FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, Luxembourg
Danish: Slovenien Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen,
Dutch: Patiënten jonger dan 18 jaar hebben een verhoogd risico op vijandigheid (voornamelijk agressie, oppositioneel gedrag en woede) en emotionele labiliteit.
Danish: Patienter under 18 år har øget risiko for bivirkninger som f.eks. fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet.
Dutch: Denemarken PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Danish: Danmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Dutch: Nederland Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Danish: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Dutch: Oostenrijk S.Med Handels GmbH, Bräunerstr.
Danish: S.Med Handels GmbH, Bräunerstr.
Dutch: Duitsland S.A. Laboratoires S.M.B.
Danish: Tyskland S.A. Laboratoires S.M.B.
Dutch: Nederland Eli Lilly Nederland BV Postbus 379
Danish: Eli Lilly Nederland BV Postbus 379
Dutch: Duitsland STADA Arzneimittel AG Stadastr.
Danish: Tyskland STADA Arzneimittel AG Stadastr.
Dutch: Griekenland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
Danish: Grœkenland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
Dutch: Luxemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Danish: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Dutch: Nederland Merck Generics BV Dieselweg 25
Danish: Merck Generics BV Dieselweg 25
Dutch: Hongarije IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Danish: IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Dutch: Oostenrijk Alternova Arzneimittel GmbH, Grawatschgasse 4/14,1230 Wien
Danish: Alternova Arzneimittel GmbH, Grawatschgasse 4/14,1230 Wien
Dutch: Hongarije Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Danish: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Dutch: Duitsland AbZ-Pharma Graf-Arco-Str. 3
Danish: Tyskland AbZ-Pharma Graf-Arco-Str. 3
Dutch: Hongarije Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
Danish: Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
Dutch: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Danish: Storbritannien Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Dutch: Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Danish: Storbritannien Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Dutch: Griekenland 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
Dutch: Nederland Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Danish: Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Dutch: Luxemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Danish: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Dutch: Hongarije Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary
Danish: Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary
Dutch: Frankrijk Synthon Bv Microweg 22
Danish: Synthon Bv Microweg 22
Dutch: Noorwegen Alternova AS, Holmengata 24, NO1394 Nesbru, Norway
Danish: Alternova AS, Holmengata 24, NO1394 Nesbru, Norway
Dutch: Griekenland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Danish: Grœkenland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Dutch: Denemarken Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Danish: Danmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Dutch: Litouwen Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Danish: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Dutch: Frankrijk Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Danish: Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Dutch: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Danish: Storbritannien Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Dutch: Hongarije Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100
Danish: Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Dutch: Hongarije Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary
Danish: Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary
Dutch: Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Danish: Storbritannien Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Dutch: Nederland Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Danish: Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Dutch: Oostenrijk Lundbeck Austria GmbH, Dresdner Straße 82, 1200 Wien, Austria
Danish: Lundbeck Austria GmbH, Dresdner Straße 82, 1200 Wien, Austria
Dutch: BIJLAGE IV WIJZIGINGEN VAN DE BIJSLUITER
Danish: BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
Dutch: Griekenland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Danish: Grœkenland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Dutch: Frankrijk ORGANON 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Danish: 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Dutch: Nederland Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Danish: Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Dutch: Nederland Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Danish: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Dutch: REDENEN VOOR DE WIJZIGING VAN DE SAMENVATTINGEN VAN DE PRODUCTKENMERKEN
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE
Dutch: Duitsland Holsten Pharma GmbH Im Buergerstock 7
Danish: Tyskland Holsten Pharma GmbH Im Buergerstock 7
Dutch: Nederland Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Danish: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Dutch: Denemarken Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Danish: Danmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Dutch: Griekenland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Danish: Grœkenland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Dutch: Duitsland PharmaSelect GmbH Am Saegewerk 13
Danish: Tyskland PharmaSelect GmbH Am Saegewerk 13
Dutch: Slowakije GlaxoSmithKline Slovakia s.r.o.
Danish: GlaxoSmithKline Slovakia s.r.o.
Dutch: Duitsland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Danish: Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Dutch: Hongarije Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary
Danish: Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary
Dutch: Duitsland SIEMENS & CO Postfach 1262
Danish: Tyskland SIEMENS & CO Postfach 1262
Dutch: 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
Dutch: Frankrijk BOUCHARA RECORDATI 68 Rue Marjolin
Danish: BOUCHARA RECORDATI 68 Rue Marjolin BP 67
Dutch: Duitsland AAI Deutschland GmbH & Co.KG Wegenerstr.
