION EE mikrogrammi/annuses inhaleeritav pulber Buventol Easyhaler 200 mikrog/dos not available ORION OYJ FI inhalationspulver Buventol Easyhaler 100 mikrog/dos not available ORION OYJ FI inhalationspulver Buventol Easyhaler 100 mikrog/annos not available ORION OYJ FI inhalaatiojauhe Buventol Easyhaler 200 mikrog/annos not available ORION OYJ FI inhalaatiojauhe Salbutamol Orion Easyhaler 0,2 mg/dosis, Pulver not available ORION CORPORATION DE zur Inhalation Salbutamol Orion Easyhaler 0,1 mg/dosis, Pulver not available ORION CORPORATION DE zur Inhalation Novolizer Salbutamol 100 Mikrogramm / Dosis DE/H/0333/ S.A. MEDA PHARMA N.V. Pulver zur Inhalation Novolizer Salbutamol 100 Mikrogramm / Dosis DE/H/0333/ / S.A. MEDA PHARMA N.V. Pulver zur Inhalation Ventilastin Novolizer 100 microgramos / dosis DE/H/0333/ MEDA PHARMA S.L. ES polvo para inhalación Ventilastin Novolizer 100 Mikrogramm/Dosis DE/H/0333/ MEDA PHARMA GMBH & CO. KG DE Pulver zur Inhalation VENTILASTIN NOVOLIZER 100 DE/H/0333/ MEDA PHARMA SAS FR microgrammes/dose, poudre pour inhalation VENTILASTIN NOVOLIZER 100 DE/H/333/ MEDA PHARMA SAS FR microgrammes/dose, poudre pour inhalation VENTILASTIN NOVOLIZER 100 microgrammes/dose, poudre pour inhalation DE/H/333/ MEDA PHARMA SAS FR EMA/662335/2017 Page 2/19

3 VENTILASTIN NOVOLIZER 100 DE/H/333/ MEDA PHARMA SAS FR microgrammes/dose, poudre pour inhalation Novolizer Salbutamol Meda 100 DE/H/0333/ MEDA PHARMA GMBH AT Mikrogramm/Dosis Pulver zur Inhalation Novolizer Salbutamol 100 micrograms / dose DE/H/0333/001 PA1332/13/1 MEDA HEALTH SALES IRELAND IE inhalation powder LIMITED Novolizer Salbutamol 100 microgrammes/dose, DE/H/0333/ / S.A. MEDA PHARMA N.V. poudre pour inhalation. Salbutamol Novolizer 100 microgramas/dose, pó DE/H/0333/ MEDA PHARMA PRODUTOS para inalação FARMACÊUTICOS, S.A. Salbutamol Novolizer 100 microgramas/dose, pó DE/H/0333/ MEDA PHARMA PRODUTOS para inalação FARMACÊUTICOS, S.A. Salbutamol Novolizer 100 microgramas/dose, pó DE/H/0333/ MEDA PHARMA PRODUTOS para inalação FARMACÊUTICOS, S.A. Novolizer Salbutamol 100 microgrammes/dose, DE/H/0333/ S.A. MEDA PHARMA N.V. poudre pour inhalation Novolizer Salbutamol 100 microgram/dosis, DE/H/0333/ S.A. MEDA PHARMA N.V. inhalatiepoeder Salbutamol Novolizer 100 microgram, DE/H/0333/001 RVG MEDA PHARMA B.V. NL inhalatiepoeder SALBUTAMOL TEVA 100 microgrammes/dose, not available NL20587 TEVA SANTÉ FR suspension pour inhalation en flacon pressurisé Salbutamol Novolizer 100 Mikrogramm/Dosis DE/H/0865/ MEDA PHARMA GMBH & CO. KG DE Pulver zur Inhalation Ventilastin Novolizer 100 mikrogram/dos DE/H/0865/ MEDA OY FI inhalationspulver Ventilastin Novolizer 100 mikrog/annos DE/H/0865/ MEDA OY FI inhalaatiojauhe Ventilastin Novolizer 100 mikrogram/dos, DE/H/0865/ MEDA AB SE inhalationspulver Ventilastin Novolizer DE/H/0865/ MEDA AS DK Salamol CFC-Free Inhaler 100 micrograms UK/H/0449/001/MR PL 00530/0555 NORTON HEALTHCARE LTD T/A UK Pressurised Inhalation, suspension. IVAX PHARMACEUTICALS UK Ecosal Inhaler not available 14/439/00-C TEVA CZECH INDUSTRIES S.R.O CZ EMA/662335/2017 Page 3/19

4 Airsalb 0,1 mg/dose inhalasjonsaerosol, SE/H/0601/ SANDOZ A/S NO suspensjon Salbutamol Sandoz 100 micrograme/doza, SE/H/0971/ /2012/01 S.C. SANDOZ S.R.L. RO suspensie de inhalat presurizata Salbutamol Sandoz 100 micrograme/doza, SE/H/0971/ /2012/02 S.C. SANDOZ S.R.L. RO suspensie de inhalat presurizata Salbutamol Sandoz 100 micrograme/doza, SE/H/0971/ /2012/03 S.C. SANDOZ S.R.L. RO suspensie de inhalat presurizata Sabumalin, 100 mikrogramów/dawkę, aerozol SE/H/0601/ SANDOZ GMBH PL inhalacyjny, zawiesina Salbutamol Sandoz 100 Mikrogramm/Dosis - SE/H/0602/ SANDOZ GMBH AT Druckgasinhalation SALBUTAMOL SANDOZ 100 AEROSOL CFK-VRIJ, SE/H/0971/001 RVG 27018=26833 SANDOZ B.V. NL AEROSOL, SUSPENSIE, 100 MICOGRAM PER DOSIS Salbutamol Sandoz oplossing, inhalatievloeistof SE/H/0971/001 RVG 18093=57416 SANDOZ B.V. NL 5 mg/ml Salbutamol Sandoz 100 mikrogrami/devā SE/H/0601/ SANDOZ PHARMACEUTICALS LV aerosols inhalācijām zem spiediena, suspensija D.D. Airsalb, inhalationsspray, suspension SE/H/0601/ SANDOZ A/S DK Salbutamol Sandoz 100 mikrogram/dos SE/H/0971/ SANDOZ A/S SE inhalationsspray, suspension Airsalb 0,1mg/dos inhalationsspray, suspension SE/H/0603/ SANDOZ A/S SE Salbutamol Sandoz 100 mikrogrammaa/annos SE/H/0601/ SANDOZ A/S FI inhalaatiosumute, suspensio Salbutamol Sandoz 100 mikrogramų/dozėje SE/H/0601/001 LT/1/09/1654/002 SANDOZ PHARMACEUTICALS LT suslėgtoji įkvepiamoji suspensija D.D. Salbutamol Sandoz 100 mikrogramų/dozėje SE/H/0601/001 LT/1/09/1654/003 SANDOZ PHARMACEUTICALS LT suslėgtoji įkvepiamoji suspensija D.D. Salbutamol Sandoz 100 mikrogramų/dozėje SE/H/0601/001 LT/1/09/1654/001 SANDOZ PHARMACEUTICALS LT suslėgtoji įkvepiamoji suspensija D.D. Salbutamolo Sandoz 100 microgrammi/dose SE/H/0601/ SANDOZ S.P.A. IT sospensione pressurizzata per inalazione Salbutamolo Sandoz 100 microgrammi/dose SE/H/0601/ /M SANDOZ S.P.A. IT EMA/662335/2017 Page 4/19

5 sospensione pressurizzata per inalazione Salbutamolo Sandoz 100 microgrammi/dose SE/H/0601/ /M SANDOZ S.P.A. IT sospensione pressurizzata per inalazione Salbutamol Sandoz 100 microgramos/dosis, SE/H/0601/ SANDOZ FARMACÉUTICA, S.A. ES suspensión para inhalación en envase a presión Salbutamol Sandoz 100 mikrogramm/adag SE/H/0601/001 OGYI-T-21103/01 SANDOZ HUNGÁRIA KFT HU túlnyomásos inhalációs szuszpenzió Salbutamol Sandoz 100µg aërosol, suspensie SE/H/0601/ SANDOZ N.V. AirSalb CFC-free inhaler 100 microgram / dose SE/H/0601/001 PL 04416/0785 SANDOZ LTD UK Ventolin Syrup, 2 mg/5 ml siirup not available GLAXO WELLCOME LTD EE Ventolin roztok k inhalaci not available 14/219/72-C GLAXO GROUP LIMITED CZ Ventoline 0,1 mg/dose inhalasjonsaerosol, not available 5584 GLAXOSMITHKLINE AS NO suspensjon Ventolin Diskus 200 mikrograma/dozi, prašak not available UP/I /12- GLAXOSMITHKLINE D.O.O. HR inhalata, dozirani 01/18 Ventoline 1 mg/ml lösning för nebulisator i not available GLAXO WELLCOME GMBH & CO. FI endosbehållare KG Ventoline 2 mg/ml lösning för nebulisator i not available GLAXO WELLCOME GMBH & CO. FI endosbehållare KG Ventoline Diskus 200 mikrog/dos not available GLAXOSMITHKLINE OY FI inhalationspulver, avdelad dos Ventoline Evohaler 0,1 mg/dos inhalationsspray, not available GLAXOSMITHKLINE OY FI suspension Ventoline 2 mg tablett not available 6170 GLAXO OPERATIONS UK LTD FI Ventoline 5 mg/ml lösning för nebulisator not available 6310 GLAXO OPERATIONS UK LTD FI Ventoline 0,4 mg/ml oral lösning not available 8427 GLAXOSMITHKLINE OY FI AEROLIN not available GLAXOSMITHKLINE AE GR Ventilan 0,4 mg/ml Xarope not available GLAXO WELLCOME VENTOLIN 2 mg tabletten not available GLAXOSMITHKLINE VENTOLIN 2 mg Tabletten not available GLAXOSMITHKLINE EMA/662335/2017 Page 5/19

