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Levosalbutamol, Salbutamol: List of Nationally Authorised Medicinal Products

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Levosalbutamol, Salbutamol: List of Nationally Authorised Medicinal Products 1 October 2020 EMA/558447/2020 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: levosalbutamol, salbutamol Procedure no.: PSUSA/00010330/202001 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised AEROLIN not available 0332516 GLAXOSMITHKLINE AEBE GR AEROLIN not available 0332517 GLAXOSMITHKLINE AEBE GR AEROLIN not available 0332505 GLAXOSMITHKLINE AEBE GR AEROLIN not available 0332514 GLAXOSMITHKLINE AEBE GR AEROLIN not available 6452/10/14-6-11 GLAXOSMITHKLINE AEBE GR Airomir 1 mg/ml lösning DE/H/1187/001 25619 TEVA SWEDEN AB SE för nebulisator Airomir 100 microgram, not available BE166266 TEVA B.V BE aerosol, suspensie Airomir 100 not available 2005108292 TEVA B.V LU microgrammes, suspension pour inhalation en flacon pressurisé. Airomir 2 mg/ml lösning DE/H/1187/002 25620 TEVA SWEDEN AB SE för nebulisator List of nationally authorised medicinal products EMA/558447/2020 Page 2/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Airomir Autohaler not available RVG 22393 TEVA NEDERLAND B.V. NL Airomir Autohaler 100 not available BE166275 TEVA B.V BE microgram, aerosol, suspensie Airomir Autohaler 100 not available 2005108293 TEVA B.V LU microgrammes, suspension pour inhalation en flacon pressurisé. AIROMIR AUTOHALER 100 not available NL20590 TEVA SANTÉ FR microgrammes/dose, suspension pour inhalation en flacon pressurisé Airomir inhalator, aerosol not available RVG 18353 TEVA NEDERLAND B.V. NL 100 microgram/dosis Airsalb 0,1mg/dos SE/H/0603/001 24850 SANDOZ A/S SE inhalationsspray, suspension AirSalb CFC-free inhaler SE/H/0601/001 PL 04416/0785 SANDOZ LTD UK 100 microgram / dose Airsalb, inhalationsspray, SE/H/0601/001 40434 SANDOZ A/S DK suspension List of nationally authorised medicinal products EMA/558447/2020 Page 3/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Asthalin 100 micrograms not available PL 36390/0034 CIPLA (EU) LIMITED UK Inhaler Brodilaten 1,25 mg / 2,5 IE/H/0713/001 3163301 DEMO ABEE GR mL Διάλυμα για εισπνοή με εκνεφωτή Brodilaten 1.25 mg / 2.5 IE/H/0713/001 PA1122/024/001 NORIDEM ENTERPRISES LTD IE mL Nebuliser solution Brodilaten 1.25 mg / 2.5 IE/H/0713/001 PL 24598/0076 NORIDEM ENTERPRISES LTD UK mL Nebuliser solution Brodilaten 2,5 mg / 2,5 IE/H/0713/002 3163302 DEMO ABEE GR mL Διάλυμα για εισπνοή με εκνεφωτή Brodilaten 2.5 mg / 2.5 IE/H/0713/002 PA1122/024/002 NORIDEM ENTERPRISES LTD IE mL Nebuliser solution Brodilaten 2.5 mg / 2.5 IE/H/0713/002 PL 24598/0077 NORIDEM ENTERPRISES LTD UK mL Nebuliser solution Brodilaten 5,0 mg / 2,5 IE/H/0713/003 3163303 DEMO ABEE GR mL Διάλυμα για εισπνοή με εκνεφωτή Brodilaten 5.0 mg / 2.5 IE/H/0713/003 PA1122/024/003 NORIDEM ENTERPRISES LTD IE mL Nebuliser solution List of nationally authorised medicinal products EMA/558447/2020 Page 4/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Brodilaten 5.0 mg / 2.5 IE/H/0713/003 PL 24598/0078 NORIDEM ENTERPRISES LTD UK mL Nebuliser solution Broncovaleas 100 not available 022991158 VALEAS S.P.A. IT microgrammi/spruzzo sospensione pressurizzata per inalazione Broncovaleas 2 mg not available 022991133 VALEAS S.P.A. IT compresse Broncovaleas 2 mg/5 ml not available 022991032 VALEAS S.P.A. IT sciroppo Broncovaleas 5mg/ml not available 022991 057 VALEAS S.P.A. IT soluzione da nebulizzare BUVENTOL EASYHALER not available 14/089/97-C ORION CORPORATION CZ 100 µg/dose, DÁVKOVANÝ PRÁŠEK K INHALACI Buventol Easyhaler 100 not available 11117 ORION OYJ FI mikrog/annos inhalaatiojauhe Buventol Easyhaler 100 not available 11117 ORION OYJ FI mikrog/dos inhalationspulver Buventol Easyhaler 100 not available 13120 ORION CORPORATION SE mikrogram/dos inhalationspulver List of nationally authorised medicinal products EMA/558447/2020 Page 5/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Buventol Easyhaler 200 not available 11118 ORION OYJ FI mikrog/annos inhalaatiojauhe Buventol Easyhaler 200 not available 11118 ORION OYJ FI mikrog/dos inhalationspulver Buventol Easyhaler 200 not available 13121 ORION CORPORATION SE mikrogram/dos inhalationspulver Buventol Easyhaler 200 not available OGYI-T-5752/01 ORION CORPORATION HU mikrogramm/adag inhalációs por BUVENTOL EASYHALER not available 14/090/97-C ORION CORPORATION CZ 200 μg/dose, dávkovaný prášek k inhalaci BUVENTOL EASYHALER, not available 516706 ORION CORPORATION EE 100 mikrogrammi/annuses inhaleeritav pulber BUVENTOL EASYHALER, not available 223298 ORION CORPORATION EE 200 mikrogrammi/annuses inhaleeritav pulber Buventol Easyhaler, not available 17288 ORION CORPORATION DK inhalationspulver Buventol Easyhaler, not available 17287 ORION CORPORATION DK inhalationspulver List of nationally authorised medicinal products EMA/558447/2020 Page 6/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised BUVENTOL® not available 94-2763 ORION CORPORATION NO EASYHALER® 100 mikrogram/dose inhalasjonspulver BUVENTOL® not available 94-2764 ORION CORPORATION NO EASYHALER® 200 mikrogram/dose inhalasjonspulver Easyhaler Salbutamol not available PL27925/0002 ORION CORPORATION UK Sulfate 100 micrograms per actuation inhalation powder Easyhaler Salbutamol not available PL27925/0003 ORION CORPORATION UK Sulfate 200 micrograms per actuation inhalation powder Ecosal Easi-Breath 100 not available UP/I-530-09/13-02/318 PLIVA HRVATSKA D.O.O. HR mikrograma/dozi slačeni inhalat, suspenzija ECOSAL Inhaler not available 14/439/00-C TEVA CZECH INDUSTRIES CZ Suspenze k inhalaci v S.R.O tlakovém obalu Novolizer Salbutamol 100 DE/H/0333/001 BE260793 MYLAN EPD BVBA/SPRL BE microgram/dosis, inhalatiepoeder Novolizer Salbutamol 100 DE/H/0333/001 BE260793 MYLAN EPD BVBA/SPRL BE microgrammes/dose, poudre pour inhalation List of nationally authorised medicinal products EMA/558447/2020 Page 7/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Novolizer Salbutamol 100 DE/H/0333/001 2005/080022 MYLAN EPD BVBA/SPRL