FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: Nederland Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Danish: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Dutch: Nederland Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Dutch: Denemarken GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Danish: Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Dutch: Litouwen N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Danish: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Dutch: Duitsland Hormosan-Kwizda GmbH Postfach 600340
Danish: Tyskland Hormosan-Kwizda GmbH Postfach 600340
Dutch: Oostenrijk Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Danish: Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Dutch: Denemarken 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
Dutch: Duitsland Merck dura GmbH Postfach 100635
Danish: Tyskland Merck dura GmbH Postfach 100635
Dutch: Nederland Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Danish: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Dutch: Denemarken Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Danish: Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Dutch: Duitsland Solvay Arzneimittel GmbH Postfach 220
Danish: Tyskland Solvay Arzneimittel GmbH Postfach 220
Dutch: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Danish: Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Dutch: Duitsland Sandoz Pharmaceuticals GmbH Dieselstr.
Danish: Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
Dutch: Oostenrijk Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Danish: Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Dutch: 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
Dutch: Griekenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Dutch: III.2 IN DE DESBETREFFENDE PARAGRAAF VAN DE SPC VOOR ATOMOXETINE OP TE NEMEN WIJZIGINGEN
Danish: III.2 ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR ATOMOXETIN
Dutch: Oostenrijk Stada Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria
Danish: Stada Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria
Dutch: Denemarken Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Danish: Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Dutch: Denemarken BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Danish: Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Dutch: Luxemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Danish: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Dutch: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Danish: Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Dutch: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Danish: Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Dutch: Van-der-Smissen-Strasse 1
Danish: KG) Van-der-Smissen-Str. 1
Dutch: Denemarken Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Danish: Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Dutch: BIJLAGE III WIJZIGINGEN VAN DE SAMENVATTING VAN DE PRODUCTKENMERKEN
Danish: BILAG III ÆNDRINGER I PRODUKTRESUMEET
Dutch: Diagonal, 507, 08029 Barcelona, Spanje
Danish: Diagonal, 507, 08029 Barcelona, Spain
Dutch: Denemarken Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Danish: Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Dutch: Nederland Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Danish: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Dutch: Denemarken Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Danish: Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Dutch: Duitsland STADA GmbH Stadastr.
Danish: Tyskland STADA GmbH Stadastr.
Dutch: Luxemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Danish: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Dutch: Wilbury Way
Danish: 1 The Cam Centre Wilbury Way
Dutch: Duitsland Boehringer Ingelheim Pharma GmbH & Co.KG
Danish: Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
Dutch: Griekenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Danish: Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Dutch: Duitsland Heumann Pharma GmbH & Co. Generica KG
Danish: Tyskland Heumann Pharma GmbH & Co. Generica KG
Dutch: SNRI staat voor ‘Selective Norepinephrine Re-uptake Inhibitor' (selectieve norepinefrine-heropnameremmer).
Danish: 2 SNRI står for ‘Serotonin-Norepinephrine Reuptake Inhibitor' (serotonin-noradrenalin-genoptagelseshæmmer).
Dutch: Duitsland Betapharm Arzneimittel GmbH Kobelweg 95
Danish: Tyskland betapharm Arzneimittel GmbH Kobelweg 95
Dutch: Duitsland betapharm Arzneimittel GmbH Kobelweg 95
Danish: Tyskland Betapharm Arzneimittel GmbH Kobelweg 95
Dutch: Nederland Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Danish: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Dutch: Noorwegen Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Danish: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Dutch: Frankrijk WINTHROP médicaments 174 avenue de France
Danish: WINTHROP médicaments 174 avenue de France 75013 Paris
Dutch: Griekenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Danish: Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Dutch: 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
Dutch: 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.
Dutch: Slowakije Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Danish: 16, Chemin de Coquelicots CH - 1214 Geneva
Dutch: 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
Dutch: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Danish: Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Dutch: Duitsland Wyeth Pharma GmbH Postfach 8806
Danish: Tyskland Wyeth Pharma GmbH Postfach 8806
Dutch: Oostenrijk 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
Danish: 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
Dutch: Nederland Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Danish: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Dutch: Noorwegen IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Danish: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Dutch: Litouwen Ranbaxy (UK) Ltd., C.P.
Danish: Ranbaxy (UK) Ltd., C.P.
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Dutch: Griekenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Danish: Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Dutch: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Dutch: Griekenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Danish: Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Dutch: Oostenrijk Hexal Pharma GmbH, Wilhelmimenstr.
Danish: Hexal Pharma GmbH, Wilhelmimenstr.
Dutch: Fabrik , Holger Danskaes Vej 89, DK - 2000
Danish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Dutch: Nederland Hexal AG, Postfach 1263, D-83602 Holzkirchen
Danish: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Dutch: Nederland GenRx B.V.
Danish: GenRx B.V.
Dutch: Griekenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Danish: Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Dutch: Nederland Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Danish: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Dutch: Nederland Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Danish: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Dutch: Duitsland Lilly Deutschland GmbH Saalburgstr.
Danish: Tyskland Lilly Deutschland GmbH Saalburgstr.
Dutch: 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
Dutch: Griekenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Danish: Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Dutch: Slowakije 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
Dutch: Capsule, zacht
Danish: Depotkapsel, blød
Dutch: Nederland Apothecon B.V.
Danish: Apothecon B.V.
Dutch: Duitsland Pfizer Pharma GmbH Pfizerstr.
Danish: Tyskland Pfizer Pharma GmbH Pfizerstr.
Dutch: Nederland Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Danish: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: Duitsland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Danish: Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Dutch: Frankrijk Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Danish: Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Dutch: Langetermijn veiligheids door patiënten jonger dan 18 jaar.gegevens van [Fantasienaam] over groei, ontwikkeling en cognitieve en gedragsontwikkeling ontbreken in deze leeftijdsgroep.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
Dutch: Nederland Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Danish: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Danish: Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Dutch: Frankrijk Lilly France 13 rue pagès
Danish: 13 rue pagès
Dutch: Griekenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Danish: Grœkenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Dutch: In klinische studies werden suïcidaal gedrag (zelfmoordpogingen en zelfmoordgedachten) en vijandigheid (voornamelijk agressie, oppositioneel gedrag en woede) vaker waargenomen bij kinderen en adolescenten die behandeld werden met antidepressiva dan bij degenen die behandeld werden met placebo.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Dutch: Duitsland biomo pharma GmbH Josef-Dietzgen-Str. 3
Danish: Tyskland Biomo pharma GmbH Josef-Dietzgen-Str. 3
Dutch: Duitsland Biomo pharma GmbH Josef-Dietzgen-Str. 3
Danish: Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
Dutch: Luxemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Danish: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Dutch: Filmomhulde tablets
Danish: Filmovertrukket tablets
Dutch: Oropharyngeaal gebruik
Danish: Orofaryngeal anvendelse
Dutch: Griekenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Danish: Grœkenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Dutch: Hongarije Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Danish: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Dutch: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Danish: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Dutch: Denemarken Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Danish: Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Dutch: Griekenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danish: Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Dutch: Oostenrijk Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Danish: Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Dutch: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Danish: Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Dutch: Duitsland Pharmacia GmbH Pfizerstr.
Danish: Tyskland Pharmacia GmbH Pfizerstr.
Dutch: Hongarije Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Danish: Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Dutch: Denemarken Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Danish: Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Dutch: Duitsland Rodleben Pharma GmbH Postfach 205
Danish: Tyskland Rodleben Pharma GmbH Postfach 205
Dutch: Nederland GlaxoSmithKline B.V.
Danish: GlaxoSmithKline B.V.
Dutch: Nederland Genthon B.V.
Danish: Genthon B.V.
Dutch: Medochemie Ltd, P.O.
Danish: Medochemie Ltd., 1-10
Dutch: Entact Oral Drops
Danish: Entact Orale dråber
Dutch: Oostenrijk GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Danish: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Dutch: Luxemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Danish: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Dutch: Hongarije Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Danish: Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Dutch: Duitsland Aliud Pharma GmbH & Co.KG Postfach 1380
Danish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
Dutch: Litouwen ICN Polfa Rzeszow, ul.
Danish: ICN Polfa Rzeszow, ul.
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Danish: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Dutch: Nederland Hexal B.V.
Danish: Hexal B.V.
Dutch: Duitsland TAD Pharma GmbH Postfach 720
Danish: Tyskland TAD Pharma GmbH Postfach 720
Dutch: Litouwen SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Danish: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Dutch: Frankrijk IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Danish: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Danish: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Dutch: Duitsland Temmler Pharma GmbH & Co.KG Postfach 2269
Danish: Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
Dutch: Houder van de vergunning voor het in handel brengen
Danish: Medlemsland Indehaver af markedsføringstilladelsen
Dutch: Frankrijk MG PHARMA 264 Rue du faubourg saint honoré 75008 Paris - France
Danish: 264 Rue du faubourg saint honoré 75008 Paris - France
Dutch: Fantasie naam
Danish: Sœrnavn
Dutch: Denemarken Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Danish: Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Dutch: Concentraat voor oplossing voor injectie
Danish: Koncentrat til injektionsvœske til opløsning
Dutch: Het CHMP kwam tot de conclusie dat in de samenvattingen van de productkenmerken (SPC) en in de desbetreffende rubriek van de bijsluiter van citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline en venlafaxine bevattende geneesmiddelen een passage moest worden opgenomen om te waarschuwen dat suïcidaal gedrag (zelfmoordpogingen en zelfmoordgedachten) en vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woedeuitbarstingen) vaker werden waargenomen in klinische onderzoeken onder kinderen en adolescenten die met antidepressiva behandeld werden dan bij met placebo behandelde jonge patiënten.
Danish: CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Dutch: Duitsland H.Lundbeck A/S Ottiliavej 7-9
Danish: H.Lundbeck A/S Ottiliavej 7-9
Dutch: Frankrijk EG Labo laboratoire Eurogenerics le Quintet Batiment A
Danish: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Dutch: Denemarken Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Dutch: Litouwen Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Danish: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Dutch: Denemarken NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Dutch: Frankrijk GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Danish: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Danish: Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Dutch: Frankrijk PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Danish: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Dutch: - het CHMP dientengevolge tot de conclusie kwam dat in de samenvattingen van de productkenmerken (SPC) en in de desbetreffende rubriek van de bijsluiter van citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine bevattende geneesmiddelen een passage moest worden opgenomen om te waarschuwen dat suïcidaal gedrag (zelfmoordpogingen en zelfmoordgedachten) en vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woede-uitbarstingen) vaker werden waargenomen in klinische onderzoeken onder kinderen en adolescenten die met antidepressiva behandeld werden in vergelijking tot met placebo behandelde jonge patiënten.
Danish: - CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Dutch: Litouwen Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Danish: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Dutch: Nederland KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Danish: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Dutch: Denemarken 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
Dutch: Overwegende dat - het CHMP de verwijzing heeft beoordeeld, ingediend krachtens artikel 31 van Richtlijn 2001/83/EG, als gewijzigd, met betrekking tot atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine bevattende geneesmiddelen;
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.
Dutch: 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
Dutch: Noorwegen Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Danish: Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Dutch: Capsule,hard
Danish: Kapsel, hård
Dutch: Nederland Pharmachemie B.V.
Danish: Pharmachemie B.V.
Dutch: Nederland Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Danish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Dutch: Hongarije Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Danish: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Dutch: Litouwen Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Danish: Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Dutch: Denemarken Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Dutch: Frankrijk SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Danish: SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Oostenrijk F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Danish: F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: SpanjeSpanje TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Danish: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Dutch: Oostenrijk Ratiopharm Arzneimittel Vertriebs Ges.m.b.H., Albert Schweitzer-Gasse 3, 1140 Wien, Austria
Danish: Ratiopharm Arzneimittel Vertriebs Ges.m.b.H., Albert Schweitzer-Gasse 3, 1140 Wien, Austria
Dutch: Nederland Alpharma B.V.
Danish: Alpharma B.V.
Dutch: Slowakije Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Danish: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Dutch: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Dutch: 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
Dutch: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Danish: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Dutch: Oostenrijk Interpharm ProduktionsgmbH., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
Danish: Interpharm ProduktionsgmbH., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: Luxemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Danish: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Dutch: Denemarken Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany