Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2016-07-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016277EN.01001101.xml










29.7.2016   


EN


Official Journal of the European Union


C 277/11





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 277/02)
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




29.6.2016


Inhaled corticosteroids


beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate


See Annex I


See Annex I


30.6.2016




10.6.2016


CattleMarker IBR Inactivated emulsion for injec


Inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac


See Annex II


See Annex II


13.6.2016




24.6.2016


Novantrone and associated names


mitoxantrone


See Annex III


See Annex III


27.6.2016




24.6.2016


Irbesartan


Irbesartan


Not applicable


Not applicable


27.6.2016




29.6.2016


Zoledronic acid


Zoledronic acid


Not applicable


Not applicable


30.6.2016






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
List of nationally authorised medicinal products









Member State in EEA


Marketing authorisaton holder


Product name


Active substance + Strength


Pharmaceutical form




Austria


3m Health Care Ltd


Aerocortin


Beclometasone Dipropionate 50 μg/50 μl


Pressurised Inhalation, Solution




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat


Fluticasone Propionate 50 μg Dose


Pressurised Inhalation, Suspension




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat Diskus Forte Allen


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat Diskus Junior Allen


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat ‘allen’


Fluticasone Propionate 125 μg Dose


Pressurised Inhalation, Suspension




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat ‘allen’


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Fluticasonpropionat ‘allen’


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Austria


Allen Pharmazeutika Gesellschaft M.B.H.


Samtoral Diskus Standard


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Austria


Astrazeneca österreich Gmbh


Pulmicort


Budesonide 400 μg Dose


Inhalation Powder




Austria


Astrazeneca österreich Gmbh


Pulmicort Turbohaler


Budesonide 100 μg Dose


Inhalation Powder




Austria


Astrazeneca österreich Gmbh


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Austria


Astrazeneca österreich Gmbh


Pulmicort Turbohaler


Budesonide 400 μg Dose


Inhalation Powder




Austria


Astrazeneca österreich Gmbh


Symbicort Forte Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Austria


Astrazeneca österreich Gmbh


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Austria


Chiesi Pharmaceuticals Gmbh


Budiair


Budesonide 0,2  mg/0,05 ml


Pressurised Inhalation, Solution




Austria


Chiesi Pharmaceuticals Gmbh


Budiair Jet


Budesonide 0,2  mg/0,05  ml


Pressurised Inhalation, Solution




Austria


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Austria


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Austria


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide


Fluticasone Propionate 125 μg Inhalation


Pressurised Inhalation, Suspension




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide Diskus Forte


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide Diskus Junior


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Austria


Glaxosmithkline Pharma Gmbh.


Flixotide Junior


Fluticasone Propionate 125 μg Inhalation


Pressurised Inhalation, Suspension




Austria


Glaxosmithkline Pharma Gmbh.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Austria


Pari Pharma Gmbh


Buparid


Budesonide 0,25  mg Ampoule


Nebuliser Suspension




Austria


Pari Pharma Gmbh


Buparid


Budesonide 0,5  mg Ampoule


Nebuliser Suspension




Austria


Pari Pharma Gmbh


Buparid


Budesonide 1 mg Ampoule


Nebuliser Suspension




Austria


Sandoz Gmbh


Airflusal Forspiro


Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder




Austria


Sandoz Gmbh


Airflusal Forspiro


Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder




Belgium


Chiesi Sa-Nv


Inuvair


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Belgium


Cipla Europe Nv


Salmeterol/Fluticasone Cipla


Salmeterol 25 μg/Dose; Fluticasone Propionate 125 μg/Dose


Pressurised Inhalation, Suspension




Belgium


Elpen Pharmaceutical Co. Inc.


Flusalio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Belgium


Elpen Pharmaceutical Co. Inc.


Flusalio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 0,05  mg/2ml


Nebuliser Solution




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 2 mg/2ml


Nebuliser Solution




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 50 μg Inhalation


Pressurised Inhalation, Suspension




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Belgium


Glaxosmithkline Pharmaceuticals S.A.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Belgium


Nv Astrazeneca Sa


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Belgium


Nv Astrazeneca Sa


Symbicort Forte Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Belgium


Nv Astrazeneca Sa


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Belgium


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Belgium


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Belgium


Pari Pharma Gmbh


Buparid


Budesonide 0,25  mg Ampoule


Nebuliser Suspension




Belgium


Pari Pharma Gmbh


Buparid


Budesonide 0,5  mg Ampoule


Nebuliser Suspension




Belgium


Pari Pharma Gmbh


Buparid


Budesonide 1 mg Ampoule


Nebuliser Suspension




Belgium


Sandoz N.V.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Bulgaria


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Bulgaria


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Bulgaria


Chiesi Pharmaceuticals Gmbh


Foster


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Bulgaria


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Bulgaria


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Bulgaria


Glaxosmithkline Eood


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Bulgaria


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Bulgaria


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Bulgaria


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Bulgaria


Sopharma Ad


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Croatia


Astrazeneca D.O.O


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Croatia


Astrazeneca D.O.O


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Croatia


Clinres Farmacija D.O.O.


Dimenium


Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Clinres Farmacija D.O.O.


Dimenium


Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Clinres Farmacija D.O.O.


Dimenium


Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Glaxosmithkline D.O.O.


Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Glaxosmithkline D.O.O.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Providens D.O.O.


Foster


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Croatia


Salvus D.O.O.


Saldisk


Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Salvus D.O.O.


Saldisk


Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Salvus D.O.O.


Saldisk


Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Sandoz D.O.O.


Airflusal Forspiro


Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder, Pre-Dispensed




Croatia


Sandoz D.O.O.


