FrancophonIA/ELRC3.0 huggingface dataset:
French: FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
Danish: Grœkenland FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
French: Royaume-Uni Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Danish: Storbritannien Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
French: Royaume-Uni Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Danish: Storbritannien Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
French: FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Danish: Grœkenland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
French: Royaume-Uni Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Danish: Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
French: Royaume-Uni Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Danish: Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
French: Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Danish: Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
French: Allemagne PharmaSelect GmbH Am Saegewerk 13
Danish: Tyskland PharmaSelect GmbH Am Saegewerk 13
French: Allemagne SIEMENS & CO Postfach 1262
Danish: Tyskland SIEMENS & CO Postfach 1262
French: Allemagne AAI Deutschland GmbH & Co.KG Wegenerstr.
Danish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
French: HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Danish: Grœkenland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
French: Danemark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Danish: Danmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
French: Royaume-Uni Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Danish: Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
French: Allemagne Holsten Pharma GmbH Im Buergerstock 7
Danish: Tyskland Holsten Pharma GmbH Im Buergerstock 7
French: Royaume-Uni CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Danish: Storbritannien CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
French: SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Danish: Slovenien SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
French: ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Danish: Grœkenland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
French: Slovaquie GlaxoSmithKline Slovakia s.r.o.
Danish: GlaxoSmithKline Slovakia s.r.o.
French: Allemagne Desitin Arzneimittel GmbH Postfach 630164
Danish: Tyskland Desitin Arzneimittel GmbH Postfach 630164
French: LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Danish: Grœkenland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
French: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Danish: Grœkenland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
French: 1 ISRS correspond à « Inhibiteur Sélectif de la Recapture de la Sérotonine ».
Danish: 1 SSRI står for ‘Serotonin-Selective Reuptake Inhibitor' (selektiv serotonin-genoptagelseshæmmer).
French: Allemagne TEVA Generics GmbH Kandelstr.
Danish: Tyskland TEVA Generics GmbH Kandelstr.
French: Royaume-Uni Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Danish: Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
French: RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Danish: Grœkenland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
French: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Danish: Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
French: Royaume-Uni Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Danish: Storbritannien Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
French: Danemark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Danish: Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
French: Danemark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Danish: Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
French: Le CHMP a reconnuqu'il existait un signal potentiel d'une augmentation de comportement suicidaire, comprenant des tentatives de suicide et des idées suicidaires et/ou des comportements associés tels que automutilation, comportement hostile et labilité émotionnelle chez les enfants et adolescents traités par ISRS et IRSN.
Danish: CHMP var enige om, at der forelå potentielle tegn på øget selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd som f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med SSRI og SNRI.
French: Allemagne HEXAL AG Postfach 1263
Danish: Tyskland HEXAL AG Postfach 1263
French: Pays-Bas ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Danish: Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
French: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Danish: Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
French: ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Danish: Grœkenland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
French: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Danish: Grœkenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
French: Allemagne Juta Pharma GmbH Gutenbergstr.
Danish: Tyskland Juta Pharma GmbH Gutenbergstr.
French: SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Danish: Grœkenland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
French: Danemark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Danish: Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
French: Danemark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Danish: Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
French: ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Danish: Grœkenland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
French: Danemark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Danish: Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
French: Allemagne Winthrop Arzneimittel GmbH Industriestr.
Danish: Tyskland Winthrop Arzneimittel GmbH Industriestr.
French: Cipralex Oral Drops
Danish: Cipralex Orale dråber
French: PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Danish: Grœkenland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
French: VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Danish: Grœkenland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
French: - Le Comité, au vu des données disponibles issues des études cliniques, a conclu qu'il existait un signal de comportement de type suicidaire, comprenant des tentatives de suicide et des idées suicidaires et/ou des comportements associés tels que automutilation, comportement hostile et labilité émotionnelle chez les enfants et adolescents traités par Inhibiteurs Sélectifs de la Recapture de la Sérotonine et Inhibiteurs de la Recapture de la Sérotonine et de la Noradrénaline, tels que les médicaments sus-mentionnés ;
Danish: - Udvalget konkluderede på baggrund af de tilgængelige data fra kliniske undersøgelser, at der er signaler på selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd, f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med selektive serotonin-genoptagelseshæmmere og serotonin-noradrenalingenoptagelseshæmmere, såsom de ovennævnte lægemidler.
