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List of nationally authorised medicinal products for human use

ambroxol or bromhexine

Product name: ambroxol or bromhexine
Also marketed in the EU under the name(s): Abrobion, Aflegan, Afrodor, Ambex, Ambixol, Amboral, Ambrex, Ambrin, Ambro, Ambro-AbZ, Ambro-CT, Ambro-Hemopharm Hustensaft, Ambro-ratiopharm, Ambrobene, Ambrobeta, Ambrobeta Saft, Ambrohexal, AMBROinfant, Ambroksol, Ambroksolijev klorid Berlin-Chemie, Ambroksols Stirol, Ambrolan, Ambrolex R, Ambrosan, Ambrosan kapky, Ambrosol Teva, Ambrosolvan, Ambrospray, Ambrotaxer, Ambrotus, Ambrox-Denk, Ambroxhexal, Ambroxin-Tropfen, Ambroxine, Ambroxo Brause, Ambroxo Hermes, Ambroxol, Ambroxolhydrochloride Cyathus, Ambroxoli hydrochloridum Fontane, Ambroxolo, Amdox-Puren, Amobronc, Anavix, Aprinol, Axol, Bactopumon, Balsoprim suspensiˇn, Basiflux, Benflux, Bisolangin, Bisolaryn gegen Halzschmerzen, Bisolex, Bisolmed, BISOLVOMYCINE, Bisolvon, Braxol, Bromax, Bromexina, BROMFLUEX, Bromhex, Bromhexin, Bromhexine, Bromocal, Bron-Hal, Bronchi-Mereprine, Broncho-Euphyllin retard, BRONCHOSAN, Bronchotussine, Broncoliber, Broncolyn, Broncosil, BRONHOSOLV, Bronquidiazina CR suspensiˇn, Brontex, Bronxol, Broomhexine HCI, Broomhexinehydrochloride, Broxol, Brufix, Bunafon, C1000 Hoestdrank Broomhexine HCl, Celibron, Clamoxyl mucolÝtico, Deflegmin, Dinobroxol jarabe, Doxam, Doxy, Drenoxol, Ebertuss, Entus Junior, Entus Max, Envil kaszel, Expit, Flavamed, Flecoxin, Flegamina, Flegatussin, Fluibron, Fluibrox, Fluidrenol, Flutoxil, Formulamucol, Gammaxol, Gogolox, Grenovix, Grippostad Ambro, Halixol, HEMA Hoestdrank Broomhexine HCl, Hoestdrank Broomhexine HCl, Hoesttabletten Broomhexine HCl, Hyvotex, IDYL Hoestdrank Broomhexine HCl, IDYL hoesttabletten, JUMBO Hoestdrank Broomhexine HCl, JUMBO hoesttabletten broomhexine HCl, Kriolen, Kruidvat HOESTDRANK Broomhexine HCl, Lactucol, Lasolvan, Leidapharm Hoestdrank Broomhexine HCl, Lindoxyl K, Lintos, Lisomucin, Lizipadol, Lysopadol, LYSOPA¤NE MAUX DE GORGE AMBROXOL, MEDIPEKT, Medovent, MEDOX, Mollipect, Motosol, Mucibron, Muciclar, Mucoangin, Mucoangine, Mucoaricodil, Mucobroxol, Mucodrenol, MUCOFREE, Mucolin, Mucolisin, Mucosan, Mucosin, Mucosolvan, Mucospas, Mucotosse, MUCOVIN, Mucovix, Mukambro, Muxol, NASOPAX, Naxpa jarabe, NEDAC SORBO, Neo-bronchol, Nibren, Nirolex tosse e catarro, Otrivin Broomhexine HCI, Paxirasol, Physiosolvan, Pro-Ambrosan, Provixen-N, Pńdiamuc Saft, Rexambro, ROMHEXIN SLAVIA, Saribal, Secretil, Sigamuc, Solvolan, Spasmo-Mucosolvan, Spectorum Expectorante, Stefolant, Stopex na vykaÜliavanie, STREPSILS EXPECTORANT, Strubelin, Surbronc, Surfactal, Tauglicolo, Tauxolo, Tevoril, Tosse, Tosseque, Toularynx Bromhexine, Trekpleister HOESTDRANK Broomhexine HCl, Trekpleister hoesttabletten, Tusmed, Tussal Expectorans, Tussefar, Tussisol, Ventibron, Ventoliber, VICKS EXPECTORANT AMBROXOL, Vicks Hoestdrank broomhexinehydrochloride, Vicks tosse mucolitico, Viscomucil, Wick Hustenl÷ser Therapie, Wick Schleiml÷ser, Zerinol Gola
Active substance: ambroxol and bromhexine
Indication: • secretolytic (mucolytic) agent: decreasing mucus viscosity through depolymerisation of acidic polysaccharide fibres in the bronchial secretion and stimulation of neutral polysaccharide production by glandular cells
• mucokinetic agent: stimulation of cilia activity and mucociliary clearance (MCC)
• enhancement of availability of surfactant (through its stimulating effect on the synthesis and release of surfactant by type II pneumocytes)
• antioxidant actions
• anti-inflammatory actions
• anti-viral and anti-bacterial properties
• local anaesthetic (through inhibition of the neuronal sodium channels)
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/01/2016 Referral EMEA/H/A/-31/1397 (2016)226 of 14/01/2016