Airflusal Forspiro


Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Cyprus


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Cyprus


Costakis Tsisios & Co. Ltd


Fluticapen


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Fluticapen


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Pulmoton


Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Pulmoton


Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Pulmoton


Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Rolenium


Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Rolenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Costakis Tsisios & Co. Ltd


Rolenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Glaxo Group Limited


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Cyprus


Glaxo Group Limited


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Cyprus


Glaxo Group Limited


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Cyprus


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose


Inhalation Powder




Cyprus


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose


Inhalation Powder




Cyprus


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose


Inhalation Powder




Cyprus


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose


Inhalation Powder




Czech Republic


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Czech Republic


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Czech Republic


Chiesi Pharmaceuticals Gmbh


Combair


Formoterol Fumarate Dihydrate 1,08  Mg, Beclometasone Dipropionate 18 Mg


Pressurised Inhalation, Solution




Czech Republic


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Czech Republic


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Czech Republic


Glaxo Group Limited


Flixotide


Fluticasone Propionate 125 μg


Pressurised Inhalation, Suspension




Czech Republic


Glaxo Group Limited


Flixotide


Fluticasone Propionate 250 μg


Pressurised Inhalation, Suspension




Czech Republic


Glaxo Group Limited


Flixotide


Fluticasone Propionate 50 μg


Pressurised Inhalation, Suspension




Czech Republic


Glaxo Group Limited


Flixotide Diskus


Fluticasone Propionate 100 μg


Inhalation Powder




Czech Republic


Glaxo Group Limited


Flixotide Diskus


Fluticasone Propionate 250 μg


Inhalation Powder




Czech Republic


Glaxo Group Limited


Flixotide Diskus


Fluticasone Propionate 500 μg


Inhalation Powder




Czech Republic


Glaxo Group Limited


Seretide Diskus


Fluticasone Propionate 500 μg, Salmeterol Xinafoate 72,5  μg


Inhalation Powder




Czech Republic


Sandoz S.R.O.


Airflusan Forspiro


Fluticasone Propionate 0,25  Mg, Salmeterol Xinafoate 0,073  Mg


Inhalation Powder, Pre-Dispensed




Czech Republic


Sandoz S.R.O.


Airflusan Forspiro


Fluticasone Propionate 0,5  Mg, Salmeterol Xinafoate 0,073  Mg


Inhalation Powder, Pre-Dispensed




Denmark


Astrazeneca A-S


Symbicort Forte Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Denmark


Astrazeneca A-S


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Denmark


Chiesi Farmaceutici S.P.A.


Innovair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Denmark


Elpen Pharmaceutical Co. Inc.


Flusaterol


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Denmark


Elpen Pharmaceutical Co. Inc.


Flusaterol


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose


Inhalation Powder, Pre-Dispensed




Denmark


Glaxosmithkline Pharma A-S


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Denmark


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Denmark


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Denmark


Sandoz A-S


Airflusal Forspiro


Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder, Pre-Dispensed




Denmark


Sandoz A-S


Airflusal Forspiro


Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder, Pre-Dispensed




Estonia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Estonia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Estonia


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Estonia


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Estonia


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Estonia


Glaxo Wellcome Ltd


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Estonia


Glaxo Wellcome Ltd


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Estonia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Estonia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Finland


Astrazeneca Oy


Symbicort Forte Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Finland


Astrazeneca Oy


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Finland


Chiesi Farmaceutici S.P.A.


Innovair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Finland


Chiesi Farmaceutici S.P.A.


Innovair Nexthaler


Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose


Inhalation Powder




Finland


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Finland


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Finland


Glaxosmithkline Oy


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Finland


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Finland


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




France


Astrazeneca France


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




France


Astrazeneca France


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




France


Chiesi S.A.


Formodual


Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose


Pressurised Inhalation, Solution




France


Chiesi S.A.


Innovair


Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose


Pressurised Inhalation, Solution




France


Laboratoire Glaxosmithkline S.A.S.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


3m Health Care Ltd


Bronchocort Novo


Beclometasone Dipropionate 100 μg/50 μl


Pressurised Inhalation, Solution




Germany


3m Health Care Ltd


Junik


Beclometasone Dipropionate 100 μg Actuation


Pressurised Inhalation, Solution




Germany


Abz-Pharma Gmbh


Beclomethasone Dipropionate Ct


Beclometasone Dipropionate 0,05  mg/18,7  G


Pressurised Inhalation, Solution




Germany


Meda Pharma Gmbh & Co. Kg


Budecort Novolizer


Budesonide, Micronised 0,2  mg Actuation


Inhalation Powder




Germany


Meda Pharma Gmbh & Co. Kg


Budecort Novolizer


Budesonide, Micronised 0,4  mg Actuation


Inhalation Powder




Germany


Astrazeneca Gmbh


Pulmicort Budesonide


Budesonide 0,5  Mg


Nebuliser Suspension




Germany


Astrazeneca Gmbh


Pulmicort Budesonide


Budesonide 1,0  Mg


Nebuliser Suspension




Germany


Astrazeneca Gmbh


Pulmicort


Budesonide 400 μg Dose


Inhalation Powder




Germany


Astrazeneca Gmbh


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Germany


Astrazeneca Gmbh


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Germany


Astrazeneca Gmbh


Symbicort Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Germany


Chiesi Farmaceutici S.P.A.


Kantos


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Germany


Chiesi Farmaceutici S.P.A.


Kantos Master


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Germany


Chiesi Gmbh


Budiair


Budesonide 200 μg Spray


Pressurised Inhalation, Solution




Germany


Chiesi Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Germany


Chiesi Gmbh


Ribuvent


Budesonide 200 μg Puff


Pressurised Inhalation, Solution




Germany


Chiesi Gmbh


Sanasthmax


Beclometasone Dipropionate 250 μg/59,2  Mg


Pressurised Inhalation, Solution




Germany


Chiesi Gmbh


Sanasthmax Junior


Beclometasone Dipropionate 50 μg/59 Mg


Pressurised Inhalation, Solution




Germany


Elpen Pharmaceutical Co. Inc.


Flusalio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Elpen Pharmaceutical Co. Inc.


Flusalio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Glaxosmithkline Gmbh & Co. Kg


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Germany


Glaxosmithkline Gmbh & Co. Kg


Flixotide Forte


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Germany


Glaxosmithkline Gmbh & Co. Kg


Flixotide Forte Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Germany


Glaxosmithkline Gmbh & Co. Kg


Flutide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Glaxosmithkline Gmbh & Co. Kg


Flutide Forte


Fluticasone Propionate 220 μg Puff


Pressurised Inhalation, Suspension




Germany


Glaxosmithkline Gmbh & Co. Kg


Flutide Forte Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Glaxosmithkline Gmbh & Co. Kg


Viani Forte


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Germany


Heumann Pharma Gmbh & Co. Generica Kg


Budesonid


Budesonide 0,2  Mg


Inhalation Powder




Germany


Hexal Ag


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Germany


Hexal Ag


Budes N


Budesonide 0,2  mg Dose


Pressurised Inhalation, Solution




Germany


Janssen-Cilag Gmbh


Inuvair


Beclometasone Dipropionate 100 μg Inhalation, Formoterol Fumarate 6 μg Inhalation


Pressurised Inhalation, Solution




Germany


Meda Pharma Gmbh & Co. Kg


Budesonid Novolizer Meda Pharma Gmbh & Co. Kg


Budesonide 400 μg Inhalation


Inhalation Powder




Germany


Meda Pharma Gmbh & Co. Kg


Novopulmon Novolizer


Budesonide 200 μg Dose


Inhalation Powder




Germany


Meda Pharma Gmbh & Co. Kg


Novopulmon Novolizer


Budesonide 400 μg Dose


Inhalation Powder




Germany


Mylan Dura Gmbh


Budesonid Mylan


Budesonide 0,2  Mg


Inhalation Powder




Germany


Orion Corporation


Beclomet Easyhaler


Beclometasone Dipropionate 0,2  mg Dose


Inhalation Powder




Germany


Pari Pharma Gmbh


Buparid


Budesonide 0,25  mg Ampoule


Nebuliser Suspension




Germany


Pari Pharma Gmbh


Buparid


Budesonide 0,5  mg Ampoule


Nebuliser Suspension




Germany


Pari Pharma Gmbh


Buparid


Budesonide 1 mg Ampoule


Nebuliser Suspension




Germany


Pb Pharma Gmbh


Budesonid


Budesonide 0,92  Mg


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Beclometason


Beclometasone Dipropionate 100 μg Units


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Beclometason


Beclometasone Dipropionate 200 μg Units


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Beclometason


Beclometasone Dipropionate 400 μg Units


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Budesonid


Budesonide 0,8  mg Capsule


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Budesonid


Budesonide 100 μg Units


Inhalation Powder, Hard Capsule




Germany


Pb Pharma Gmbh


Cyclocaps Budesonid


Budesonide 800 μg Units


Inhalation Powder, Hard Capsule




Germany


Ratiopharm Gmbh


Beclometason Ratiopharm


Beclometasone Dipropionate 0,25  mg/18,7  g


Pressurised Inhalation, Solution




Germany


Ratiopharm Gmbh


Beclomethasone Dipropionate Ratiopharm


Beclometasone Dipropionate 0,05  mg/18,7  g


Pressurised Inhalation, Solution




Germany


Ratiopharm Gmbh


Beclomethasone Dipropionate Ratiopharm


Beclometasone Dipropionate 0,1  mg/18,7  g


Pressurised Inhalation, Solution




Germany


Ratiopharm Gmbh


Beclomethasone Dipropionate Ratiopharm


Beclometasone Dipropionate 0,2  mg/18,7  g


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Aerobec N


Beclometasone Dipropionate 100 g/5ml


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Beclometason-Ct


Beclometasone Dipropionate 0,1  Mg


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Beclometason-Ct


Beclometasone Dipropionate 0,2  Mg


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair


Beclometasone Dipropionate 100 g/10ml


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair


Beclometasone Dipropionate 100 g/18,7  g


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair


Beclometasone Dipropionate 100 g/5ml


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair


Beclometasone Dipropionate 250 g/18,7  g


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair


Beclometasone Dipropionate 250 g/78 mg


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair Mite


Beclometasone Dipropionate 50 g/18,7  g


Pressurised Inhalation, Solution




Germany


Teva Gmbh


Ventolair Mite


Beclometasone Dipropionate 50 g/78 mg


Pressurised Inhalation, Solution




Germany


Ucb Pharma Gmbh (Monheim De)


Atmadisc Forte Diskus


Fluticasone Propionate 500 μg Inhalation, Salmeterol 50 μg Inhalation


Inhalation Powder




Greece


Anfarm Hellas Sa


Talgan


Budesonide 100 μg Dose


Inhalation Powder




Greece


Astrazeneca S.A.


Pulmicort Turbuhaler


Budesonide 100 μg Dose


Inhalation Powder




Greece


Astrazeneca S.A.


Pulmicort Turbuhaler


Budesonide 200 μg Dose


Inhalation Powder




Greece


Astrazeneca S.A.


Pulmicort Turbuhaler


Budesonide 400 μg Dose


Inhalation Powder




Greece


Astrazeneca S.A.


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Greece


Astrazeneca S.A.


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Greece


Chiesi Hellas A.E.B.E.


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Greece


Chiesi Hellas A.E.B.E.


Foster Nexthaler


Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose


Inhalation Powder




Greece


Chiesi Hellas A.E.B.E.


Inuvair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Greece


Chiesi Hellas A.E.B.E.


Inuvair Nexthaler


Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose


Inhalation Powder




Greece


D.A.S.T. Biotech Pharm επε


Flihaler


Fluticasone Propionate 250mcg/Dose


Pressurised Inhalation, Suspension




Greece


Elpen Pharmaceutical Co. Inc.


Fluticapen


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Fluticapen


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Pulmoton


Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Pulmoton


Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Pulmoton


Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 125 μg Dose


Pressurised Inhalation




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Flixotide


Fluticasone Propionate 50 μg Dose


Pressurised Inhalation




Greece


Glaxosmithkline Aebe


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Greece


Glaxosmithkline Aebe


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Iasis Pharma


Olfo Haler


Budesonide 200 μg Dose


Inhalation Powder




Greece


Iasis Pharma


Olfo Haler


Budesonide 400 μg Dose


Inhalation Powder




Greece


Medicair Bioscience Laboratories S.A


Bocacort-S


Fluticasone Propionate 250mcg/Dose


Pressurised Inhalation, Suspension




Greece


Orion Corporation


Bufomix


Budosenide 160mcg, Formoterol Fumarate Dihydrate 4,5 mcg


Inhalation Powder




Greece


Orion Corporation


Bufomix


Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg


Inhalation Powder




Greece


Orion Corporation


Orest


Budosenide 160mcg, Formoterol Fumarate Dihydrate 4,5 mcg


Inhalation Powder




Greece


Orion Corporation


Orest


Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg


Inhalation Powder




Greece


Png Gerolymatos Medical A.E.


Asmaflex


Fluticasone Propionate 250mgg


Pressurised Inhalation, Suspension




Greece


Rafarm Sa.


Resata


Budesonide 200 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Rafarm Sa.


Resata


Budesonide 400 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Verisfield (Uk) Ltd


Flixocort


Fluticasone Propionate 50 μg Dose


Nasal Spray, Suspension




Greece


Verisfield (Uk) Ltd


Flixocort


Fluticasone Propionate 125 μg Dose


Pressurised Inhalation, Suspension




Greece


Verisfield (Uk) Ltd


Flixocort


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Greece


Verisfield (Uk) Ltd


Pulmihal


Budesonide 200 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Win Medica Ltd


Flusalair


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder




Greece


Win Medica Ltd


Flusalair


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Greece


Win Medica Ltd


Flutiresp


Fluticasone Propionate 250mcg/Dose


Inhalation Powder




Greece


Win Medica Ltd


Flutiresp


Fluticasone Propionate 500 μg Inhalation


Inhalation Powder




Greece


Zwitter Pharmaceuticals επε


Salenga


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Greece


Pharmanel Commercial Pharmaceutical S.A.


Vernoral


Budesonide 200 μg Dose


Inhalation Powder




Greece


Pharmanel Commercial Pharmaceutical S.A.


Vernoral


Budesonide 400 μg Dose


Inhalation Powder




Hungary


Astrazeneca Kft.


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Hungary


Astrazeneca Kft.


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Hungary


Chiesi Pharmaceuticals Gmbh


Formodual


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Hungary


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Hungary


Elpen Pharmaceutical Co. Inc.


Dimenio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder




Hungary


Elpen Pharmaceutical Co. Inc.


Dimenio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder




Hungary


Elpen Pharmaceutical Co. Inc.


Flumetor


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Hungary


Elpen Pharmaceutical Co. Inc.


Flumetor


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Hungary


Glaxosmithkline Kft.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Hungary


Montrose Kft


Thoreus Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Hungary


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Hungary


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Hungary


Sandoz Hungária Kft


Airflusol Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Iceland


Astrazeneca A-S


Symbicort Forte Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Iceland


Astrazeneca A-S


Symbicort Mite Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Iceland


Elpen Pharmaceutical Co. Inc.


Relanio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Iceland


Elpen Pharmaceutical Co. Inc.


Relanio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Iceland


Glaxosmithkline Ehf.


Flixotide


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Iceland


Glaxosmithkline Ehf.


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Iceland


Glaxosmithkline Ehf.


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Iceland


Glaxosmithkline Ehf.


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Iceland


Glaxosmithkline Ehf.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Ireland


Astrazeneca Uk Limited


Pulmicort Turbohaler


Budesonide 100 μg Dose


Inhalation Powder




Ireland


Astrazeneca Uk Limited


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Ireland


Astrazeneca Uk Limited


Pulmicort Turbohaler


Budesonide 400 μg Dose


Inhalation Powder




Ireland


Astrazeneca Uk Limited


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Ireland


Astrazeneca Uk Limited


Symbicort Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Ireland


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Ireland


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose


Inhalation Powder, Pre-Dispensed




Ireland


Glaxosmithkline (Ireland) Limited


Flixotide Diskus


Fluticasone Propionate 250 μg Blister


Inhalation Powder, Pre-Dispensed




Ireland


Glaxosmithkline (Ireland) Limited


Flixotide Diskus


Fluticasone Propionate 500 μg Blister


Inhalation Powder, Pre-Dispensed




Ireland


Glaxosmithkline (Ireland) Limited


Flixotide Evohaler


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Ireland


Glaxosmithkline (Ireland) Limited


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Ireland


Glaxosmithkline (Ireland) Limited


Viani Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Ireland


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Ireland


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Ireland


Rowex Ltd


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Ireland


Rowex Ltd


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Italy


Astrazeneca S.P.A


Sinestic


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Italy


Astrazeneca S.P.A


Sinestic


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Italy


Astrazeneca S.P.A


Symbicort


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Italy


Astrazeneca S.P.A


Symbicort


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Italy


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Glaxosmithkline S.P.A.


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Menarini International Operations Luxembourg S.A.


Aliflus Diskus


Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Menarini International Operations Luxembourg S.A.


Aliflus Diskus


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Menarini International Operations Luxembourg S.A.


Aliflus Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Italy


Promedica S.R.L.


Clenil Compositum


Beclometasone Dipropionate 0,8  mg/2 Ml, Salbutamol Sulfate 1,928  mg/2 Ml


Nebuliser Suspension




Italy


Promedica S.R.L.


Clenil Compositum


Beclometasone Dipropionate 50 μg Actuation, Salbutamol Sulfate 120 μg Actuation


Pressurised Inhalation, Solution




Italy


Simesa S.P.A.


Assieme


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Italy


Simesa S.P.A.


Assieme


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Italy


Valeas S.P.A.


Plenaer


Flunisolide 25 mg Bottle, Salbutamol 10 mg Bottle


Pressurised Inhalation, Suspension




Italy


Valeas S.P.A.


Plenaer


Salbutamol Sulfate 0,602  mg Vial, Flunisolide 0,5  mg Vial


Nebuliser Solution




Latvia


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 100 μg Dose


Inhalation Powder




Latvia


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 200 μg Dose


Inhalation Powder




Latvia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Latvia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Latvia


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Latvia


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Latvia


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Latvia


Glaxosmithkline Latvia Sia


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Latvia


Glaxosmithkline Latvia Sia


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Latvia


Glaxosmithkline Latvia Sia


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Latvia


Glaxosmithkline Latvia Sia


Flosal


Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation


Pressurised Inhalation, Suspension




Latvia


Glaxosmithkline Latvia Sia


Flosal


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder




Latvia


Glaxosmithkline Latvia Sia


Seretide


Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation


Pressurised Inhalation, Suspension




Latvia


Glaxosmithkline Latvia Sia


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder




Latvia


Novartis Finland Oy


Miflonide


Budesonide 200 μg


Inhalation Powder, Hard Capsule




Latvia


Novartis Finland Oy


Miflonide


Budesonide 400 μg


Inhalation Powder, Hard Capsule




Latvia


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Latvia


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Latvia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose


Inhalation Powder, Pre-Dispensed




Latvia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Lithuania


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Lithuania


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Lithuania


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Glaxosmithkline Lietuva Uab


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Lithuania


Glaxosmithkline Lietuva Uab


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Glaxosmithkline Lietuva Uab


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Glaxosmithkline Lietuva Uab


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Lithuania


Novartis Finland Oy


Miflonide


Budesonide 200 μg


Inhalation Powder, Hard Capsule




Lithuania


Novartis Finland Oy


Miflonide


Budesonide 400 μg


Inhalation Powder, Hard Capsule




Lithuania


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Lithuania


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg, Formoterol Fumarate Dihydrate 4,5  μg


Inhalation Powder




Lithuania


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Lithuania


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg, Formoterol Fumarate Dihydrate 9 μg


Inhalation Powder




Lithuania


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Lithuania


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Luxembourg


Chiesi Sa-Nv


Inuvair


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Luxembourg


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Luxembourg


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Flixotide


Fluticasone Propionate 50 μg Inhalation


Pressurised Inhalation, Suspension




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Luxembourg


Glaxosmithkline Pharmaceuticals S.A.


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder




Luxembourg


Nv Astrazeneca Sa


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Luxembourg


Nv Astrazeneca Sa


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Luxembourg


Nv Astrazeneca Sa


Symbicort Forte Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Luxembourg


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose


Inhalation Powder




Luxembourg


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose


Inhalation Powder




Luxembourg


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose


Inhalation Powder




Luxembourg


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose


Inhalation Powder




Malta


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 100 μg Dose


Inhalation Powder




Malta


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 200 μg Dose


Inhalation Powder




Malta


Astrazeneca Ab


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Malta


Astrazeneca Ab


Symbicort Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Malta


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Malta


Elpen Pharmaceutical Co. Inc.


Rolenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Malta


Glaxosmithkline (Ireland) Limited


Flixotide Evohaler


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Malta


Glaxosmithkline (Ireland) Limited


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Malta


Novartis Pharmaceuticals Uk Limited


Miflonide


Budesonide 200 μg Capsule


Inhalation Powder, Hard Capsule




Malta


Novartis Pharmaceuticals Uk Limited


Miflonide


Budesonide 400 μg


Inhalation Powder, Hard Capsule




Malta


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Malta


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Malta


Orion Oyj


Orest Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Malta


Orion Oyj


Orest Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Netherlands


Astrazeneca Bv


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Netherlands


Astrazeneca Bv


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Netherlands


Glaxosmithkline B.V.


Fluticasonpropionaat Inhalator GSK


Fluticasone Propionate 125 μg Dose


Aerosol




Netherlands


Glaxosmithkline B.V.


Fluticasonpropionaat Inhalator GSK


Fluticasone Propionate 250 μg Dose


Aerosol




Netherlands


Glaxosmithkline B.V.


Fluticasonpropionaat Inhalator GSK


Fluticasone Propionate 50 μg Dose


Aerosol




Netherlands


Chiesi Pharmaceuticals B.V.


Formodual


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Netherlands


Chiesi Pharmaceuticals B.V.