LU microgrammes/dose, poudre pour inhalation. Novolizer Salbutamol 100 DE/H/0333/001 PA2010/033/001 MYLAN IRE HEALTHCARE IE micrograms / dose LIMITED inhalation powder Novolizer Salbutamol 100 DE/H/0333/001 BE260793 MYLAN EPD BVBA/SPRL BE Mikrogramm / Dosis Pulver zur Inhalation Novolizer Salbutamol 100 DE/H/0333/001 2005/080022 MYLAN EPD BVBA/SPRL LU Mikrogramm / Dosis Pulver zur Inhalation Novolizer Salbutamol DE/H/0333/001 1-25976 MEDA PHARMA GMBH AT Meda 100 Mikrogramm/Dosis Pulver zur Inhalation Sabumalin 100 SE/H/0601/001 24848 HEXAL AG SE micrograms/dose pressurised inhalation, suspension Sabumalin, 100 SE/H/0601/001 16434 SANDOZ GMBH PL mikrogramów/dawkę, aerozol inhalacyjny, zawiesina Salamol CFC-Free Inhaler UK/H/0449/001 PL 00530/0555 NORTON HEALTHCARE LTD UK 100 micrograms T/A IVAX PHARMACEUTICALS Pressurised Inhalation, UK suspension. List of nationally authorised medicinal products EMA/558447/2020 Page 8/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Salamol Easi-Breathe DE/H/6100/001 PL 00530/0556 NORTON HEALTHCARE LTD UK CFC-Free Inhaler 100 T/A IVAX PHARMACEUTICALS micrograms Pressurised UK Inhalation, suspension. Salamol, inhalationsspray, DE/H/6100/001 32849 TEVA B.V DK suspension Salbu Easyhaler 0,1 not available 32940.00.00 ORION CORPORATION DE mg/Dosis Pulver zur Inhalation Salbu Easyhaler 0,2 not available 32940.01.00 ORION CORPORATION DE mg/Dosis Pulver zur Inhalation Salbuair 2.5 mg solución not available 73.563 LABORATORIO ALDO-UNIÓN, ES para inhalación por S.L. nebulizador Salbuair 5 mg solución not available 73.562 LABORATORIO ALDO-UNIÓN, ES para inhalación por S.L. nebulizador SalbuHEXAL Fertiginhalat not available 17377.00.00 HEXAL AG DE 1,25 mg/2,5 ml Lösung für einen Vernebler SalbuHEXAL not available 17373.00.00 HEXAL AG DE Inhalationslösung 5 mg/ml Lösung für einen Vernebler SalbuHEXAL N SE/H/0602/001 67774.00.00 HEXAL AG DE Dosieraerosol List of nationally authorised medicinal products EMA/558447/2020 Page 9/39 Product Name (in MRP/DCP National Authorisation Number MAH of product in the Member State where authorisation country) Authorisation number member state product is authorised Salbul 100 SE/H/0602/001 PA0711/128/001 ROWEX LTD IE micrograms/dose pressurised inhalation, suspension Salbulair® N 100 DE/H/6100/001 52662.00.00 TEVA GMBH DE Mikrogramm Easi- Breathe® Druckgasinhalation, Suspension Salbulin MDPI Novolizer DE/H/0864/001 PL 46302/0191 MYLAN PRODUCTS LIMITED UK 100 micrograms / dose inhalation powder SALBUMOL 0,5 mg/1 ml, not available VNL14674 LABORATOIRE FR solution injectable GLAXOSMITHKLINE SALBUMOL FORT 5 mg/5 not available VNL9684 LABORATOIRE FR ml, solution pour GLAXOSMITHKLINE perfusion intraveineuse en ampoule Salbutamol - 1 A Pharma SE/H/0603/001 67868.00.00 1 A PHARMA GMBH DE 0,1 mg Druckgasinhalation, Suspension Salbutamol ”TEVA”, DE/H/1187/001 41493 TEVA B.V DK inhalationsvæske til nebulisator, opløsning Salbutamol 100 Novolizer DE/H/1027/001 63053.00.00 MEDA PHARMA GMBH & CO.
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