6 VENTOLIN 4 mg tabletten not available GLAXOSMITHKLINE VENTOLIN 4 mg Tabletten not available GLAXOSMITHKLINE VENTOLIN 2 mg/5ml siroop not available GLAXOSMITHKLINE VENTOLIN 2 mg/5ml Sirup not available GLAXOSMITHKLINE VENTOLIN 100 Mikrogramm/Dosis not available GLAXOSMITHKLINE Druckgasinhalation, Suspension VENTOLIN 100 microgram/dosis aërosol, not available GLAXOSMITHKLINE suspensie VENTOLIN 5 mg/ml verneveloplossing not available GLAXOSMITHKLINE VENTOLIN 5 mg/ml Lösung für einen Vernebler not available GLAXOSMITHKLINE VENTOLIN 0,5 mg/ml oplossing voor injectie not available GLAXOSMITHKLINE VENTOLIN 0,5 mg/ml, Injektionslösung not available GLAXOSMITHKLINE VENTOLIN 1 mg/ml concentraat voor oplossing not available GLAXOSMITHKLINE voor infusie VENTOLIN 1 mg/ml, Konzentrat zur Herstellung not available GLAXOSMITHKLINE einer Infusionslösung VENTOLIN 2 mg/5ml siroop not available GLAXOSMITHKLINE VENTOLIN 2 mg/5ml Sirup not available GLAXOSMITHKLINE VENTOLIN 2 mg tabletten not available 0260/04/09/8376 GLAXOSMITHKLINE VENTOLIN 2 mg tabletten not available 0260/04/09/8376 GLAXOSMITHKLINE VENTOLIN 4 mg tabletten not available 0260/04/09/8377 GLAXOSMITHKLINE EMA/662335/2017 Page 6/19

7 VENTOLIN 4 mg tabletten not available 0260/04/09/8377 GLAXOSMITHKLINE VENTOLIN 0,5 mg/ml, Injektionslösung not available GLAXOSMITHKLINE ENTOLIN 1 mg/ml, Konzentrat zur Herstellung not available GLAXOSMITHKLINE einer Infusionslösung VENTOLIN 5 mg/ml verneveloplossing not available 260/04/05/8248 GLAXOSMITHKLINE VENTOLIN 5 mg/ml Lösung für einen Vernebler not available 260/04/05/8248 GLAXOSMITHKLINE VENTOLIN 100 microgram/dosis aërosol, not available 260/09/02/0259 GLAXOSMITHKLINE suspensie VENTOLIN 100 Mikrogramm/Dosis not available 260/09/02/0259 GLAXOSMITHKLINE Druckgasinhalation, Suspension VENTOLIN 2 mg tablete not available H/94/01629/001 GLAXOSMITHKLINE D.O.O. SI VENTOLIN 2 mg/5 ml sirup not available H/94/01629/002 GLAXOSMITHKLINE D.O.O. SI VENTOLIN 5 mg/ml inhalacijska raztopina za not available H/94/01629/004 GLAXOSMITHKLINE D.O.O. SI nebulator VENTOLIN 100 mikrogramov/vpih inhalacijska not available H/94/01629/003 GLAXOSMITHKLINE D.O.O. SI suspenzija pod tlakom Ventolin 0,5 mg/ml soluţie injectabilă not available 7826/2015/01 GLAXO WELLCOME LTD RO Ventolin Evohaler 100 micrograms not available PL 10949/0274 GLAXO WELLCOME UK LTD UK TRADING AS GLAXOSMITHKLINE UK Ventolin Syrup not available PL 10949/0088 GLAXO WELLCOME LTD UK Ventolin Solution for Intravenous Infusion 5mg not available PL 10949/0087 GLAXO WELLCOME LTD UK in 5ml (1mg/ml) Ventolin Accuhaler 200 micrograms not available PL 10949/0252 GLAXO WELLCOME UK LTD UK TRADING AS GLAXOSMITHKLINE UK Ventolin Respirator Solution 5 mg/ml not available PL 10949/0244 GLAXO WELLCOME UK LIMITED UK Ventolin Respirator Solution not available MA167/01102 GLAXO WELLCOME UK LIMITED MT Ventolin Syrup not available MA 167/01103 GLAXO WELLCOME UK LIMITED MT EMA/662335/2017 Page 7/19

8 Sultanol - Dosieraerosol not available GLAXOSMITHKLINE PHARMA AT GMBH. VENTOLIN 0,5 mg/ml solution injectable not available GLAXOSMITHKLINE Sultanol-Ampullen not available GLAXOSMITHKLINE PHARMA AT GMBH. Салбутамол Инхалер 100 микрограма/дозирано not available GLAXO GROUP LIMITED BG впръскване, суспензия под налягане за инхалация Ventolin 2 mg/5 ml sirupas not available LT/1/96/1341/001 GLAXOSMITHKLINE LIETUVA LT UAB Sultanol - Inhalationslösung not available GLAXOSMITHKLINE PHARMA AT GMBH. Ventoline 2 mg tabletti not available 6170 GLAXO OPERATIONS UK LTD FI Sultanol Dosier-Aerosol 100 Mikrogramm/Dosis not available GLAXOSMITHKLINE GMBH & CO. DE Druckgasinhalation, Suspension KG Ventolin 5 mg/ml verneveloplossing not available RVG GLAXOSMITHKLINE B.V. NL Ventolin 5,0 Nebules, verneveloplossing 2 mg/ml not available RVG GLAXOSMITHKLINE B.V. NL VENTOLIN 4 mg comprimés not available GLAXOSMITHKLINE VENTOLIN 2 mg/5ml sirop not available GLAXOSMITHKLINE VENTOLIN 5 mg/ml - solution pour inhalation par not available GLAXOSMITHKLINE nébuliseur VENTOLIN 1 mg/ml solution à diluer pour not available GLAXOSMITHKLINE perfusion AEROLIN not available 6452/10/ GLAXOSMITHKLINE AE GR AEROLIN not available 81466/10/ GLAXOSMITHKLINE AE GR 2011 Ventolin 5 mg/ml solución para inhalación por not available GLAXOSMITHKLINE S.A. ES nebulizador Ventolin, 1 mg/ml (0,1%), roztwor do nebulizacji not available 4540 GLAXOSMITHKLINE EXPORT LTD PL Sultanol-Diskus 0,2 mg-pulver zur Trockeninhalation not available GLAXOSMITHKLINE PHARMA GMBH. AT EMA/662335/2017 Page 8/19