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Netherlands


Elpen Pharmaceutical Co. Inc.


Salmeterol/Fluticasonpropionaat Elpen


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Netherlands


Elpen Pharmaceutical Co. Inc.


Salmeterol/Fluticasonpropionaat Elpen


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Netherlands


Glaxosmithkline B.V.


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Netherlands


Glaxosmithkline B.V.


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Netherlands


Glaxosmithkline B.V.


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Norway


Astrazeneca As


Symbicort Forte Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Norway


Astrazeneca As


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Norway


Chiesi Farmaceutici S.P.A.


Inuxair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Norway


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Norway


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Norway


Glaxosmithkline As


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Norway


Sandoz A-S


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 250 μg Dose


Inhalation Powder




Norway


Sandoz A-S


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 500 μg Dose


Inhalation Powder




Poland


Adamed Sp. Z O.O.


Flutixon


Fluticasone Propionate 125 μg Capsule


Inhalation Powder, Hard Capsule




Poland


Adamed Sp. Z O.O.


Flutixon


Fluticasone Propionate 250 μg Capsule


Inhalation Powder, Hard Capsule




Poland


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 100 μg Dose


Inhalation Powder




Poland


Astrazeneca Ab


Pulmicort Turbuhaler


Budesonide 200 μg Dose


Inhalation Powder




Poland


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Poland


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Poland


Celon Pharma S.A.


Salmex


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder




Poland


Chiesi Pharmaceuticals Gmbh


Formodual


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Poland


Chiesi Pharmaceuticals Gmbh


Fostex


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Poland


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Poland


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Poland


Glaxosmithkline Export Ltd


Flixotide


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Poland


Glaxosmithkline Export Ltd


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Poland


Glaxosmithkline Export Ltd


Flixotide Dysk


Fluticasone Propionate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Poland


Glaxosmithkline Export Ltd


Seretide Dysk


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder




Poland


Meda Pharma Gmbh & Co. Kg


Budelin Novolizer


Budesonide 200 μg Dose


Inhalation Powder




Poland


Novartis Poland Sp. Z O. O.


Miflonide


Budesonide 200 μg


Inhalation Powder, Hard Capsule




Poland


Novartis Poland Sp. Z O. O.


Miflonide


Budesonide 400 μg


Inhalation Powder, Hard Capsule




Poland


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Poland


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Poland


Polfarmex S.A.


Asaris


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder




Poland


Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O.


Budezonid Lek-Am


Budesonide 200 μg Inhalation


Inhalation Powder, Hard Capsule




Poland


Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O.


Budezonid Lek-Am


Budesonide 400 μg Inhalation


Inhalation Powder, Hard Capsule




Portugal


Astrazeneca Produtos Farmacêuticos, Lda.


Assieme Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Portugal


Astrazeneca Produtos Farmacêuticos, Lda.


Assieme Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Portugal


Astrazeneca Produtos Farmaceuticos Limitada


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Portugal


Astrazeneca Produtos Farmaceuticos Limitada


Pulmicort Turbohaler


Budesonide 400 μg Dose


Inhalation Powder




Portugal


Astrazeneca Produtos Farmacêuticos, Lda.


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Portugal


Astrazeneca Produtos Farmacêuticos, Lda.


Symbicort Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Portugal


Bialfar — Produtos Farmacêuticos, Sociedade Anónima


Brisomax Diskus


Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Bialfar — Produtos Farmacêuticos, Sociedade Anónima


Brisomax Diskus


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Bialfar — Produtos Farmacêuticos, Sociedade Anónima


Brisomax Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.


Budesonida Farmoz


Budesonide 200 μg Dose


Inhalation Powder




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.


Budesonida Farmoz


Budesonide 400 μg Dose


Inhalation Powder




Portugal


Glaxo Wellcome Farmacêutica, Limitada


Seretaide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Glaxosmithkline — Produtos Farmacêuticos, Limitada


Maizar Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Portugal


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Portugal


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Portugal


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Portugal


Pentafarma — Sociedade Tecnico-Medicinal S.A.


Budesonida Tecnicort


Budesonide 200 μg Dose


Inhalation Powder




Portugal


Pentafarma — Sociedade Tecnico-Medicinal S.A.


Budesonida Tecnicort


Budesonide 400 μg Dose


Inhalation Powder




Portugal


Sandoz Farmacêutica, Limitada


Airflusal Forspiro


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Portugal


Sandoz Farmacêutica, Limitada


Airflusal Forspiro


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Romania


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Romania


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Romania


Chiesi Pharmaceuticals Gmbh


Foster


Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation


Pressurised Inhalation, Solution




Romania


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Romania


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Romania


Glaxo Wellcome Ltd


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Romania


Glaxo Wellcome Ltd


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Romania


Glaxo Wellcome Ltd


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Romania


Glaxo Wellcome Ltd


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Romania


Medochemie Romania S.R.L.


Frenolyn


Budesonide, Micronised 200 μg Dose


Inhalation Powder




Romania


Medochemie Romania S.R.L.


Frenolyn


Budesonide, Micronised 400 μg Dose


Inhalation Powder




Romania


Orion Oyj


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Romania


Orion Oyj


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Romania


S.C. Sandoz S.R.L.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Slovakia


Astrazeneca Ab


Pulmicort Turbohaler


Budesonide 100 μg Dose


Inhalation Powder




Slovakia


Astrazeneca Ab


Pulmicort Turbohaler


Budesonide 200 μg Dose


Inhalation Powder




Slovakia


Astrazeneca Ab


Pulmicort Turbohaler


Budesonide 400 μg Dose


Inhalation Powder




Slovakia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Slovakia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Slovakia


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Slovakia


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovakia


Elpen Pharmaceutical Co. Inc.


