FrancophonIA/ELRC3.0 huggingface dataset:
English: If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma concentration below 0.02 mg/l.
Czech: 0,02 mg/l v průměru dalších 8 měsíců, u některých pacientů však může klesání plazmatické koncentrace pod úroveň 0,02 mg/l trvat až 2 roky.
English: TOPIC was a double-blind, placebo-controlled study that evaluated once daily doses of teriflunomide 7 mg and 14 mg for up to 108 weeks in patients with first clinical demyelinating event (mean age 32.1 years).
Czech: 14 mg jednou denně až po 108 týdnů u pacientů s první příhodou demyelinizace (průměrný věk 32,1 let).
English: Based on the half-life of fingolimod, a 6-week interval without therapy is needed for clearance from the circulation and a 1 to 2 month period is needed for lymphocytes to return to normal range following discontinuation of fingolimod.
Czech: Lymfocyty se vrací do normálního rozpětí 1 až 2 měsíce po ukončení léčby fingolimodem.
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration of teriflunomide should also be undertaken with caution.
Czech: reduktázy, zejména ze skupiny OATP (např. simvastatinu, atorvastatinu, pravastatinu, methotrexátu, nateglinidu, repaglinidu či rifampicinu) v kombinaci s teriflunomidem je také nutné postupovat opatrně.
English: Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Czech: Teriflunomid je kontraindikován v období kojení (viz bod 4.3).
English: Once the teriflunomide plasma concentration is determined to be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days.
Czech: 0,02 mg/l, je nutné ji opět zkontrolovat po uplynutí alespoň 14 dnů.
English: AUBAGIO 14 mg film-coated tablets teriflunomide
Czech: AUBAGIO 14 mg potahované tablety teriflunomidum
English: A total of 1088 patients with RMS were randomised in TEMSO to receive 7 mg (n=366) or 14 mg (n=359) of teriflunomide or placebo (n= 363) for 108 weeks duration.
Czech: nebo 14 mg (n = 359) teriflunomidu nebo placebo (n = 363) po dobu 108 týdnů.
English: AUBAGIO 14 mg film-coated tablets
Czech: AUBAGIO 14 mg potahované tablety
English: Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that teriflunomide is not an inhibitor or an inducer of CYP2C9.
Czech: Z výše uvedeného vyplývá, že teriflunomid není inhibitorem ani induktorem cytochromu CYP2C9.
English: Each tablet contains 14 mg of teriflunomide.
Czech: Jedna tableta obsahuje teriflunomidum 14 mg.
English: Based on individual prediction of pharmacokinetic parameters using the PopPK model of teriflunomide in healthy volunteers and MS patients, median t1/2z was approximately 19 days after repeated doses of 14 mg. After a single intravenous administration, the total body clearance of teriflunomide is 30.5 ml/h.
Czech: teriflunomidu u zdravých dobrovolníků a pacientů s RS byl t1/2z přibližně 19 dnů po opakovaných dávkách 14 mg.
English: The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Czech: Eliminaci teriflunomidu z oběhu lze zrychlit podáním kolestyraminu nebo aktivního uhlí.
English: No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Czech: U pacientů s lehkou, středně těžkou nebo těžkou poruchou funkce ledvin, kteří nejsou léčeni dialýzou, není nutné provádět žádné úpravy dávkování.
English: Menorrhagia
Czech: POUZDRO
English: Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section 4.6).
Czech: Po ukončení léčby je nutné používat antikoncepci, dokud plazmatické hladiny neklesnou pod 0,02 mg/l (viz bod 4.6).
English: MRI endpoints
Czech: Klinické cílové parametry (endpointy)
English: cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Czech: Dle zkušeností v klinických studiích zřejmě teriflunomid není spojen se zvýšeným rizikem malignity.
English: - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
Czech: - sulfasalazina k léčbě zánětlivých onemocnění střev nebo revmatoidní artritidy - kolestyramin k léčbě vysokou hladinu cholesterolu nebo zmírnění svědění u onemocnění jater - aktivní uhlí ke snížení vstřebávání léků nebo jiných látek
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING PROTECTIVE SLEEVE CONTAINING WALLET
Czech: OCHRANNÝ OBAL OBSAHUJÍCÍ POUZDRO
English: Since teriflunomide is highly protein bound and as the binding is dependent upon the concentrations of albumin, unbound plasma teriflunomide concentrations are expected to be increased in patients with hypoproteinaemia, e.g. in nephrotic syndrome.
Czech: Hypoproteinemie Jelikož se teriflunomid ve značné míře váže na proteiny a míra navázání závisí na koncentracích albuminu,
English: Hypertensionb
Czech: Hypertenzeb
English: Musculoskeletal pain,
Czech: Muskuloskeletální bolest, myalgie, artralgie
English: - The active substance is teriflunomide.
Czech: - Léčivou látkou je teriflunomidum.
English: Teriflunomide is contraindicated in this population (see section 4.3).
Czech: Teriflunomid je v této skupině pacientů kontraindikován (viz bod 4.3).
English: Gammaglutamyltransfer ase (GGT) increaseb, Aspartate aminotransferas
Czech: Zvýšená hladina gamaglutamyltra nsferázyb (GGT),
English: Vomiting, Toothache
Czech: Alopecie Vyrážka, akné
English: Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Czech: Pokud plánujete po ukončení léčby přípravkem AUBAGIO otěhotnět, informujte o tom svého lékaře.
English: How to store AUBAGIO
Czech: Jak přípravek AUBAGIO uchovávat
English: Calendar days Mon
Czech: Kalendářní dny
English: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Czech: U pacientů s lehkou nebo středně těžkou poruchou funkce jater není nutné provádět žádnou úpravu dávkování.
English: How to take AUBAGIO
Czech: Co je přípravek AUBAGIO
English: If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three times a day can be used.
Czech: Pokud pacient toleruje kolestyramin v dávce 8 g třikrát denně špatně,
English: The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.
Czech: není zcela znám, je však založen na snížení počtu lymfocytů.
English: This stops nerves from working properly.
Czech: Za tuto dobu se přípravek eliminuje z oběhu.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports (PSURs)
Czech: C. DALŠÍ PODMÍNKY A POŽADAVKY REGISTRACE
English: Influenza, Upper respiratory tract infection, Urinary tract infection, Bronchitis, Sinusitis, Pharyngitis, Cystitis, Gastroenteritis viral,
Czech: infekce horních cest dýchacích, infekce močových cest,
English: Vascular disorders
Czech: JEDNODÁVKOVÝ BLISTR
English: Tue
Czech: nauzea
English: - Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
Czech: - bolest šlach, kloubů, kostí, svalů (muskuloskeletální bolest) - potřeba močit častěji, než je běžné
English: - if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Czech: - pokud máte závažnou infekci, - jestliže máte závažné problémy s ledvinami, které vyžadují dialýzu, - pokud máte velmi nízkou hladinu bílkovin v krvi (hypoproteinemie).
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Czech: Seznam názvů léčivých přípravků, lékové formy, koncentrace, způsob podání a držitelé rozhodnutí o registraci v členských státech
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Czech: FR - Francie EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
English: HU - Hungary sanofi-aventis zrt.
Czech: HU - Maďarsko sanofi-aventis zrt.
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Czech: HU - Maďarsko PannonPharma Kft. Pannonpharma út 1.
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Czech: PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Czech: HU - Maďarsko Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
English: 2114 Aglantzia
Czech: 2114 Aglantzia Lefkosia
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Czech: FR - Francie CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Czech: EVAGGELOS KALOFOLIAS & SIA O.E.
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Czech: BG - Bulharsko Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Czech: LEOVAN, M. LEWN & SIA EE Argonafton 22
English: Kato Patissia 10445
Czech: Kato Patissia 10445 Greece
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Czech: SK - Slovensko Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Czech: BG - Bulharsko Sopharma AD 16 Iliensko shosse str. 1220 Sofia
English: 25125 Brescia Italy
Czech: 25125 Brescia
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Czech: BG - Bulharsko Actavis EAD 29 Atanas Dukov str. Sofia 1407
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Czech: BG - Bulharsko Inbiotech Ltd 5A Triaditza str.
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Czech: S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Czech: BG - Bulharsko CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Czech: FR - Francie THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: Agia Varvara 12351
Czech: Agia Varvara 12351 Greece
English: SI - Slovenia CSC Pharma d.o.o.
Czech: SI - Slovinsko CSC Pharma d.o.o.
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Czech: ALET PHARMACEUTICALS M. Alexander 121
English: AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Czech: AT - Rakousko CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
English: EL - Greece RAFARM AEBE Korintou 12
Czech: RAFARM AEBE Korintou 12
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Czech: S.C. MAGISTRA C&C S.R.L.
English: N. Psychiko 15451
Czech: N. Psychiko 15451 Greece
English: EL - Greece INTERMED ABEE Kalyftaki 27
Czech: INTERMED ABEE Kalyftaki 27
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Czech: CODAL SYNTO LTD 33 Thekla Lysioti str.
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Czech: BIOMEDICA-CHEMICA A.E. G. Lyra 25
English: AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Czech: AT - Rakousko CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Czech: VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: BG - Bulgaria Zentiva k.s.
Czech: BG - Bulharsko Zentiva k.s.
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Czech: CHR. K. UNIMED LTD 21 Davlou
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Czech: BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Czech: MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Czech: Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Czech: COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235 Greece
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Czech: PHARMACYPRIA HELLAS A.E. Paster 6
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Czech: ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Czech: FARMANIC CHEMIPHARMA S.A. Fylis 137
English: 50 MG/5ML Oral suspension Oral use
Czech: 50 MG/5ML Perorální suspenze Perorální podání
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Czech: NORMA HELLAS A.E. Menandrou 54
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Czech: Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Czech: PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: Dolni Mecholupy Praha 10, CZ-10237 Czech Republic
Czech: Dolni Mecholupy Praha 10, CZ-10237
English: Palaio Faliro Attikis 17564
Czech: Palaio Faliro Attikis 17564 Greece
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Czech: MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Czech: VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Czech: 21ST Km National Highway Athens-Lamia 14565 Greece
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Czech: REMEK PHARMACEUTICALS ABEE Pentelis 34
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Czech: S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti Romania
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Czech: Via Cesarea, 11/10 16121 Genova Italy
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Czech: FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Czech: BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: 3508 Lemessos
Czech: 3508 Lemessos Cyprus
English: 200 MG/SUPP Suppository
Czech: 200 MG/SUPP Čípek
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Czech: AULIN, granule pentru suspensie orală, 100 mg/plic
English: HU - Hungary Lab. Guidotti S.p.A.
Czech: HU - Maďarsko Lab. Guidotti S.p.A.
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Czech: CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: 3505 Lemessos
Czech: 3505 Lemessos Cyprus
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Czech: LABORATORI GUIDOTTI SpA Via Livornese, 897
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Czech: S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti Romania
English: Kato Kifissia 14564
Czech: Kato Kifissia 14564 Greece
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Czech: MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Czech: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5, 95-200 Pabianice
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Czech: Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Czech: REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451 Greece
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Czech: ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A Holargos 15562
English: Kamatero Attikis 13451
Czech: Kamatero Attikis 13451 Greece
English: Athens 14564
Czech: Athens 14564 Greece
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Czech: 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Czech: LV - Lotyšsko Medochemie Ltd. Constantinoupoleos Str. 1-10 Limassol, CY-3011
English: SK - Slovakia Medicom International s.r.o.
Czech: SK - Slovensko Medicom International s.r.o. Páteřní 7
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Czech: Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Czech: BG - Bulharsko Laboratori Guidotti S.p.A.
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Czech: Viale Fulvio Testi, 330 20126 Milano Italy
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Czech: 30 Km Athens-Lavrion Markopoulo 19003 Greece
English: LT - Lithuania Zentiva k.s.
Czech: LV - Lotyšsko Zentiva k.s.
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Czech: NIMESIL, granule pentru suspensie orală, 100 mg
English: SK - Slovakia Laboratori Guidotti S.p.A.
Czech: SK - Slovensko Laboratori Guidotti S.p.A.
English: Orodispersible tablet Oral use
Czech: Potahovaná tableta Perorální podání
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Czech: U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: LV - Latvia
Czech: LT - Litva
English: MG/SACHET
Czech: MG/SÁČEK
English: Páteřní 1216/7
Czech: Medicom International, s.r.o. Páteřní 1216/7
English: EL - Greece FARMILIA E.E.
Czech: FARMILIA E.E.
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Czech: Athinas 22 & Apollonos Gerakas Attikis 15344 Greece
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Czech: MED-ONE S.A., HELLAS Parnithos Avenue 211 Aharnai 13671
English: EL - Greece ANTOR EPE P. Mavromihali 1
Czech: ANTOR EPE P. Mavromihali 1 Vrilissia 15235 Greece
English: Medicom International, s.r.o.
Czech: Medicom International s.r.o. Paterni 7
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Czech: 18th Km Marathonos Avenue Pallini Attikis 15351
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Czech: ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Greece
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Czech: LAVIPHARM HELLAS A.E. Agias Marinas Paiania Attikis 19002 Greece
English: FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
Czech: FR - Francie HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
English: FARMA A.E. Aristotelous 73
Czech: FARMA A.E. Aristotelous 73 Athens 10434 Greece
English: Athens 10438
Czech: Favierou 48 Athens 10438 Greece
English: Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart Dublin-15
Czech: Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Czech: ES - Španělsko HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
English: 56010 Pisa-La Vettola
Czech: 56010 Pisa-La Vettola Italy
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Czech: ARMEDICA A.E. Agias Markellis 17 Athens 11855
English: Limassol, CY-3505
Czech: Medochemie Ltd. P.O. Box 51409 Limassol, CY-3505 Cyprus
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Czech: Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg
English: Ilfov,
Czech: Ilfov, Romania
English: 100 MG/TAB Effervescent tablet Oral use
Czech: 100 MG/TAB Šumivá tableta
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Czech: (Menarini Group) Via Livornese 897
English: LT - Lithuania Laboratori Guidotti S.p.A.
Czech: LV - Lotyšsko Laboratori Guidotti S.p.A.
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Czech: LV - Lotyšsko Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart
English: EL - Greece BROS EPE Avgis & Gallinis 15
Czech: BROS EPE Avgis & Gallinis 15 N. Kifissia 14564 Greece
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Czech: MEDOCHEMIE LTD. - CYPRUS, P.O. Box 51409
English: The warnings are appropriate.
Czech: Tato upozornění jsou přiměřená.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Czech: Léčivá látka je dobře známa a je obsažena ve veterinárních léčivých přípravcích, které jsou v současné době schváleny v EU.
English: For the pour-on product 24 concerned member states (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Czech: Žádost pro přípravek k nalévání na hřbet zahrnuje 24 dotčených členských států: Belgii, Bulharsko, Českou republiku, Dánsko, Estonsko, Francii, Irsko, Island, Itálii, Kypr, Litvu, Lotyšsko, Lucembursko, Maďarsko, Německo, Nizozemsko, Polsko, Portugalsko, Rakousko, Rumunsko, Řecko, Slovensko, Slovinsko a Španělsko.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Czech: Výbor předložené údaje zvážil a poté dospěl k následujícím závěrům ohledně otázek vznesených v oznámení, které obdržel od Německa a Nizozemska.
English: The reference member state (RMS) is the United Kingdom for both products.
Czech: Referenčním členským státem je pro oba přípravky Spojené království.
English: The efficacy of Deltanil has been demonstrated according to current rules during the decentralised procedure.
Czech: Účinnost přípravku Deltanil byla prokázána v souladu se stávajícími pravidly během decentralizovaného postupu.
English: Using these data PNECs were derived using the appropriate assessment factors.
Czech: S pomocí těchto údajů byly odvozeny hodnoty PNEC za použití vhodných hodnotících faktorů.
English: The benefit-risk for the products can be considered to be positive.
Czech: Poměr přínosů a rizik těchto přípravků lze považovat za příznivý.