9 Salbutamol GSK 100 mikrogrami/devā aerosols not available GLAXOSMITHKLINE LATVIA SIA LV inhalācijām, zem spiediena, suspensija Ventolin 2,5 mg/2,5 ml purškiamasis not available LT/1/94/1341/003 GLAXOSMITHKLINE LIETUVA LT įkvepiamasis tirpalas UAB Ventoline 5 mg/ml lösning för nebulisator not available 8844 GLAXOSMITHKLINE AB SE Sultanol-Saft not available GLAXOSMITHKLINE PHARMA AT GMBH. VENTOLIN 100 mikrogrami/devā aerosols not available GLAXOSMITHKLINE LATVIA SIA LV inhalācijām, zem spiediena, suspensija Ventolin, 5 milligrammi/milliliitris nebuliseeritav not available GLAXO WELLCOME LTD EE lahus Ventolin 4 mg comprimés not available GLAXOSMITHKLINE VENTOLIN 100 microgrammes/dose suspension not available GLAXOSMITHKLINE pour inhalation en flacon pressurisé VENTOLIN 2 mg/5ml sirop not available GLAXOSMITHKLINE Ventolin 2 mg comprimés not available GLAXOSMITHKLINE Вентолин Сироп 2 mg/5 ml сироп not available GLAXOSMITHKLINE EOOD BG Вентолин Pазтвор 5 mg/ml, разтвор за not available GLAXOSMITHKLINE EOOD BG небулизатор Вентолин Инхалер 100 микрограма/дозирано not available GLAXOSMITHKLINE EOOD BG впръскване, суспензия под налягане за инхалация AEROLIN not available GLAXOSMITHKLINE AE GR AEROLIN not available GLAXOSMITHKLINE AE GR VENTOLIN 5 mg/ml šķīdums izsmidzināšanai not available GLAXOSMITHKLINE LATVIA SIA LV Ventolin 2mg/5ml sīrups not available GLAXOSMITHKLINE LATVIA SIA LV Ventoline Diskus 200 mikrog/annos not available GLAXOSMITHKLINE OY FI inhalaatiojauhe, annosteltu Ventilan-Inalador 100 microgramas/dose Suspensão pressurizada para inalação not available GLAXO WELLCOME EMA/662335/2017 Page 9/19

10 Ventolin, 100 µg/dawky inhalacyjrni, aerozol not available 4420 GLAXOSMITHKLINE EXPORT LTD PL inhalacyjny, zawiesina Ventoline not available 6005 GLAXOSMITHKLINE PHARMA A/S DK Ventoline not available 6153 GLAXOSMITHKLINE PHARMA A/S DK Ventolin Sirup not available 14/218/72-C GLAXO GROUP LIMITED CZ Ventoline Evohaler 0,1 mg/annos not available GLAXOSMITHKLINE OY FI inhalaatiosumute, suspensio Ventoline 5 mg/ml sumutinliuos not available 6310 GLAXO OPERATIONS UK LTD FI Ventoline 0,4 mg/ml oraaliliuos not available 8427 GLAXOSMITHKLINE OY FI Ventolin Diskus, 200 mikrogrammi/annuses, not available GLAXO WELLCOME LTD EE inhalatsioonipulber mitmeannuselises pulberinhalaatoris Ventolin, 100 mikrogrammi/annuses, annustatud not available GLAXO GROUP LIMITED EE inhalatsiooniaerosool, suspensioon Ventolin 500 mikrogramų/ml injekcinis tirpalas not available LT/1/94/1341/005 GLAXOSMITHKLINE LIETUVA LT UAB Ventolin 100 mikrogramų/išpurškime suslėgtoji not available LT/1/94/1341/002 GLAXOSMITHKLINE LIETUVA LT įkvepiamoji suspensija UAB Salbutamol GSK 100 mikrogramų/išpurškime not available LT/1/95/1339/001 GLAXOSMITHKLINE LIETUVA LT suslėgtoji įkvepiamoji suspensija UAB Ventolin 2,5 mg/2,5 ml purškiamasis not available LT/1/94/1341/004 GLAXOSMITHKLINE LIETUVA LT įkvepiamasis tirpalas UAB Sultanol Fertiginhalat 1,25 mg/2,5 ml Lösung not available GLAXOSMITHKLINE GMBH & CO. DE für einen Vernebler KG Sultanol forte Fertiginhalat 2,5 mg/2,5 ml not available GLAXOSMITHKLINE GMBH & CO. DE Lösung für einen Vernebler KG Sultanol Inhalationslösung 5 mg/1 ml Lösung not available GLAXOSMITHKLINE GMBH & CO. DE für einen Vernebler KG Ventolin 100 Volumatic CFK-vrij, aërosol, not available RVG GLAXOSMITHKLINE B.V. NL suspensie 100 microgram/dosis Ventolin Infuus, concentraat voor oplossing voor not available RVG GLAXOSMITHKLINE B.V. NL infusie 5 mg/5 ml Ventolin Injectie, oplossing voor injectie 0,5 mg/ml not available RVG GLAXOSMITHKLINE B.V. NL EMA/662335/2017 Page 10/19

11 Ventolin 100 Inhalator CFK-vrij, aërosol, not available RVG GLAXOSMITHKLINE B.V. NL suspensie 100 microgram/dosis Ventolin 100 Babyhaler CFK-vrij, aërosol, not available RVG GLAXOSMITHKLINE B.V. NL suspensie 100 microgram/dosis Ventolin 2,5 Nebules, verneveloplossing 1 mg/ml not available RVG GLAXOSMITHKLINE B.V. NL Ventolin Diskus 200 microgram/dosis - not available RVG GLAXOSMITHKLINE B.V. NL inhalatiepoeder, voorverdeeld VENTOLIN 1 mg/ml solution à diluer pour not available GLAXOSMITHKLINE perfusion VENTOLIN 0,5 mg/ml solution injectable not available GLAXOSMITHKLINE VENTOLIN 2 mg comprimés not available GLAXOSMITHKLINE VENTOLIN Nebules 1 mg/ml, solution pour not available 0260/ GLAXOSMITHKLINE inhalation par nébuliseur VENTOLIN Nebules 2 mg/ml, solution pour not available 0260/ GLAXOSMITHKLINE inhalation par nébuliseur VENTOLIN 5 mg/ml - solution pour inhalation par not available GLAXOSMITHKLINE nébuliseur VENTOLIN 100 microgrammes/dose suspension not available 260/09/02/0259 GLAXOSMITHKLINE pour inhalation en flacon pressurisé Ventilan 4 mg comprimidos not available GLAXO WELLCOME Ventilan 5 mg/ml solução para inalação por not available GLAXO WELLCOME nebulização Ventilan Rotacaps 400 microgramas Pó para not available GLAXO WELLCOME inalação, cápsula VENTILAN 4 mg comprimidos not available GLAXO WELLCOME Ventilan Rotacaps 200 microgramas Pó para not available GLAXO WELLCOME inalação, cápsula Ventilan 0,5 mg/1 ml solução injetável not available GLAXO WELLCOME Ventilan 5 mg/5 ml solução para perfusão not available GLAXO WELLCOME EMA/662335/2017 Page 11/19

12 Ventoline 2 mg tabletter not available 8583 GLAXOSMITHKLINE AB SE Ventolin 100 Inhaler CFC-Free, 100 not available 675/2008/01 GLAXO WELLCOME LTD RO micrograme/doză, suspensie de inhalat presurizată Ventolin 5 mg/ml, soluţie de inhalat prin not available 3337/2003/01-02 GLAXO WELLCOME LTD RO nebulizator Ventolin 100 microgramos/inhalación suspensión not available GLAXOSMITHKLINE S.A. ES para inhalación en envase a presión* (*) sin CFC Ventolin 0,5 mg/ml solución inyectable not available GLAXOSMITHKLINE S.A. ES Ventolin Dysk, 200 μg/dawkę inhalacyjną, not available 9119 GLAXOSMITHKLINE EXPORT LTD PL proszek do inhalacji Ventolin, 2 mg/ml (0,2%), roztwor do nebulizacji not available 4541 GLAXOSMITHKLINE EXPORT LTD PL Ventolin Syrup not available GLAXO GROUP LIMITED CY Ventolin Evohaler not available GLAXO GROUP LIMITED CY Ventoline, tabletter not available 6579 GLAXOSMITHKLINE PHARMA A/S DK Ventoline not available 9211 GLAXOSMITHKLINE PHARMA A/S DK Ventoline not available GLAXOSMITHKLINE PHARMA A/S DK Ventoline not available 5596 GLAXOSMITHKLINE PHARMA A/S DK Ventoline, koncentrat til infusionsvæske, not available GLAXOSMITHKLINE PHARMA A/S DK opløsning Ventoline not available GLAXOSMITHKLINE PHARMA A/S DK VENTOLINE 1,25 mg/2,5 ml, solution pour not available NL25939 LABORATOIRE FR inhalation par nébuliseur en récipient unidose GLAXOSMITHKLINE S.A.S. VENTOLINE 2,5 mg/2,5 ml, solution pour not available NL24701 LABORATOIRE FR inhalation par nébuliseur en récipient unidose GLAXOSMITHKLINE S.A.S. VENTOLINE 0,5 mg/1 ml, solution injectable par not available VNL9682 LABORATOIRE FR voie sous-cutanée en ampoule GLAXOSMITHKLINE S.A.S. SALBUMOL 0,5 mg/1 ml, solution injectable not available VNL14674 LABORATOIRE FR GLAXOSMITHKLINE S.A.S. VENTOLINE 5 mg/2,5 ml, solution pour inhalation par nébuliseur en récipient unidose not available NL24700 LABORATOIRE GLAXOSMITHKLINE S.A.S. FR EMA/662335/2017 Page 12/19

13 SALBUMOL FORT 5 mg/5 ml, solution pour not available VNL9684 LABORATOIRE FR perfusion intraveineuse en ampoule GLAXOSMITHKLINE S.A.S. VENTOLINE 2 mg/5 ml, sirop not available VNL10293 LABORATOIRE FR GLAXOSMITHKLINE VENTOLINE 100 microgrammes/dose, suspension not available NL22569 LABORATOIRE FR pour inhalation en flacon pressurisé GLAXOSMITHKLINE S.A.S. Ventolin Evohaler túlnyomásos inhalációs not available OGYI-T-7232/01 GLAXOSMITHKLINE KFT. HU szuszpenzió VENTOLIN 2 mg/10 ml Sciroppo not available GLAXOSMITHKLINE S.P.A. IT VENTOLIN 100 mcg Sospensione pressurizzata not available GLAXOSMITHKLINE S.P.A. IT per inalazione VENTOLIN 500 mcg/1 ml Soluzione iniettabile not available GLAXOSMITHKLINE S.P.A. IT VENTOLIN 100 mcg/5 ml Soluzione iniettabile not available GLAXOSMITHKLINE S.P.A. IT Ventolin 2 mg/5 ml sirup not available 14/0218/72-C/S GLAXO GROUP LIMITED SK Ventolin 5 mg/1 ml roztok na rozprašovanie not available 14/0219/72-C/S GLAXO GROUP LIMITED SK Ventolin Inhaler N 100 µg/1 dávka inhalačná not available 14/0551/70-C/S GLAXO GROUP LIMITED SK suspenzia v tlakovom obale Ventoline 2 mg/ml lausn fyrir eimgjafa not available (IS) GLAXOSMITHKLINE PHARMA A/S IS Ventoline Diskos not available GLAXOSMITHKLINE PHARMA A/S IS Ventoline 1 mg/ml lausn fyrir eimgjafa not available (IS) GLAXOSMITHKLINE PHARMA A/S IS Ventolin 2 mg/5 ml jarabe not available GLAXOSMITHKLINE S.A. ES Ventoline Diskus 0,2 mg/dos inhalationspulver, not available GLAXOSMITHKLINE AB SE avdelad dos Ventoline Evohaler 0,1 mg/dos inhalationsspray not available GLAXOSMITHKLINE AB SE suspension Ventoline 0,2 mg/dose inhalasjonspulver, not available GLAXOSMITHKLINE AS NO dosedispensert (diskus) Ventoline 0,4 mg/ml mikstur not available 5764 GLAXOSMITHKLINE AS NO Ventolin Nebules 2.5mg/2.5ml Nebuliser Solution not available PA 1077/49/5 GLAXOSMITHKLINE (IRELAND) IE LIMITED Ventolin Inhaler N Suspenze k inhalaci v tlakovém not available 14/869/99-C GLAXO GROUP LIMITED CZ obalu Ventoline 2 mg/ml lösning för nebulisator not available GLAXOSMITHKLINE AB SE EMA/662335/2017 Page 13/19

14 Ventoline 0,4 mg/ml oral lösning not available 8737 GLAXOSMITHKLINE AB SE Ventoline 1 mg/ml lösning för nebulisator not available 9880 GLAXOSMITHKLINE AB SE Ventilan Rotacaps 200 microgramas Pó para not available GLAXO WELLCOME inalação, cápsula Ventolin 4 mg comprimidos not available GLAXOSMITHKLINE S.A. ES Ventilan Rotacaps 400 microgramas Pó para not available GLAXO WELLCOME inalação, cápsula Ventolin Injection 500 micrograms (0.5mg) in not available PL 10949/0084 GLAXO WELLCOME LTD UK 1ml Ventolin Nebules 2.5 mg not available PL10949/0085 GLAXO WELLCOME UK LTD UK TRADING AS GLAXOSMITHKLINE UK Ventolin Nebules 5 mg not available PL10949/0086 GLAXO WELLCOME UK LTD UK TRADING AS GLAXOSMITHKLINE UK Ventolin Nebules 5mg/2.5ml Nebuliser Solution not available PA 1077/49/9 GLAXOSMITHKLINE (IRELAND) IE LIMITED Ventolin 1mg/ml Concentrate for Solution for not available PA 1077/49/2 GLAXOSMITHKLINE (IRELAND) IE Intravenous Infusion LIMITED Ventolin 500 micrograms/ml Solution for Injection not available PA 1077/49/1 GLAXOSMITHKLINE (IRELAND) IE LIMITED Ventolin Diskus 200 micrograms, Inhalation not available PA 1077/49/11 GLAXOSMITHKLINE (IRELAND) IE Powder, pre-dispensed. LIMITED Ventolin 2mg/5ml Oral Solution not available PA 1077/49/12 GLAXOSMITHKLINE (IRELAND) IE LIMITED Ventolin Evohaler 100 micrograms Pressurised not available PA 1077/49/10 GLAXOSMITHKLINE (IRELAND) IE Inhalation, Suspension LIMITED Ventolin Nebules 2.5mg not available GLAXO GROUP LIMITED CY Ventolin Diskus not available GLAXO GROUP LIMITED CY Ventoline 1 mg/ml inhalasjonsvæske til not available 6969 GLAXOSMITHKLINE AS NO nebulisator, oppløsning Ventoline 2 mg/ml inhalasjonsvæske til not available 7488 GLAXOSMITHKLINE AS NO nebulisator, oppløsning Ventoline 5 mg/ml inhalasjonsvæske til not available 5913 GLAXOSMITHKLINE AS NO EMA/662335/2017 Page 14/19

15 nebulisator, oppløsning Ventoline 0,5 mg/ml inhalasjonsvæske til not available 7819 GLAXOSMITHKLINE AS NO nebulisator, oppløsning Ventoline 0,1 mg/skammt innúðalyf, dreifa not available (IS) GLAXOSMITHKLINE PHARMA A/S IS Ventilan 0,4 mg/ml Xarope not available GLAXO WELLCOME Ventolin Evohaler 100 micrograms not available MA 167/01101 GLAXO WELLCOME UK LTD MT TRADING AS GLAXOSMITHKLINE UK Ventoline 2 mg/ml sumutinliuos not available GLAXOSMITHKLINE OY FI Ventoline 1 mg/ml sumutinliuos not available GLAXOSMITHKLINE OY FI VENTOLIN DISKUS 200 microgrammes/dose, not available 0260/ GLAXOSMITHKLINE poudre pour inhalation en récipient unidose Airomir 100 microgram, aërosol, suspensie not available UCB PHARMA S.A. (ANDERL ) Airomir Autohaler 100 microgram, aërosol, not available UCB PHARMA S.A. (ANDERL ) suspensie Airomir 100 microgrammes, suspension pour not available 0072/ UCB PHARMA S.A. (ANDERL ) inhalation en flacon pressurisé Airomir Autohaler 100 microgrammes, suspension not available 0072/ UCB PHARMA S.A. (ANDERL ) pour inhalation en flacon pressurisé. Airomir 100 microgrammes, suspension pour not available UCB PHARMA S.A. (ANDERL ) inhalation en flacon pressurisé Airomir Autohaler 100 microgrammes, suspension not available UCB PHARMA S.A. (ANDERL ) pour inhalation en flacon pressurisé Salamol Easi-Breathe CFC-Free Inhaler 100 UK/H/0450/001/MR PL 00530/0556 NORTON HEALTHCARE LTD T/A UK micrograms Pressurised Inhalation, suspension. IVAX PHARMACEUTICALS UK Salamol UK/H/0450/001/MR TEVA DENMARK A/S DK Salbulair N 100 Mikrogramm Easi-Breathe UK/H/0450/001/MR TEVA GMBH DE Druckgasinhalation, Suspension Salbutamol 100 Redihaler 100 microgram/dosis, UK/H/0450/001 RVG TEVA NEDERLAND B.V. NL aërosol, suspensie Buventol Easyhaler 200 mikrogram/dos inhalationspulver not available ORION CORPORATION SE EMA/662335/2017 Page 15/19

16 Buventol Easyhaler 100 mikrogram/dos not available ORION CORPORATION SE inhalationspulver Salbu Novolizer not available MEDA PHARMA GMBH & CO. KG DE 100 Mikrogramm, Pulver zur Inhalation Salbuair 2.5 mg solución para inhalación por not available LABORATORIO ALDO-UNIÓN, ES nebulizador S.L. Salbuair 5 mg solución para inhalación por not available LABORATORIO ALDO-UNIÓN, ES nebulizador S.L. VENTOALDO 100 microgramos/dosis suspension not available LABORATORIO ALDO-UNIÓN, ES para inhalación en envase a presión S.L. Easyhaler Salbutamol Sulfate 100 micrograms per not available PL27925/0002 ORION CORPORATION UK actuation inhalation powder Easyhaler Salbutamol Sulfate 200 micrograms per not available PL27925/0003 ORION CORPORATION UK actuation inhalation powder Broncovaleas 2 mg/5 ml sciroppo not available VALEAS S.P.A. IT Broncovaleas 5mg/ml soluzione da nebulizzare not available VALEAS S.P.A. IT Broncovaleas 100 microgrammi/spruzzo not available VALEAS S.P.A. IT sospensione pressurizzata per inalazione Broncovaleas 2 mg compresse not available VALEAS S.P.A. IT Salbutamol MDPI Novolizer 100 DE/H/0864/ MEDA PHARMA GMBH & CO. KG DE Mikrogramm/Dosis Pulver zur Inhalation Salbulin MDPI Novolizer 100 micrograms / dose DE/H/0864/001 PL 15142/0111 MEDA PHARMACEUTICALS LTD UK inhalation powder Ventamol CFC-Free 100 micrograms Pressurised not available PA 436/8/10 NORTON WATERFORD T/A IVAX IE Inhalation, Suspension PHARMACEUTICALS IRELAND BUVENTOL EASYHALER 200 μg/dose, dávkovaný not available 14/090/97-C ORION CORPORATION CZ prášek k inhalaci BUVENTOL EASYHALER 100 µg/dose, not available 14/089/97-C ORION CORPORATION CZ DÁVKOVANÝ PRÁŠEK K INHALACI Salbu Easyhaler 0,2 mg/dosis Pulver zur not available ORION CORPORATION DE Inhalation Salbu Easyhaler 0,1 mg/dosis Pulver zur not available ORION CORPORATION DE Inhalation Salbutamol Pliva 100 mikrograma po potisku, not available UP/I /13- PLIVA HRVATSKA D.O.O. HR EMA/662335/2017 Page 16/19

17 stlačeni inhalat, suspenzija 02/319 Ecosal Easi-Breath 100 mikrograma/dozi slačeni not available UP/I /13- PLIVA HRVATSKA D.O.O. HR inhalat, suspenzija 02/318 Salbutamol Pliva 2 mg/5 ml sirup not available HR-H PLIVA HRVATSKA D.O.O. HR Airomir inhalator, aerosol 100 microgram/dosis not available RVG TEVA NEDERLAND B.V. NL Salbulair N 100 μg Autohaler not available TEVA GMBH DE Druckgasinhalation, Suspension Airomir Autohaler not available RVG TEVA NEDERLAND B.V. NL Salbutamol 100 Novolizer 100 Mikrogramm/Dosis DE/H/1027/ MEDA PHARMA GMBH & CO. KG DE Pulver zur Inhalation Ventilastin Novolizer 100 mikrogramov/odmerek DE/H/1027/001 H/09/01628/005 MEDA PHARMA GMBH & CO. KG SI prašek za inhaliranje Ventilastin Novolizer 100 mikrogramov/odmerek DE/H/1027/001 H/09/01628/004 MEDA PHARMA GMBH & CO. KG SI prašek za inhaliranje Вентиластин Новолайзер 100 микрограма/за DE/H/1027/ MEDA PHARMA GMBH & CO. KG BG доза прах за инхалация Ventilastin Novolizer, 100 μικρογραμμάρια/δόση DE/H/1027/ / MEDA PHARMACEUTICALS S.A. GR κόνις για εισπνοή Ventilastin Novolizer 100 micrograme/doză DE/H/1027/ /2012/ MEDA PHARMA GMBH & CO. KG RO pulbere de inhalat Ventilastin Novolizer 100 mikrogramov / DE/H/1027/001 14/0067/10-S MEDA PHARMA SPOL. S R.O. SK dávkovací inhalačný prášok Ventilastin Novolizer, 100 mikrogramów/dawkę, DE/H/1027/ MEDA PHARMA GMBH & CO. KG PL proszek do inhalacji Ventilastin Novolizer 100 mikrogramov/odmerek DE/H/1027/001 H/09/01628/001 MEDA PHARMA GMBH & CO. KG SI prašek za inhaliranje Ventilastin Novolizer 100 mikrogramų/dozėje DE/H/1027/001 LT/1/10/2119/002 MEDA PHARMA GMBH & CO. KG LT inhaliaciniai milteliai Ventilastin Novolizer 100 mikrogramų/dozėje DE/H/1027/001 LT/1/10/2119/001 MEDA PHARMA GMBH & CO. KG LT inhaliaciniai milteliai Ventilastin Novolizer 100 mikrogramov/odmerek DE/H/1027/001 H/09/01628/002 MEDA PHARMA GMBH & CO. KG SI prašek za inhaliranje Ventilastin Novolizer 100 mikrogramų/dozėje inhaliaciniai milteliai DE/H/1027/001 LT/1/10/2119/004 MEDA PHARMA GMBH & CO. KG LT EMA/662335/2017 Page 17/19

18 Ventilastin Novolizer 100 mikrogramų/dozėje DE/H/1027/001 LT/1/10/2119/003 MEDA PHARMA GMBH & CO. KG LT inhaliaciniai milteliai Ventilastin Novolizer 100 mikrogramų/dozėje DE/H/1027/001 LT/1/10/2119/005 MEDA PHARMA GMBH & CO. KG LT inhaliaciniai milteliai Ventilastin Novolizer 100 mikrogramov/odmerek DE/H/1027/001 H/09/01628/003 MEDA PHARMA GMBH & CO. KG SI prašek za inhaliranje Ventilastin Novolizer, 100 mikrogrammi/annuses DE/H/1027/ MEDA PHARMA GMBH & CO. KG EE inhalatsioonipulber Ventilastin Novolizer 100 mikrogrami/ devā DE/H/1027/ MEDA PHARMA GMBH & CO. KG LV inhalācijas pulveris Salbutamol TEVA, inhalationsvæske til DE/H/1187/ TEVA DENMARK A/S DK nebulisator, opløsning Airomir 1 mg/ml lösning för nebulisator DE/H/1187/ TEVA SWEDEN AB SE Salamol Steri-Neb 5 mg/2,5 ml,verneveloplossing DE/H/1187/002 RVG TEVA B.V NL SALBUTAMOL TEVA 2,5 mg/2,5 ml, solution pour DE/H/1187/001 NL34457 TEVA SANTÉ FR inhalation par nébuliseur en récipient unidose Salbutamol-TEVA 5 mg/2,5 ml Lösung für einen DE/H/1187/ TEVA GMBH DE Vernebler SALBUTAMOL TEVA 5 mg/2,5 ml, solution pour DE/H/1187/02 NL34458 TEVA SANTÉ NL inhalation par nébuliseur en récipient unidose Salbutamol-TEVA 2,5 mg/2,5 ml Lösung für einen DE/H/1187/ TEVA GMBH DE Vernebler Salamol Steri-Neb 2,5 mg/2,5 ml, DE/H/1187/001 RVG TEVA GMBH DE verneveloplossing Salbutamol/Teva 2,5 mg/2,5 ml Διάλυμα για DE/H/1187/ / TEVA PHARMA B.V. GR Εισπνοή με Εκνεφωτή Salbutamol/Teva 5 mg/2,5 ml Διάλυμα για DE/H/1187/ / TEVA PHARMA B.V. GR Εισπνοή με Εκνεφωτή Salbutamol Teva DE/H/1187/ TEVA DENMARK A/S DK Airomir 2 mg/ml lösning för nebulisator DE/H/1187/ TEVA SWEDEN AB SE VENTMAX 200 microgrammi POLVERE per not available CHIESI FARMACEUTICI S.P.A. IT inalazione VENTMAX 5 mg/2 ml soluzione da nebulizzare not available CHIESI FARMACEUTICI S.P.A. IT EMA/662335/2017 Page 18/19

19 VENTMAX 2.5 mg/2 ml soluzione da nebulizzare not available CHIESI FARMACEUTICI S.P.A. IT Buventol Easyhaler 200 mikrogramm/adag not available OGYI-T-5752/01 ORION CORPORATION HU inhalációs por BUVENTOL EASYHALER 200 mikrogram/dose not available ORION CORPORATION NO inhalasjonspulver BUVENTOL EASYHALER 100 mikrogram/dose inhalasjonspulver not available ORION CORPORATION NO EMA/662335/2017 Page 19/19