Dimenium


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovakia


Elpen Pharmaceutical Co. Inc.


Flumetor


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovakia


Elpen Pharmaceutical Co. Inc.


Flumetor


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovakia


Glaxo Group Limited


Flixotide


Fluticasone Propionate 125 μg Inhalation


Pressurised Inhalation, Suspension




Slovakia


Glaxo Group Limited


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Slovakia


Glaxo Group Limited


Flixotide


Fluticasone Propionate 50 μg Inhalation


Pressurised Inhalation, Suspension




Slovakia


Glaxo Group Limited


Seretide


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovakia


Glaxosmithkline Slovakia S.R.O.


Flixotide Diskus


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Slovakia


Glaxosmithkline Slovakia S.R.O.


Flixotide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Slovakia


Glaxosmithkline Slovakia S.R.O.


Flixotide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Slovakia


Glaxosmithkline Slovakia S.R.O.


Flixotide Diskus


Fluticasone Propionate 50 μg Dose


Inhalation Powder




Slovakia


Meda Pharma Spol. S R.O.


Budelin Novolizer


Budesonide 200 μg Dose


Inhalation Powder




Slovakia


Novartis, S.R.O.


Miflonid


Budesonide 200 μg


Inhalation Powder, Hard Capsule




Slovakia


Novartis, S.R.O.


Miflonid


Budesonide 400 μg


Inhalation Powder, Hard Capsule




Slovakia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Slovakia


Sandoz Pharmaceuticals D.D.


Airflusal Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Slovenia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Slovenia


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Slovenia


Chiesi Pharmaceuticals Gmbh


Formodual


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Slovenia


Chiesi Pharmaceuticals Gmbh


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Slovenia


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovenia


Elpen Pharmaceutical Co. Inc.


Flamerio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovenia


Glaxosmithkline D.O.O., Ljubljana


Flixotide


Fluticasone Propionate 250 μg Spray


Pressurised Inhalation, Suspension




Slovenia


Glaxosmithkline D.O.O., Ljubljana


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Slovenia


Lek Pharmaceuticals D.D. Ljubljana


Airflusan Forspiro


Salmeterol 50 μg Dose, Fluticasone Propionate 500 μg Dose


Inhalation Powder




Slovenia


Meda Pharma Gmbh & Co. Kg


Budelin Novolizer


Budesonide 200 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Allen Farmaceutica, S.A.


Anasma Accuhaler


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 50 μg Dose, Salmeterol Xinafoate 25 μg Dose


Pressurised Inhalation, Suspension




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 25 μg Dose


Pressurised Inhalation, Suspension




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 125 μg Dose, Salmeterol Xinafoate 25 μg Dose


Pressurised Inhalation, Suspension




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Almirall, S.A.


Plusvent


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Astrazeneca Farmacéutica Spain, S.A.


Pulmicort Turbuhaler


Budesonide 100 μg Dose


Inhalation Powder




Spain


Astrazeneca Farmacéutica Spain, S.A.


Pulmicort Turbuhaler


Budesonide 200 μg Dose


Inhalation Powder




Spain


Astrazeneca Farmacéutica Spain, S.A.


Pulmicort Turbuhaler


Budesonide 400 μg Dose


Inhalation Powder




Spain


Astrazeneca Farmacéutica Spain, S.A.


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Spain


Astrazeneca Farmacéutica Spain, S.A.


Symbicort Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Spain


Chiesi España, S.A.


Formodual


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Spain


Chiesi España, S.A.


Foster


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Dose


Pressurised Inhalation, Solution




Spain


Glaxosmithkline S.A.


Brisair Accuhaler


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Glaxosmithkline S.A.


Brisair Accuhaler


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Glaxosmithkline S.A.


Flixotide


Fluticasone Propionate 125 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Flixotide


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Flixotide


Fluticasone Propionate 50 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Flixotide Accuhaler


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Flixotide Accuhaler


Fluticasone Propionate 250 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Flixotide Accuhaler


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Flusonal


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Flusonal


Fluticasone Propionate 50 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Flusonal Accuhaler


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Flusonal Accuhaler


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Inalacor


Fluticasone Propionate 250 μg Inhalation


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Inalacor


Fluticasone Propionate 50 μg Dose


Pressurised Inhalation, Suspension




Spain


Glaxosmithkline S.A.


Inalacor Accuhaler


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Inalacor Accuhaler


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Spain


Glaxosmithkline S.A.


Inaladuo Accuhaler


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Glaxosmithkline S.A.


Seretide Accuhaler


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Spain


Laboratorio Tau, S.A.


Rilast Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Spain


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Spain


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Spain


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Spain


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Spain


Smithkline Beecham Farma S.A.


Trialona


Fluticasone Propionate 250 μg Dose


Pressurised Inhalation, Suspension




Spain


Smithkline Beecham Farma S.A.


Trialona


Fluticasone Propionate 50 μg Dose


Pressurised Inhalation, Suspension




Spain


Smithkline Beecham Farma S.A.


Trialona Accuhaler


Fluticasone Propionate 100 μg Dose


Inhalation Powder




Spain


Smithkline Beecham Farma S.A.


Trialona Accuhaler


Fluticasone Propionate 500 μg Dose


Inhalation Powder




Sweden


Astrazeneca Ab


Gardette


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Sweden


Astrazeneca Ab


Gardette Forte


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Sweden


Astrazeneca Ab


Symbicort Forte Turbuhaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




Sweden


Astrazeneca Ab


Symbicort Turbuhaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




Sweden


Chiesi Farmaceutici S.P.A.


Innovair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




Sweden


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Flusamer


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Flusaterol


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Flusaterol


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Relanio


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Relanio


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Elpen Pharmaceutical Co. Inc.


Salmeson


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Glaxosmithkline Ab


Flutide Diskus


Fluticasone Propionate 250 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Glaxosmithkline Ab


Flutide Diskus


Fluticasone Propionate 500 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Glaxosmithkline Ab


Seretide Diskus


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Glaxosmithkline Ab


Viani Diskus Forte


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Hexal Ag


Salmeterol/Fluticasone Hexal


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Sweden


Orion Corporation


Bufomix Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Sweden


Orion Corporation


Bufomix Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Sweden


Orion Corporation


Orest Easyhaler


Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation


Inhalation Powder




Sweden


Orion Corporation


Orest Easyhaler


Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation


Inhalation Powder




Sweden


Sandoz A-S


Aesalfluca Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Airflusal Forspiro


Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Sandoz A-S


Airflusal Forspiro


Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose


Inhalation Powder, Pre-Dispensed




Sweden


Sandoz A-S


Flaxxone Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Flaxxone Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Lastenol Forspiro


Fluticasone Propionate 500 Microgram, Salmeterol Xinafoate 50 Microgram


Inhalation Powder




Sweden


Sandoz A-S


Molduo Forspiro


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Salmetorol/Fluticasone Sandoz


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Setirenol


Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose


Inhalation Powder




Sweden


Sandoz A-S


Setirenol


Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose


Inhalation Powder




United Kingdom


Astrazeneca Uk Limited


Symbicort Turbohaler


Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose


Inhalation Powder




United Kingdom


Astrazeneca Uk Limited


Symbicort Turbohaler


Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose


Inhalation Powder




United Kingdom


Chiesi Limited


Formodual


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




United Kingdom


Chiesi Limited


Fostair


Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation


Pressurised Inhalation, Solution




United Kingdom


Glaxo Wellcome Ltd


Seretide


Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




United Kingdom


Glaxo Wellcome Ltd


Seretide


Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed




United Kingdom


Glaxo Wellcome Ltd


Seretide Accuhaler


Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose


Inhalation Powder, Pre-Dispensed







ANNEX II
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States











Member State EU/EEA


Applicant/marketing authorisation holder


Name


Strength


Pharmaceutical form


Animal species


Route of administration




Belgium


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Bulgaria


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Croatia


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




France


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Germany


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Ireland


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Italy


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




The Netherlands


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Poland


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Portugal


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Romania


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Slovenia


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




Spain


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use




United Kingdom


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


CattleMarker IBR Inactivated emulsion for injection for cattle


Each 2 ml dose contains:
Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5  log2



Emulsion for injection


Cattle


Subcutaneous use







ANNEX III
List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States











Member State in EEA


Marketing authorisation holder


Invented name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Cyprus


MEDA Pharmaceuticals S.A.
3, Evritanias Str.
GR-15231
Chalandri-Attiki
Greece


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Finland


MEDA Oy
Vaisalantie 4
FIN-02130
Espoo
Finland


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Finland


MEDA Oy
Vaisalantie 4
FIN-02130
Espoo
Finland


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml




France


MEDA Pharma S.A.S.
25, Boulevard de l'Amiral Bruix
F-75016
Paris
France


Novantrone 10 mg/5 ml, solution à diluer pour perfusion


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




France


MEDA Pharma S.A.S.
25, Boulevard de l'Amiral Bruix
F-75016
Paris
France


Novantrone 20 mg/10 ml, solution à diluer pour perfusion


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




France


MEDA Pharma S.A.S.
25, Boulevard de l'Amiral Bruix
F-75016
Paris
France


Elsep 2 mg/ml, solution à diluer pour perfusion


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Germany


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Novantron 10 mg/5 ml


2 mg/ml


Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use


Intravenous use Intrapleural use
Intraperitoneal use


10 mg/5 ml




Germany


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Novantron 20 mg/10 ml


2 mg/ml


Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use


Intravenous use Intrapleural use
Intraperitoneal use


20 mg/10 ml




Germany


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Ralenova 2 mg/ml


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Germany


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Ralenova 2 mg/ml


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml




Greece


MEDA Pharmaceuticals S.A.
3, Evritanias Str.
GR-15231
Chalandri-Attiki
Greece


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Iceland


MEDA AB
Pipers vag 2A, Box 906
SE-170 09
Solna
Sweden


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Iceland


MEDA AB
Pipers vag 2A, Box 906
SE-170 09
Solna
Sweden


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml




Italy


MEDA Pharma S.p.A.
Viale Brenta 18
IT-20139
Milano
Italy


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml




Italy


MEDA Pharma S.p.A.
Viale Brenta 18
IT-20139
Milano
Italy


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Norway


MEDA A/S
Askerveien 61
NO-1384
Asker
Norway


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml




Romania


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Slovenia


MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany


Novantrone


2 mg/ml


Concentrate for solution for injection/infusion


Intravenous use


20 mg/10 ml




Spain


MEDA Pharma S.A.U.
Edificio Berlin — Parque Empresarial San Fernando, Avda Castilla 2, 2a planta
E-28830
SAN FERNANDO DE HENARES (MADRID)
Spain


Novantrone 20 mg solución inyectable


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Sweden


MEDA AB
Pipers vag 2A, Box 906
SE-170 09
Solna
Sweden


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


20 mg/10 ml




Sweden


MEDA AB
Pipers vag 2A, Box 906
SE-170 09
Solna
Sweden


Novantrone


2 mg/ml


Concentrate for solution for infusion


Intravenous use


10 mg/5 ml