Danish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
Dutch: Nederland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Danish: Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Dutch: 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
Dutch: Griekenland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Danish: Grœkenland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Dutch: Denemarken Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Danish: Danmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Dutch: 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
Dutch: Nederland GenRx B.V., Postbus 75, NL-6920 AB Duiven
Danish: GenRx B.V., Postbus 75, NL-6920 AB Duiven
Dutch: Luxemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Danish: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Dutch: Hongarije Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Danish: Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Dutch: Griekenland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Danish: Grœkenland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Dutch: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Danish: Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Dutch: Duitsland HEXAL AG Postfach 1263
Danish: Tyskland HEXAL AG Postfach 1263
Dutch: 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
Dutch: Duitsland TEVA Generics GmbH Kandelstr.
Danish: Tyskland TEVA Generics GmbH Kandelstr.
Dutch: Het CHMP was het erover eens dat er sprake was van een potentieel signaal voor een toename van suïcidaal gedrag, met inbegrip van zelfmoordpogingen en zelfmoordneigingen en/of aanverwant gedrag zoals automutilatie, vijandelijkheid en stemmingswisselingen bij kinderen en adolescenten die met SSRI's en SNRI's behandeld worden.
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.
Dutch: Nederland AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Danish: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Dutch: Griekenland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Danish: Grœkenland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Dutch: Duitsland Desitin Arzneimittel GmbH Postfach 630164
Danish: Tyskland Desitin Arzneimittel GmbH Postfach 630164
Dutch: Nederland Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Danish: Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Dutch: Griekenland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Danish: Grœkenland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Dutch: Frankrijk CHIESI 11, avenue Dubonnet 92400 Courbevoie France
Danish: 11, avenue Dubonnet 92400 Courbevoie France
Dutch: SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Danish: Storbritannien SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Dutch: Oostenrijk UCB Pharma Ges.m.b.H., Brünnerstr.
Danish: UCB Pharma Ges.m.b.H., Brünnerstr.
Dutch: Griekenland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Danish: Grœkenland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Dutch: Frankrijk ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Danish: ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Dutch: Griekenland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Danish: Grœkenland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Dutch: 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
Dutch: Intravenous infusion
Danish: Intravenøs infusion
Dutch: Oostenrijk Eli Lilly Ges.m.b.H., Kölblgasse 8-10, 1030 Wien, Austria
Danish: Eli Lilly Ges.m.b.H., Kölblgasse 8-10, 1030 Wien, Austria
Dutch: Duitsland Winthrop Arzneimittel GmbH Industriestr.
Danish: Tyskland Winthrop Arzneimittel GmbH Industriestr.
Dutch: 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
Dutch: Nederland Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Danish: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Dutch: Denemarken Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Danish: Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Dutch: Als uw arts [Fantasienaam] heeft voorgeschreven aan een patiënt die jonger is dan 18 en u wilt dit bespreken, dan wordt u verzocht contact op te nemen met uw arts. Indien bij patiënten jonger dan 18 jaar één van de hiervoor genoemde symptomen zich ontwikkelt of verslechtert bij inname van [Fantasienaam], dan wordt u verzocht uw arts hierover te informeren.
Danish: Hvis din læge har ordineret [særnavn] til en patient under 18 år, og du ønsker at drøfte dette, skal du henvende dig til din læge.
Dutch: Oostenrijk Solvay Pharma Ges.m.b.H., Donaustr.
Danish: Solvay Pharma Ges.m.b.H., Donaustr.
Dutch: Uit de studies naar depressies kwam echter een duidelijk signaal voor een verhoging van suïcidaal gedrag naar voren en uit de studies naar angststoornissen eveneens, zij het minder sterk.
Danish: Der var dog tydelige signaler på selvmordsrelateret adfærd i undersøgelserne af depression og mindre stærke signaler i undersøgelserne af angst.
Dutch: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Danish: Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
Dutch: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Danish: Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Dutch: 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
Dutch: Denemarken Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Danish: Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Dutch: SNRI's werken op de norepinefrine- en serotonineneurotransmitters.
Danish: SNRI påvirker noradrenalin- og serotonin-neurotransmittere
Dutch: Duitsland Juta Pharma GmbH Gutenbergstr.
Danish: Tyskland Juta Pharma GmbH Gutenbergstr.
Dutch: Nederland Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Danish: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Dutch: Nederland Centrafarm Services B.V.
Danish: Centrafarm Services B.V.
Dutch: Denemarken Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Danish: Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Dutch: Nederland Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Danish: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Dutch: APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Danish: Europark Oost 34, 9100 St. Niklaas, Belgium
Dutch: Noorwegen GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
Danish: GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
Dutch: Luxemburg MERCK N.V.
Danish: Luxembourg MERCK N.V.
Dutch: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmomhulde tablet
Danish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmovertrukket tablet
Dutch: MOM Park Gesztenyés torony, 1124
Danish: MOM Park Gesztenyés torony, 1124 Budapest, Hungary
Dutch: Griekenland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Danish: Grœkenland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Dutch: Griekenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Danish: Grœkenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Dutch: Frankrijk Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Danish: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Dutch: Luxemburg SOCOBOM N.V.