French: ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777 Elliniko, Greece
Danish: Grœkenland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
French: Si l'un de ces symptômes apparaît ou s'aggrave après le début du traitement, vous devez en informer votre médecin.
Danish: Du bør underrette din læge, hvis nogle af ovennævnte symptomer opstår eller forværres efter påbegyndt behandling.
French: Royaume-Uni Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Danish: Storbritannien Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
French: Vous devez également savoir que, comme avec les autres traitements psychotropes, la possibilité rare que des effets indésirables psychiatriques graves surviennent ne peut être exclue.
Danish: Der gøres opmærksom på, at sjældne, alvorlige psykiatriske bivirkninger ligesom ved anvendelse af andre psykotrope lægemidler ikke kan udelukkes.
French: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Danish: Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
French: Royaume-Uni Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Danish: Storbritannien Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
French: Zoloft 25 mg + 50 mg 25 mg + 50 mg Comprimé pelliculé
Danish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmovertrukket tablet
French: Danemark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Danish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
French: Avenue Mercator 1 1300 Wavre, Belgium
Danish: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
French: Danemark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Danish: Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
French: Allemagne Esparma GmbH Postfach 1461
Danish: Tyskland Esparma GmbH Postfach 1461
French: GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Danish: Grœkenland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
French: WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Danish: Grœkenland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
French: Allemagne Neuraxpharm Arzneimittel GmbH & Co.KG
Danish: Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG
French: Allemagne Krewel Meuselbach GmbH Postfach 1263
Danish: Tyskland Krewel Meuselbach GmbH Postfach 1263
French: État Membre Détenteur de l'autorisation de mise sur le marché
Danish: Medlemsland Indehaver af markedsføringstilladelsen
French: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
French: MOTIFS DE MODIFICATION DES RÉSUMÉS DES CARACTÉRISTIQUES DU PRODUIT
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE
French: 2 IRSN correspond à « Inhibiteur de la Recapture de la Sérotonine et de la Noradrénaline ».
Danish: 2 SNRI står for ‘Serotonin-Norepinephrine Reuptake Inhibitor' (serotonin-noradrenalin-genoptagelseshæmmer).
French: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Danish: Grœkenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
French: IV.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DE LA NOTICE DU PRODUIT CONCERNANT L'ATOMOXÉTINE
Danish: IV.2 ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR ATOMOXETIN
French: Danemark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Danish: Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
French: Danemark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Danish: Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
French: Danemark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Danish: Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
French: Allemagne Hormosan-Kwizda GmbH Postfach 600340
Danish: Tyskland Hormosan-Kwizda GmbH Postfach 600340
French: Allemagne Merck dura GmbH Postfach 100635
Danish: Tyskland Merck dura GmbH Postfach 100635
French: Danemark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Danish: Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
French: Danemark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Danish: Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
French: Allemagne Heumann Pharma GmbH & Co. Generica KG
Danish: Tyskland Heumann Pharma GmbH & Co. Generica KG
French: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
French: Royaume-Uni Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Danish: Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
French: Allemagne Lundbeck GmbH Postfach 900662
Danish: Tyskland Lundbeck GmbH Postfach 900662
French: Allemagne Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Danish: Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
French: Allemagne Sandoz Pharmaceuticals GmbH Dieselstr.
Danish: Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
French: Danemark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Danish: Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
French: Royaume-Uni Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Danish: Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
French: Vous devez également savoir que la sécurité à long terme sur la croissance, la maturation et le développement comportemental et cognitif de [Nom de Fantaisie] n'a pas encore été établie dans cette tranche d'âge.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
French: Allemagne Alpharma-ISIS GmbH & Co.
Danish: Tyskland Alpharma-ISIS GmbH & Co.
French: Danemark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Danish: Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
French: Allemagne Solvay Arzneimittel GmbH Postfach 220
Danish: Tyskland Solvay Arzneimittel GmbH Postfach 220
French: Danemark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Danish: Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
French: Allemagne IIP-Institut fuer industrielle Pharmazie Benzstr.
Danish: Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
French: Royaume-Uni Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Danish: Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
French: Royaume-Uni Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Danish: Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
French: Allemagne BC Biochemie Pharma GmbH Dieselstr.
Danish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
French: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Danish: Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
French: Allemagne STADA GmbH Stadastr.
Danish: Tyskland STADA GmbH Stadastr.
French: Royaume-Uni Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Danish: Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
French: Slovaquie Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Danish: 16, Chemin de Coquelicots CH - 1214 Geneva
French: Un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle ont été plus fréquemment observés au cours d'études cliniques chez les enfants et adolescents traités par [Nom de Fantaisie] par rapport à ceux traités par placebo.
Danish: Fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med [særnavn] sammenholdt med gruppen behandlet med placebo.
French: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
French: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Danish: Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
French: Allemagne Wyeth Pharma GmbH Postfach 8806
Danish: Tyskland Wyeth Pharma GmbH Postfach 8806
French: ANNEXE IV MODIFICATIONS DE LA NOTICE DU PRODUIT
Danish: BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
French: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Danish: Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
French: Slovaquie Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Danish: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
French: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Danish: Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
French: Royaume-Uni Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Danish: Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
French: Fabrik , Holger Danskaes Vej 89, DK - 2000
Danish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
French: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Danish: Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
French: Allemagne Boehringer Ingelheim Pharma GmbH & Co.KG
Danish: Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
French: III.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DU RCP DE L'ATOMOXÉTINE
Danish: III.2 ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR ATOMOXETIN
French: Allemagne Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Danish: Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
French: ANNEXE III MODIFICATIONS DU RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT
Danish: BILAG III ÆNDRINGER I PRODUKTRESUMEET
French: Allemagne Pharmacia GmbH Pfizerstr.
Danish: Tyskland Pharmacia GmbH Pfizerstr.
French: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
French: ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Danish: Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
French: Allemagne Aliud Pharma GmbH & Co.KG Postfach 1380
Danish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
French: Allemagne Temmler Pharma GmbH & Co.KG Postfach 2269
Danish: Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
French: GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Danish: Grœkenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
French: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Danish: Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
French: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Danish: Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
French: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danish: Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
French: Danemark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Danish: Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
French: Danemark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
French: Entact Oral Drops
Danish: Entact Orale dråber
French: Danemark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Danish: Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
French: Considérant que - Le Comité a pris en compte la saisine en vertu de l'article 31 de la Directive 2001/83/CE, telle que modifiée, concernant les spécialités pharmaceutiques contenant de l'atomoxétine, du citalopram, de l'escitalopram, de la fluoxétine, de la fluvoxamine, de la miansérine, du milnacipran, de la mirtazapine, de la paroxétine, de la reboxétine, de la sertraline et de la venlafaxine ;
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin.
French: Royaume-Uni John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Danish: Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
French: Allemagne Biomo pharma GmbH Josef-Dietzgen-Str. 3
Danish: Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
French: Allemagne biomo pharma GmbH Josef-Dietzgen-Str. 3
Danish: Tyskland Biomo pharma GmbH Josef-Dietzgen-Str. 3
French: Royaume-Uni Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Danish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: Danemark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
French: Allemagne H.Lundbeck A/S Ottiliavej 7-9
Danish: H.Lundbeck A/S Ottiliavej 7-9
French: Forme Pharmaceutique Voie d'administration
Danish: Lœgemiddelform Indgivelsesvej
French: Allemagne Lilly Deutschland GmbH Saalburgstr.
Danish: Tyskland Lilly Deutschland GmbH Saalburgstr.
French: Allemagne TAD Pharma GmbH Postfach 720
Danish: Tyskland TAD Pharma GmbH Postfach 720
French: Royaume-Uni KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Danish: Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
French: Royaume-Uni Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Danish: Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
French: Allemagne Rodleben Pharma GmbH Postfach 205
Danish: Tyskland Rodleben Pharma GmbH Postfach 205
French: Danemark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
French: Royaume-Uni Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: Danemark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Danish: Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
French: Allemagne Woerwag Pharma GmbH & Co.
Danish: Tyskland Woerwag Pharma GmbH & Co.
French: Royaume-Uni Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: Danemark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany