natgillin/translations-raw huggingface dataset:
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor 
dysfázia, neurologická porucha (NOS), neuropatia, periférna neuropatia, parestézia, porucha reči, tras
Themedian times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03). 
Mediány časov do progresie nádoru podľa týchto cieľov boli u TMZ dlhšie v rozsahu 0,7 až 2,1
Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain 
porucha zraku, výpadok v zornom poli, bolesť oka znížená zraková ostrosť, bolesť oka, suché oči
Temozolomide Teva 250 mg hard capsules Temozolomide 
Temozolomide Teva 250 mg tvrdé kapsuly Temozolomid
Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days). 
Pacienti v ramene TMZ + RT súbežne dostávali TMZ (75 mg/ m²) raz denne,
Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms. 
2, n=70), v ktorej bolo celkové prežívanie a čas do progresie podobné v oboch ramenách.
absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting). 
Súbežná liečba s TMZ môže pokračovať, keď sú splnené všetky nasledovné podmienky: absolútny počet neutrofilov ≥ 1,5 x 109/l, počet trombocytov ≥ 100 x 109/l, CTC nehematologickej toxicity ≤
Indigo carmine (E132) aluminium lake 
hlinitý lak indigokarmínu (E132)
Impotence 
únava
Temozolomide Teva 180 mg hard capsules 
Temozolomide Teva 180 mg tvrdé kapsuly
Excipient with known effect Each hard capsule contains 87 mg of lactose. 
Každá tvrdá kapsula obsahuje 87 mg laktózy.
Temozolomide Teva 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body 
Temozolomide Teva 180 mg dva pásiky na vrchnáčiku a “T 180 mg” na tele vytlačené červeným atramentom
Febril neutropenia, thrombocytopenia, anaemia, leukopenia 
neutropénia, trombocytopénia, lymfopénia, leukopénia febrilná neutropénia, trombocytopénia, anémia, leukopénia
Sodium starch glycolate Type A Colloidal anhydrous silica Tartaric acid 
Obsah kapsuly laktóza sodná soľ karboxymetylškrobu typu A koloidný oxid kremičitý kyselina vínna kyselina stearová
Temozolomide Teva 100 mg two stripes in pink ink on the cap and “T 100 mg” in pink ink on the body 
Temozolomide Teva 100 mg dva pásiky na vrchnáčiku a “T 100 mg” na tele vytlačené ružovým atramentom
Temozolomide Teva 100 mg hard capsules 
Temozolomide Teva 100 mg tvrdé kapsuly
Temozolomide Teva contains sunset yellow FCF (E110) 
hlinitý lak oranžovej žlti FCF (E110)
Temozolomide Teva 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body 
Teva 20 mg dva pásiky na vrchnáčiku a “T 20 mg” na tele vytlačené oranžovým atramentom
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8% of female vs 4% of male subjects and Grade 4 thrombocytopenia in 8% of female vs 3% of male subjects in the first cycle of therapy. 
stupňa u 3 % žien v porovnaní s 0 % mužov a trombocytopénia 4. stupňa u 1
Therefore, special care should be taken when TMZ is administered in elderly patients. 
Preto sa má starším pacientom venovať zvláštna starostlivosť, ak sa im podáva
Excipient with known effect Each hard capsule contains 84 mg of lactose. 
Každá tvrdá kapsula obsahuje 84 mg laktózy.
Temozolomide Teva 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body. 
Temozolomide Teva 250 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma čiernymi pásikmi.
Temozolomide Teva 250 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), Ammonium hydroxide (E527). 
Temozolomide Teva 250 mg tvrdé kaspuly (vrátane potlače): želatína, oxid titaničitý (E171), šelak,
TMZ is to be discontinued if: dose level -1 (100 mg/m²) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. 
• sa po znížení dávky objaví rovnaká nehematologická toxicita 3. stupňa (okrem alopécie, nevoľnosti a vracania).
Propylene Glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 
propylénglykol, hlinitý lak indigokarmínu (E132), žltý oxid železitý (E172)
Temozolomide Teva 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body. 
Temozolomide Teva 5 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma zelenými pásikmi.
Temozolomide Teva 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body. 
Temozolomide Teva 140 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma modrými pásikmi.
Temozolomide Teva 140 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake Temozolomide Teva 180 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, red iron oxide (E172) 
Temozolomide Teva 100 mg tvrdé kaspuly (vrátane potlače): želatína, oxid titaničitý (E171), červený oxid železitý (E172), šelak, propylénglykol a žltý oxid železitý (E172)
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
ALEBO OBMEDZENIA TÝKAJÚCE SA VÝDAJA REGISTRÁCIE
Temozolomide Teva monotherapy in recurrent or progressive glioma The following side effects may occur, and may require medical attention. 
Temozolomide Teva v monoterapii pri opakujúcom sa alebo postupujúcom glióme
Contains lactose, sunset yellow FCF (E110). 
Obsahuje laktózu, hlinitý lak oranžovej žlti (E110).
Temozolomide Teva contains lactose 
Teva obsahuje laktózu
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry 
zápcha, nauzea, vracanie zápcha, nauzea, vracanie
Strength 
únava.
Excipient with known effect Each hard capsule contains 150 mg of lactose. 
Každá tvrdá kapsula obsahuje 150 mg laktózy.
Common (may affect up to 1 in 10 people): loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste. 
skrátenie dychu, hnačka, bolesť brucha, žalúdočná nevoľnosť, vyrážka, svrbenie, strata vlasov, horúčka, slabosť, tras, pocit slabosti, bolesť, zmena chuti.
Temozolomide Teva 20 mg hard capsules Temozolomide 
Teva 20 mg tvrdé kapsuly Temozolomid
Temozolomide Teva 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body. 
Teva 20 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma oranžovými pásikmi.
CTC Non-haematological Toxicity (except for alopecia, nausea, vomiting) 
1.stupeň (okrem alopécie, nevoľnosti a vracania).
Stearic acid 
Cytotoxické lézie,
In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration. 
pozorovala u pacientov dostávajúcich TMZ v kombinácii s rádioterapiou vrátane prípadov súbežného podávania steroidov.
EU/1/09/606/011 5 capsules EU/1/09/606/012 20 capsules 
5 kapsúl EU/1/09/606/012 20 kapsúl
absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder. 
zhoršenie stavu, zimnica, zmena farby jazyka, porucha čuchu, smäd asténie, opuch tváre, bolesť,
Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation 
Časté (môžu postihovať menej ako 1 z 10 osôb): zníženie hmotnosti, únava, závrat, pocit brnenia,
See package leaflet for further information. 
Pre ďalšie informácie pozri písomnú informáciu pre používateľa.
Temozolomide Teva 180 mg hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body. 
Temozolomide Teva 180 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma červenými pásikmi.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively. 
V závislosti od AUC TMZ je expozícia MTIC ~
Temozolomide Teva 20 mg 
Teva 20 mg
Each hard capsule contains 100 mg temozolomide 
Každá tvrdá kapsula obsahuje 100 mg temozolomidu.
Fever, asthenia, rigors, malaise, pain, taste perversion 
horúčka, asténia, zimnica, nevoľnosť, bolesť,
Temozolomide Teva 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body. 
Temozolomide Teva 100 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma ružovými pásikmi.
The hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body. 
Tvrdé kapsuly majú nepriehľadné biele telo a vrchnáčik s dvoma čiernymi pásikmi.
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19% and 17% respectively, of patients treated for malignant glioma. 
17 % pacientov liečených na malígny glióm.
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain 
amenorea, vaginitída, bolesť prsníka
The hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body. 
Tvrdé kapsuly majú nepriehľadné biele telo a vrchnáčik s dvoma oranžovými pásikmi.
Nervous system disorders Very Common: 
Poruchy nervového systému
Micturition frequency, urinary incontinence 
zvýšené močenie, inkontinencia moču inkontinencia moču
Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance 
hypoestézia, neurologická porucha (NOS), periférna neuropatia hemiplégia, ataxia, nezvyčajná koordinácia, nezvyčajná chôdza,
The hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body. 
Tvrdé kapsuly majú nepriehľadné biele telo a vrchnáčik s dvoma zelenými pásikmi.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment. 
Vzhľadom na farmakokinetické vlastnosti TMZ nie je pravdepodobné,
EU/1/09/606/003 5 capsules EU/1/09/606/004 20 capsules 
5 kapsúl EU/1/09/606/004 20 kapsúl
diabetes insipidus 
Psychické poruchy
EU/1/09/606/001 5 capsules EU/1/09/606/002 20 capsules 
5 kapsúl EU/1/09/606/002 20 kapsúl
nausea and vomiting). 
Infekcie a nákazy*
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor 
parestézia, porucha reči, tras hemiparéza, afázia, porucha rovnováhy, somnolencia,
EU/1/09/606/005 5 capsules EU/1/09/606/006 20 capsules 
5 kapsúl EU/1/09/606/006 20 kapsúl
Asthenia, flushing, hot flushes, 
asténia, sčervenenie, návaly tepla,
EU/1/09/606/009 5 capsules EU/1/09/606/010 20 capsules 
5 kapsúl EU/1/09/606/010 20 kapsúl
EU/1/09/606/007 5 capsules EU/1/09/606/008 20 capsules 
5 kapsúl EU/1/09/606/008 20 kapsúl
Constipation, nausea, vomiting 
zhoršenie stavu, zimnica, porucha zuba
ul. 
TMZ.
Titanium dioxide (E171) Yellow iron oxide (E172) Indigo carmine (E132) aluminium lake 
propylénglykol, hlinitý lak indigokarmínu (E132)
EU/2/00/018/001 Incurin 1 mg Tablet 
EU/2/00/018/001
Box containing 1 blister 
Škatuľka s 1 blistrom
EU Number Name Strength Pharmaceutical form 
Referenčné číslo v EÚ
Oral use 
Spôsob podávania
EU/1/96/018/001 Rapilysin 
EU/1/96/018/001
10 U 10 ml (1 U/ml) 
U 10 ml (1
2 prefilled syringes 2 reconstitution devices and 2 needles 19 G l 
2 rekonštitučné pomôcky a 2 ihly 19 G l
Powder: vial (glass) Solvent: prefilled syringe (glass) 
Rozpúšťadlo: naplnená injekčná striekačka (sklo)
10 U Powder and solvent for solution for injection 
U Prášok a rozpúšťadlo na injekčný roztok
2 vials 
Rapilysin
Luxembourg Qualiphar Laboratoire Rijksweg 9 
Luxembursko Qualiphar Laboratoire Rijksweg 9
Farma 1000 - Prod. 
Portugalsko Farma 1000 - Prod.
Str. Cuza-Vodă nr. 99-105, Târgu Mureş, 
Cuza-Vodă nr. 99-105, Târgu Mureş,
Luxembourg Hexal AG Industriestr. 
Luxembursko Hexal AG Industriestr.
2700-327 Amadora Portugal 
2700-327 Amadora
Luxembourg D.J.VAN TINTELEN BEHEER B.V. 
Luxembursko D.J.VAN TINTELEN BEHEER B.V.
Finland Oy Leiras Takeda Paciuksenkatu 21 
Oy Leiras Takeda Paciuksenkatu 21
Nedac Sorbo B.V. Innovatie 1 
Holandsko Nedac Sorbo B.V. Innovatie 1
Marathonos 95, 19009 Pikermi, 
Marathonos 95, 19009
Luxembourg Biocodex Avenue Gallieni 7 
Luxembursko Biocodex Avenue Gallieni 7
2070-012 Cartaxo Portugal 
2070-012 Cartaxo
Lamiaco-Lejona Vizcaya Spain 
Lamiaco-Lejona Vizcaya
& Emp F/Kon-Chem/Kon & Kal. 
& Emp F/Kon-Chem/Kon
Avenida Professor Doutor Cavaco Silva, 10ETaguspark 
Avenida Professor Doutor Cavaco Silva, 10E
Genepharm Ae, 18 Km. 
Ae, 18 Km.
Hlohovec 920 27 Slovak Republic bromhexine hydrochloride, mentholum, oleum foeniculi, oleum anisi, oleum origani, oleum menthae piperitae, oleum eucalypti 
Hlohovec 920 27 Slovak Republic bromhexíniumchlorid, mentholum, oleum foeniculi, oleum anisi, oleum origani, oleum menthae piperitae, oleum eucalypti
Romania VIM SPECTRUM SRL, ROMANIA 
Rumunsko VIM SPECTRUM SRL, ROMANIA
CHRIS PHARMAZEUTISCHE HANDELSGESELLSCHAFT mbH 
Francúzsko CHRIS PHARMAZEUTISCHE HANDELSGESELLSCHAFT mbH
Varnavas Hadjipanayis Ltd Yiannou Kranidioti Avenue 226 Latsia / Lefkosia 
Ltd Yiannou Kranidioti Avenue 226 Latsia / Lefkosia
Romania ROMPHARM COMPANY SRL, Str. Eroilor, 1A, Otopeni, Romania 
Rumunsko ROMPHARM COMPANY SRL, Str. Eroilor, 1A, Otopeni, Romania
ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon 
Francúzsko ARROW GENERIQUES 26, avenue Tony Garnier 69007
Romania LAROPHARM SRL, Sos. 
Rumunsko LAROPHARM SRL, Sos.
Romania GEDEON RICHTER ROMÂNIA S.A., ROMANIA 
Rumunsko GEDEON RICHTER ROMÂNIA S.A.,
ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2, Bucureşti, cod postal 024022, 
Str. Ştefan Mihăileanu nr. 31, Sector 2, Bucureşti, cod postal 024022,
Romania ANTIBIOTICE SA Str. Valea Lupului nr.1, Iasi 707410, 
Valea Lupului nr.1, Iasi 707410,
Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A. 
Portugalsko Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
Bluepharma GenéricosComércio de Medicamentos, S.A. 
Portugalsko Bluepharma GenéricosComércio de Medicamentos, S.A.
Romania Egis Pharmaceuticals Plc Kereszturi ut 30-38 
Rumunsko Egis Pharmaceuticals Plc Kereszturi ut 30-38
Romania SOLACIUM PHARMA S.R.L., str. Calea Rahovei nr. 266268, corp. 60, axele A-B, stalpii 11-16, etaj II, birou 1, sector 5, Bucuresti 
Calea Rahovei nr. 266268, corp. 60, axele A-B, stalpii 11-16, etaj II, birou 1, sector 5, Bucuresti
Laboratoires de l'AEROCID 248 bis, rue Gabriel Péri B.P. 
Francúzsko Laboratoires de l'AEROCID 248 bis, rue Gabriel Péri B.P. 126
Viale G. Ribotta, 11 00144 Roma Italy 
Viale G. Ribotta, 11 00144
821 02 Bratislava Slovak Republic 
821 02 Bratislava Slovak
HTP Huisapotheek B.V. Nieuwe Donk 3 
Holandsko HTP Huisapotheek B.V. Nieuwe Donk 3
Ostrobramska 91 04-118 Warszawa Poland 
ul. Ostrobramska 91 04-118 Warszawa Poland
REMEDICA LTD Aharnon street P.O.Box 51706 
LTD Aharnon street P.O.Box 51706
Herbapol - Lublin S.A. ul. 
Herbapol - Lublin S.A.
Via Nocera Umbra, 75 00181 Roma Italy 
Via Nocera Umbra, 75 00181
851 01, Bratislava Slovak Republic 
851 01, Bratislava Slovak
Basic Pharma Manufacturing bv 
Holandsko Basic Pharma Manufacturing bv
Procter & Gamble Nederland B.V. 
& Gamble Nederland B.V.
WALMARK, a.s. Oldřichovice 44 739 61 Třinec Czech Republic 
Oldřichovice 44 739 61 Třinec
4 mg + 3,86 mg solution for injection injection use 
4 mg + 3,86 mg injekčný roztok injekčné použitie
Caldeira & Metelo, Lda. 
& Metelo, Lda.
APOTEX EUROPE B.V: Darwinweg, 20 
EUROPE B.V: Darwinweg, 20
Via Beato Sebastiano Valfre 4, 10121 Torino Italy 
Via Beato Sebastiano Valfre 4, 10121
Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide 
Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012
Via Vittor Pisani, 20 20124 Milano Italy 
Via Vittor Pisani, 20 20124
Emilii Plater 53 00-113 Warszawa Poland 
ul. Emilii Plater 53 00-113 Warszawa
Romania S.C. 
Rumunsko S.C.
Pliva Hrvatska d.o.o. 
Chorvátsko Pliva Hrvatska d.o.o.
Via Messina, 38 20154 Milano Italy 
Via Messina, 38 20154
Przemysłowa 2 35-959 Rzeszów Poland 
ul. Przemysłowa 2 35-959
Unilfarma - União Internacional Laboratórios Farmacêuticos, Lda. 
Portugalsko Unilfarma - União Internacional Laboratórios Farmacêuticos, Lda.
Rua Aquilino Ribeiro, 6-A 2790-027 Carnaxide Portugal 
Rua Aquilino Ribeiro, 6-A 2790-027 Carnaxide Portugal ambroxol
LABORATORIOS NORMON S.A. 
Španielsko LABORATORIOS NORMON S.A.
FERRER INTERNACIONAL S.A. 
Španielsko FERRER INTERNACIONAL S.A.
Bromhexine hydrochloride Extractum fluidum aquosum ex Plantaginis lanceolatae folii et Verbasci floribus 
Lublin Poland bromhexíniumchlorid Extractum fluidum aquosum ex Plantaginis lanceolatae folii et Verbasci floribus
1-10 Constantinoupoleos Street, 3011, P.O. 
Street, 3011, P.O.
Distrifarma - Companhia de Distribuição Farmacêutica, S.A. 
Portugalsko Distrifarma - Companhia de Distribuição Farmacêutica, S.A.
Broxol Adulti granules 
Broxol Adulti granulát
G. L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, 
G. L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert Schweitzergasse 3 Vienna 
Arzneimittel Vertriebs-GmbH Albert Schweitzergasse 3 Vienna
8 mg + 500 mg capsule, hard 
8 mg + 500 mg tvrdá kapsula
Via Cavriana, 14 20134 Milano Italy 
Via Cavriana, 14 20134
Via Cesarea, 11/10 16121 Genova Italy 
Via Cesarea, 11/10 16121
Mucosan 60 mg polvo para solución oral powder for oral suspension 
Mucosan 60 mg polvo para solución oral prášok na perorálnu suspenziu
Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg 
Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg tableta
11 Arkoleon Str., Patissia 10445, Greece 
Str., Patissia 10445, Greece
L. Mesogeion 501, 15343 Athens, Greece 
Mesogeion 501, 15343 Athens, Greece
Tussal Expectorans 
VICKS EXPECTORANT
Zerinol Gola ribes nero 
Zerinol Gola ribes nero tableta
ARISTO PHARMA IBERICA, S.L. 
PHARMA IBERICA, S.L.
EGIS PHARMACEUTICALS PLC., 1106 BUDAPEST, Kereszturi ut 30-38, Hungary 
PLC., 1106 BUDAPEST, Kereszturi ut 30-38, Hungary
Romania HEXAL AG, Industriestrasse 25, D- 83607 Holzkirchen, Germany 
Rumunsko HEXAL AG, Industriestrasse 25, D- 83607 Holzkirchen, Germany
Lithuania EGIS PHARMACEUTICALS PLC 
Egis Pharmaceuticals PLC
MUXOL, solution buvable 0,3g per 100 ml of solution 
MUXOL, solution buvable 0,3 g na 100 ml roztoku perorálny roztok
Šmarješka cesta 6 8000 Novo mesto Slovenia 
Šmarješka cesta 6 8000
Luxembourg SCS Boehringer Ingelheim Comm.V. 
Luxembursko SCS Boehringer Ingelheim Comm.V.
9A Loukis Akritas Street Lemesos 
9A Loukis Akritas
Mucoangin 17,86 mg/ml Spray zur Anwendung in der Mundhöhle oromucosal spray oral use 
Mucoangin 17,86 mg/ml Spray zur Anwendung in der Mundhöhle orálna aerodisperzia perorálne použitie
Mucoangin Svartvinbär lozenge 
Mucoangin Svartvinbär pastilka
Medinfar Consumer HealthProdutos Farmacêuticos, Lda. 
Portugalsko Medinfar Consumer HealthProdutos Farmacêuticos, Lda.
RATIOPHARM ESPAÑA S.A. Avda Burgos, 16 D 5ª Planta 28036 Madrid 
Avda Burgos, 16 D 5ª Planta 28036
SURBRONC 60 mg, granulés pour solution buvable en sachet granules for oral solution 
SURBRONC 60 mg, granulés pour solution buvable en sachet granulát na perorálny roztok
Mundipharma Pharmaceuticals Ltd. 13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus 
13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus
Farmoz - Sociedade Técnico Medicinal, S.A. 
Portugalsko Farmoz - Sociedade Técnico Medicinal, S.A.
Ventibron granules for suspension 
Ventibron granulát na suspension
08174 Sant Cugat del Vallés Barcelona 
Cugat del Vallés Barcelona
Romania Zentiva, k.s. 
Rumunsko Zentiva, k.s.
Rexambro 20mg, zuigtabletten lozenge 
Rexambro 20mg, zuigtabletten pastilka
Largo Umberto Boccioni, 1 21040 Origgio Varese Italy 
Largo Umberto Boccioni, 1 21040
1010 Wienna 
1010 Wienna Austria
SURBRONC 60 mg, comprimé enrobé sécable 
SURBRONC 60 mg, comprimé enrobé sécable tableta
Bisolvon drank in sachet, 8 mg oral solution in sachet 
Bisolvon drank in sachet, 8 mg perorálny roztok vo vrecúšku
Procter & Gamble S.R.L. 
& Gamble S.R.L.
Romania BERLIN-CHEMIE AG (Menarini Group) 
BERLIN-CHEMIE AG (MENARINI GROUP)
Romania Farmaceutica REMEDIA S.A. Blv. Metalurgiei nr. 78, sector 4, 041836 Bucureşti, Romania 
Blv. Metalurgiei nr. 78, sector 4, 041836 Bucureşti,
Neo-Bronchol pastille 
Neo-bronchol pastilka
Germany ambroxolum neo-bronchol 15 mg pastile 15 mg pastille 
Germany ambroxolum neo-bronchol 15 mg pastile 15 mg mäkká pastilka
Praha a.s. Telcska 1 
CS. PRAHA a.s Telcska 1
Broncho-Euphyllin retard 30mg, 350mg prolonged-release capsule, hard 
Broncho-Euphyllin retard 30 mg, 350 mg tvrdá kapsula s predĺženým uvoľňovaním
Wick Schleimlöser 75 Einmal Täglich Retardkapseln prolonged-release capsule, hard 
Wick Schleimlöser 75 Einmal Täglich Retardkapseln tvrdá kapsula s predĺženým uvoľňovaním
Avda Bruselas , 24 
S.L. Avda Bruselas
Lysopadol Mint 20mg Lozenges lozenge 
Lysopadol Mint 20mg Lozenges pastilka
Al. Jerozolimskie 146 A 02-305 Warszawa Poland 
A 02-305 Warszawa Poland
30mg/tab tablet 
30 mg/tab tableta
Diamentowa 25 20-471 Lublin Poland 
ul. Diamentowa 25 20-471
Berlin D-12489 
D-12489
SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l'acésulfame potassique et au sorbitol 
AMBROXOL SANS SUCRE, solution buvable édulcorée à l'acésulfame potassique et au sorbitol
Actavis Nordic A/S, Ornegardsvej 16, 2820 Gentofte, Denmark bromhexine hydrochloride 
Actavis Nordic A/S, Ornegardsvej 16, 2820 Gentofte, Denmark bromhexíniumchlorid Bromhexin Actavis 8 mg tablets tableta
Bisolvon druppels voor kinderen, oplossing 2 mg/ml 
Bisolvon druppels voor kinderen, oplossing 2 mg/ml perorálny roztok
Medis Adria d.o.o. 
Chorvátsko Medis Adria d.o.o.
Mucosolvan Bambini suppository rectal use 
Mucosolvan Bambini čapík rektálne použitie
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France ambroxol (chlorhydrate d') 
Francúzsko MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Wałbrzyska 13 60-198 Poznań Poland 
ul. Wałbrzyska 13 60-198
Estrada de Paço de Arcos, 88 - Cacém Park, Armazém 27 2735-307 Agualva-Cacém Portugal 
Estrada de Paço de Arcos, 88 - Cacém Park, Armazém 27
Surbronc coated tablet 
Surbronc obalená tableta
0.12 mg/ 0.025 mg oximetazolin -klorid/dose (0.1 ml). 
0,12 mg/0,0 25 mg oxymetazolín chlorid/dávk a (0,1 ml)
Ambroxolhydrochloride Cyathus 10 mg/Sprühstoß Lösung zum Einnehmen 
Ambroxolhydrochloride Cyathus 10 mg/Sprühstoß Lösung zum Einnehmen perorálny roztok
28850 Torrejón de Ardoz Madrid 
Torrejón de Ardoz Madrid Spain
Ανφαρμ Ellas A.E., Perikleous 53-57 Gerakas 15344, Greece 
Perikleous 53-57 Gerakas 15344, Greece
Motosol 7,5 mg/ml solucion inyectable solution for injection intravenous use 
Motosol 7,5 mg/ml solucion inyectable injekčný roztok intravenózne použitie
Ambroxol 1A Pharma 7,5 mg/ml - Lösung 
Ambroxol 1A Pharma 7,5 mg/ml - Lösung perorálny roztok
2740-245 Porto Salvo Portugal 
2740-245 Porto Salvo Portugal ambroxol
Flavamed tablety 
Flavamed tableta
4 mg per tablet 
4 mg na tabletu tableta
Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringergasse 5-11 Vienna 
& Co KG Dr. Boehringergasse 5-11 Vienna
Ambroxol WICK Schleimlöser für Kinder 3mg/ml Lösung zum Einnehmen 
Ambroxol WICK Schleimlöser für Kinder 3mg/ml Lösung zum Einnehmen perorálny roztok