Danish: Luxembourg SOCOBOM N.V.
Dutch: Nederland Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Danish: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Dutch: Denemarken PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Danish: Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Dutch: Denemarken 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Danish: Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Dutch: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spanje
Danish: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spain
Dutch: Noorwegen Eli Lilly Norge AS, Grenseveien 99, P.O.Box 6090 Etterstad, NO-0601
Danish: Eli Lilly Norge AS, Grenseveien 99, P.O.Box 6090 Etterstad, NO-0601 Oslo, Norway
Dutch: Cipralex Oral Drops
Danish: Cipralex Orale dråber
Dutch: Duitsland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Danish: Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Dutch: Griekenland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Danish: Grœkenland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Dutch: Luxemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Danish: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Dutch: Griekenland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Danish: Grœkenland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Dutch: Frankrijk Pharmascope Ashbourne Industrial Estate Unit 107
Danish: Ashbourne Industrial Estate Unit 107
Dutch: Noorwegen Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Danish: Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Dutch: Griekenland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Danish: Grœkenland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Dutch: Luxemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Danish: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Dutch: IV.2 IN DE DESBETREFFENDE PARAGRAAF VAN DE BIJLSUITER VOOR ATOMOXETINE OP TE NEMEN WIJZIGINGEN
Danish: IV.2 ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR ATOMOXETIN
Dutch: Noorwegen Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Danish: Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Dutch: Nederland Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Danish: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Dutch: 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
Dutch: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Danish: Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Dutch: Oostenrijk Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Danish: Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Dutch: Duitsland Neuraxpharm Arzneimittel GmbH & Co.KG
Danish: Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG
Dutch: - het CHMP, in het licht van beschikbare gegevens uit klinische studies, van mening was dat er een signaal is voor suïcidaal gedrag, met inbegrip van zelfmoordpogingen en zelfmoordneigingen en/of aanverwant gedrag zoals automutilatie, vijandelijkheid en stemmingswisselingen bij kinderen en adolescenten die behandeld worden met selectieve serotonine-heropnameremmers en selectieve serotonine-norepinefrine-heropnameremmers, zoals de voornoemde geneesmiddelen;
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.
Dutch: Duitsland Esparma GmbH Postfach 1461
Danish: Tyskland Esparma GmbH Postfach 1461
Dutch: Griekenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Danish: Grœkenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Dutch: Hongarije Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Danish: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Dutch: Nederland Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Danish: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Dutch: Noorwegen Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Danish: Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Dutch: Nederland Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Danish: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Dutch: Patiënten jonger dan 18 jaar hebben een verhoogd risico op zelfmoordpogingen, zelfmoordgedachten en vijandigheid (voornamelijk agressie, oppositioneel gedrag en woede) als zij behandeld worden met geneesmiddelen uit deze therapeutische klasse.
Danish: Desuden gøres opmærksom på, at patienter under 18 år har øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de behandles med denne klasse af lægemidler.
Dutch: Nederland Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Danish: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Dutch: Denemarken Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Danish: Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Dutch: Denemarken Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Danish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Dutch: Griekenland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Danish: Grœkenland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Dutch: Duitsland Krewel Meuselbach GmbH Postfach 1263
Danish: Tyskland Krewel Meuselbach GmbH Postfach 1263
Dutch: Oostenrijk Arcana Arzneimittel GmbH, Zimbagasse 5, 1147 Wien, Austria
Danish: Arcana Arzneimittel GmbH, Zimbagasse 5, 1147 Wien, Austria
Dutch: Duitsland BC Biochemie Pharma GmbH Dieselstr.
Danish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
Dutch: Frankrijk SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Danish: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Dutch: Frankrijk RATIOPHARM Graf Arco Strasse 3
Danish: RATIOPHARM Graf Arco Strasse 3
Dutch: Nederland Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Danish: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Dutch: Griekenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Dutch: Luxemburg ORGANON EUROPE N.V.
Danish: Luxembourg ORGANON EUROPE N.V.
Dutch: Luxemburg EUROGENERICS N.V.
Danish: Luxembourg EUROGENERICS N.V.
Dutch: Litouwen Pharmaceutical Works Polpharma S.A., ul.
Danish: Pharmaceutical Works Polpharma S.A., ul.
Dutch: Nederland Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Dutch: Denemarken N.V.
Danish: Danmark N.V.
Dutch: Nederland Katwijk Farma B.V.
Danish: Katwijk Farma B.V.
Dutch: Oostenrijk Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria
Danish: Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria
Dutch: Frankrijk LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
Danish: LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Dutch: Duitsland Lundbeck GmbH Postfach 900662
Danish: Tyskland Lundbeck GmbH Postfach 900662
Dutch: Hongarije Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Danish: Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Dutch: Hongarije Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Danish: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary