FrancophonIA/ELRC3.0 huggingface dataset:
English: • Potential risk of teratogenicity o To check pregnancy status before starting treatment o To educate female patients of child-bearing potential on the need for effective contraception before starting, and during treatment with teriflunomide o To inform their doctor immediately if they stop contraception, or prior to changing contraceptive measures o If female patients become pregnant despite using contraceptive measures, they should stop teriflunomide and contact their doctor immediately who should: Consider and discuss with the patient the accelerated elimination procedure encourage them to enrol in a pregnancy registry (in countries where a pregnancy registry is on-going),
Danish: o Hvis en kvinde bliver gravid på trods af anvendelse af antikonception, skal hun stoppe med at tage teriflunomid og straks kontakte sin læge, som vil: Overveje og drøfte den accelerede eliminationsprocedure med kvinden.
English: Cardiac disorders
Danish: Hjerteforstyrrelser
English: Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Danish: Derfor forventes dosisjustering ikke at være nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: Serious side effects
Danish: Bivirkninger
English: Asthenia
Danish: Neglelidelser
English: Sat
Danish: Asteni
English: • Risk of hypertension o to check for a history of hypertension and that blood pressure should be appropriately managed during treatment o the need for blood pressure checks before treatment and periodically during treatment,
Danish: • Risiko for leverpåvirkning o Leverfunktionstest er nødvendige før behandling og periodevist under behandlingen.
English: Musculoskeletal and connective tissue disorders
Danish: Potente CYP- og transport-induktorer
English: AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Danish: 5.1 for vigtig information om de populationer, for hvilke effekt er fastslået).
English: Other side effects can occur with the following frequencies: Very common (may affect more than 1 in 10 people) Headache
Danish: Andre bivirkninger kan forekomme med følgende hyppigheder:
English: Increase in ALT (increase in blood levels of certain hepatic enzymes) shown in tests Hair thinning
Danish: - Laboratorieværdier: Et nedsat antal røde blodlegemer (anæmi), ændring i testresultater for lever og hvide blodlegemer (se pkt.
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Danish: FR - Frankrig EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesvej og indehavere af markedsføringstilladelser i medlemsstaterne
English: HU - Hungary sanofi-aventis zrt.
Danish: HU - Ungarn sanofi-aventis zrt.
English: PL - Poland Zentiva a.s. U Kabelovny 130
Danish: PL - Polen Zentiva a.s. U Kabelovny 130
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Danish: HU - Ungarn PannonPharma Kft. Pannonpharma út 1.
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Danish: PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Danish: HU - Ungarn Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
English: 50 MG/5ML Oral suspension Oral use
Danish: 50 MG/5ML Oral suspension Oral anvendelse
English: Evropská 846/176a 160 00 Prague Czech republic
Danish: Evropská 846/176a 160 00 Prague
English: Damastown - Dublin Ireland
Danish: Damastown - Dublin
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Danish: FR - Frankrig CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Danish: LEOVAN, M. LEWN & SIA EE Argonafton 22
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Danish: PL - Polen Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
English: 200 MG/SUPP Suppository
Danish: 200 MG/SUPP Suppositorier
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Danish: BG - Bulgarien Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Danish: EVAGGELOS KALOFOLIAS & SIA O.E.
English: Kato Patissia 10445
Danish: Kato Patissia 10445 Greece
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Danish: SK - Slovakiet Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: 25125 Brescia Italy
Danish: 25125 Brescia
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Danish: ALET PHARMACEUTICALS M. Alexander 121
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Danish: S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Danish: BG - Bulgarien Sopharma AD 16 Iliensko shosse str. 1220 Sofia
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Danish: FR - Frankrig THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Danish: BG - Bulgarien Actavis EAD 29 Atanas Dukov str. Sofia 1407
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Danish: BG - Bulgarien CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
English: New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
Danish: IT - Italien New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
English: SI - Slovenia CSC Pharma d.o.o.
Danish: SI - Slovenien CSC Pharma d.o.o.
English: Agia Varvara 12351
Danish: Agia Varvara 12351 Greece
English: Benedetti & Co spa Via Bolognese,
Danish: IT - Italien Benedetti & Co spa Via Bolognese,
English: N. Psychiko 15451
Danish: N. Psychiko 15451 Greece
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Danish: IT - Italien Almus Srl Via Cesarea, 11/10 16121 Genova Italy
English: AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Danish: AT - Østrig CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Danish: BG - Bulgarien Inbiotech Ltd 5A Triaditza str.
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Danish: CY - Kypern CHR. K. UNIMED LTD 21 Davlou
English: Largo Boccioni 1 21040 Origgio Varese Italy
Danish: 21040 Origgio Varese Italy
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Danish: BIOMEDICA-CHEMICA A.E. G. Lyra 25
English: EL - Greece RAFARM AEBE Korintou 12
Danish: RAFARM AEBE Korintou 12
English: EL - Greece INTERMED ABEE Kalyftaki 27
Danish: INTERMED ABEE Kalyftaki 27
English: So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
Danish: IT - Italien So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
English: Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
Danish: IT - Italien Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
English: Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia Italy
Danish: IT - Italien Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Danish: S.C. MAGISTRA C&C S.R.L.
English: Dolni Mecholupy Praha 10, CZ-10237 Czech Republic
Danish: Dolni Mecholupy Praha 10, CZ-10237
English: Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma Italy
Danish: IT - Italien Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Danish: VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM) Italy
Danish: IT - Italien C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM)
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Danish: CY - Kypern CODAL SYNTO LTD 33 Thekla Lysioti str.
English: Laboratori Alter Srl Via Egadi, 7
Danish: IT - Italien Laboratori Alter Srl Via Egadi, 7
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Danish: BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
English: Selvi Laboratorio Bioterapico Spa Via Procoio, 28
Danish: IT - Italien Selvi Laboratorio Bioterapico Spa Via Procoio, 28
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Danish: Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Danish: MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Danish: PHARMACYPRIA HELLAS A.E. Paster 6
English: AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Danish: AT - Østrig CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Danish: COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235 Greece
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Danish: ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
Danish: IT - Italien Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Danish: CY - Kypern CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Danish: Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Danish: FARMANIC CHEMIPHARMA S.A. Fylis 137
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Danish: NORMA HELLAS A.E. Menandrou 54
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Danish: PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: Industriestrasse, 25 D-83607 HolzkirchenGermany
Danish: D-83607 HolzkirchenGermany
English: Palaio Faliro Attikis 17564
Danish: Palaio Faliro Attikis 17564 Greece
English: Germed Pharma Spa Via Cesare Cantù, 11
Danish: IT - Italien Germed Pharma Spa Via Cesare Cantù, 11
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Danish: CY - Kypern MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Danish: VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: LT - Lithuania Zentiva k.s.
Danish: LT - Litauen Zentiva k.s.
English: BG - Bulgaria Zentiva k.s.
Danish: BG - Bulgarien Zentiva k.s.
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Danish: MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Danish: 21ST Km National Highway Athens-Lamia 14565 Greece
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Danish: S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti Romania
English: Aesculapius Farmaceutici Srl Via Cozzaglio, 24
Danish: IT - Italien Aesculapius Farmaceutici Srl Via Cozzaglio, 24
English: Suppository
Danish: Suppositorier
English: Laboratori Guidotti S.p.A (Menarini Group).
Danish: CZ - Tjekkiet Laboratori Guidotti S.p.A (Menarini Group).
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Danish: REMEK PHARMACEUTICALS ABEE Pentelis 34
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Danish: FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Danish: BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano Italy
Danish: IT - Italien Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano
English: Levofarma Srl Via Conforti, 42
Danish: IT - Italien Levofarma Srl Via Conforti, 42
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Danish: AULIN, granule pentru suspensie orală, 100 mg/plic
English: PL - Poland Medicom International s.r.o.
Danish: PL - Polen Medicom International s.r.o.
English: HU - Hungary Lab. Guidotti S.p.A.
Danish: HU - Ungarn Lab. Guidotti S.p.A.
English: SIAR Pharma Srl Via Verdi, 33
Danish: IT - Italien SIAR Pharma Srl Via Verdi, 33
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Danish: S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti Romania
English: Kato Kifissia 14564
Danish: Kato Kifissia 14564 Greece
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Danish: Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Danish: REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451 Greece
English: Actavis Group PTC EHF Reykjavikurvegi 76-78 Hafnarf Joerdur Iceland
Danish: IT - Italien Actavis Group PTC EHF Reykjavikurvegi 76-78
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Danish: ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A Holargos 15562
English: Capsule
Danish: Kapsler
English: Orodispersible tablet Oral use
Danish: Overtrukne tabletter Oral anvendelse
English: Kamatero Attikis 13451
Danish: Kamatero Attikis 13451 Greece
English: SK - Slovakia Medicom International s.r.o.
Danish: SK - Slovakiet Medicom International s.r.o.
English: Athens 14564
Danish: Athens 14564 Greece
English: 20144 Milano Italy
Danish: 20144 Milano
English: I.B.N.
Danish: B.I.
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Danish: 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: Mylan Spa Via Vittor Pisani, 20 20124 Milano Italy
Danish: IT - Italien Mylan Spa Via Vittor Pisani, 20 20124 Milano
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Danish: LABORATORI GUIDOTTI SpA Via Livornese, 897
English: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Danish: LV - Letland Medochemie Ltd. Constantinoupoleos Str. 1-10 Limassol, CY-3011
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Danish: Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Danish: U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: SK - Slovakia Laboratori Guidotti S.p.A.
Danish: SK - Slovakiet Laboratori Guidotti S.p.A.
English: Eg S.p.A.
Danish: S.J.A.
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Danish: 30 Km Athens-Lavrion Markopoulo 19003 Greece
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Danish: BG - Bulgarien Laboratori Guidotti S.p.A.
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Danish: NIMESIL, granule pentru suspensie orală, 100 mg
English: 100mg/sachet Granules for oral suspension
Danish: 100mg/brev Granulat til oral suspension
English: Viale Papiniano, 22/B 20100 Milano Italy
Danish: IT - Italien MDM Spa Viale Papiniano, 22/B 20100 Milano
English: LT - Lithuania Laboratori Guidotti S.p.A.
Danish: LT - Litauen Laboratori Guidotti S.p.A.
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Danish: Athinas 22 & Apollonos Gerakas Attikis 15344 Greece
English: EL - Greece FARMILIA E.E.
Danish: FARMILIA E.E.
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Danish: MED-ONE S.A., HELLAS Parnithos Avenue 211 Aharnai 13671
English: Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
Danish: IT - Italien Sandoz Spa Largo U. Boccioni, 1
English: Sarda Pharmaceutica Srl Via Castiglione, 92/B 09100 Cagliari Italy
Danish: IT - Italien Sarda Pharmaceutica Srl Via Castiglione, 92/B
English: LT - Lithuania Medochemie Ltd. P.O.
Danish: LT - Litauen Medochemie Ltd. P.O. Box 51409
English: Union Health Srl Via Roccamandolfi, 1 00156 Roma Italy
Danish: IT - Italien Union Health Srl Via Roccamandolfi, 1
English: Sofar Spa Via Isonzo, 8 20100 Milano Italy
Danish: IT - Italien Sofar Spa Via Isonzo, 8
English: EL - Greece ANTOR EPE P. Mavromihali 1
Danish: ANTOR EPE P. Mavromihali 1 Vrilissia 15235 Greece
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Danish: Viale Fulvio Testi, 330
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Danish: 18th Km Marathonos Avenue Pallini Attikis 15351
English: LV - Latvia
Danish: Ilfov, Romania
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Danish: LAVIPHARM HELLAS A.E. Agias Marinas Paiania Attikis 19002 Greece
English: Ratiopharm GmbH Graf-Arcostrasse, 2 ULM D-89070
Danish: IT - Italien Ratiopharm GmbH Graf-Arcostrasse, 2
English: Savio Srl Via E. Bazzano, 14 16019 Ronco Scrivia (GE) Italy
Danish: 16019 Ronco Scrivia (GE) Italy
English: Athens 10438
Danish: Favierou 48 Athens 10438 Greece
English: FARMA A.E. Aristotelous 73
Danish: FARMA A.E. Aristotelous 73 Athens 10434 Greece
English: Ranbaxy Italia Spa Piazza Filippo Meda, 3 20121 Milano Italy
Danish: IT - Italien Ranbaxy Italia Spa Piazza Filippo Meda, 3
English: Granules for oral solution in sachet
Danish: Granulat til oral opløsning i brev
English: EL - Greece S.J.A.
Danish: IT - Italien Eg S.p.A.
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Danish: LT - Litauen Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
English: Farmac.Damor Spa Via Emilio Scaglione, 27 80145 Napoli Italy
Danish: IT - Italien Farmac.Damor Spa Via Emilio Scaglione, 27
English: FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
Danish: FR - Frankrig HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
English: Helsinn Birex Pharmac.Ltd Mulhuddart, 15
Danish: IT - Italien Helsinn Birex Pharmac.Ltd Mulhuddart, 15
English: CZ - Czech Republic
Danish: Czech Republic
English: Coated tablet
Danish: Filmovertrukne tabletter
English: Medicom International, s.r.o.
Danish: CZ - Tjekkiet Medicom International, s.r.o.
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Danish: Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg
English: EL - Greece B.I.
Danish: IT - Italien I.B.N.
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Danish: ES - Spanien HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Danish: ARMEDICA A.E. Agias Markellis 17 Athens 11855
English: Angenerico Spa Via Nocera Umbra, 75 00181 Roma Italy
Danish: IT - Italien Angenerico Spa Via Nocera Umbra, 75
English: 56010 Pisa-La Vettola
Danish: 56010 Pisa-La Vettola Italy
English: Teva Italia Srl Via Messina, 38 20154 Milano Italy
Danish: IT - Italien Teva Italia Srl Via Messina, 38
English: Piam Farmaceutici Spa Via Padre G. Semeria, 5 16131 Genova Italy
Danish: IT - Italien Piam Farmaceutici Spa Via Padre G. Semeria, 5
English: Italy
Danish: Iceland
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Danish: IT - Italien Lab.Guidotti Spa Via Livornese, 897
English: Agips Farmaceutici Srl Via Amendola, 4 16035 Rapallo (GE) Italy
Danish: IT - Italien Agips Farmaceutici Srl Via Amendola, 4
English: Ecobi Farmaceutici sas Via E. Bazzano, 26 16019 Ronco Scrivia (GE) Italy
Danish: IT - Italien Ecobi Farmaceutici sas Via E. Bazzano, 26
English: EL - Greece BROS EPE Avgis & Gallinis 15
Danish: BROS EPE Avgis & Gallinis 15 N. Kifissia 14564 Greece
English: Dorom Srl Via Messina, 38 20154 Milano Italy
Danish: IT - Italien Dorom Srl Via Messina, 38
English: Pensa Pharma Spa Via Rosellini Ippolito, 12 20124 Milano Italy
Danish: IT - Italien Pensa Pharma Spa Via Rosellini Ippolito, 12
English: Pantafarm Srl Via Palestro, 14 00185 Roma Italy
Danish: IT - Italien Pantafarm Srl Via Palestro, 14
English: 100 MG/TAB Effervescent tablet Oral use
Danish: 100 MG/BREV Granulat til oral opløsning
English: Athens 11855
Danish: 00185 Roma
English: Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Danish: IT - Italien Doc Generici Srl Via Manuzio, 7
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Danish: MEDOCHEMIE LTD. - CYPRUS, P.O. Box 51409
English: Crinos spa Via Pavia, 6 20136 Milano Italy
Danish: IT - Italien Crinos spa Via Pavia, 6
English: The warnings are appropriate.
Danish: Advarslerne er hensigtsmæssige.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Danish: Det aktive stof er velkendt og findes i veterinærlægemidler, der allerede er godkendt i EU.
English: Add the following text in the relevant sections of the product information:
Danish: Tilføj følgende tekst i de relevante afsnit af produktinformationen:
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.
Danish: For pour-on-produktet er der 24 berørte medlemsstater, nemlig Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien.
English: Assessment of the data submitted
Danish: Vurdering af de indgivne data
English: The use of the products was not expected to pose a risk for soil, groundwater and surface water.
Danish: Brugen af produktet forventedes ikke at udgøre en risiko for jord, grundvand og overfladevand.
English: The benefit-risk for the products can be considered to be positive.
Danish: Benefit/risk-forholdet for produkterne vurderes at være positivt.
English: However, it was considered that information on the possible accumulation of deltamethrin in sediments should be communicated to the user in the product information.
Danish: Det blev imidlertid vurderet, at oplysninger om den mulige akkumulering af deltamethrin i sedimenter bør meddeles brugeren i produktinformationen.
English: Using these data PNECs were derived using the appropriate assessment factors.
Danish: Ved hjælp af disse data blev PNEC udarbejdet ved hjælp af de relevante vurderingsfaktorer.
English: As the PECgroundwater was below 0.1 µg/l no further assessment for the water compartment was required.
Danish: Da PECgrundvand lå under 0,1 µg/l, krævedes der ingen yderligere vurdering af vandarealet.
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of the products.
Danish: Den indeholdt alle de oplysninger, der var nødvendige for at kunne drage en konklusion om miljørisikoen ved brug af produkterne.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Danish: Under hensyntagen til de indsendte data kom udvalget med hensyn til de punkter, der i meddelelsen blev rejst af Tyskland og Nederlandene, frem til følgende konklusioner.
English: Risk management or mitigation measures
Danish: Risikostyring eller risikobegrænsningsforanstaltninger
English: Scientific justifications were provided for the cases of deviations from guidelines and a number of peer reviewed publications were submitted.
Danish: Der blev her fremlagt videnskabelige begrundelser for tilfælde af afvigelser fra retningslinjerne samt en række publikationer gennemgået ved peer review.