FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Dutch: Luxemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Esparma GmbH Postfach 1461
Dutch: Duitsland Esparma GmbH Postfach 1461
English: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Dutch: Frankrijk Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Dutch: Denemarken PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Dutch: Nederland Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Pharmaceutical form Route of administration
Dutch: Farmaceutische vorm Wijze van toediening
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Dutch: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmomhulde tablet
English: GlaxoSmithKline GmbH & Co. KG Theresienhoehe 11
Dutch: Duitsland GlaxoSmithKline GmbH & Co. KG Theresienhoehe 11
English: Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Dutch: Noorwegen Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
English: Ashbourne Industrial Estate Unit 107
Dutch: Frankrijk Pharmascope Ashbourne Industrial Estate Unit 107
English: Neuraxpharm Arzneimittel GmbH & Co.KG
Dutch: Duitsland Neuraxpharm Arzneimittel GmbH & Co.KG
English: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Dutch: Griekenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Dutch: Nederland Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Hormosan-Kwizda GmbH Postfach 600340
Dutch: Duitsland Hormosan-Kwizda GmbH Postfach 600340
English: Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Dutch: Noorwegen Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
English: Krewel Meuselbach GmbH Postfach 1263
Dutch: Duitsland Krewel Meuselbach GmbH Postfach 1263
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Dutch: Nederland Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Dutch: Griekenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Dutch: Nederland Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Dutch: Oostenrijk Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
English: - The Committee, in view of available data from clinical trials, concluded that there is a signal of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
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;
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Dutch: IV.2 IN DE DESBETREFFENDE PARAGRAAF VAN DE BIJLSUITER VOOR ATOMOXETINE OP TE NEMEN WIJZIGINGEN
English: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Dutch: Hongarije Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
English: Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Dutch: Noorwegen Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Dutch: Nederland Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Dutch: Nederland Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Hard Capsules
Dutch: Harde Capsules
English: Arcana Arzneimittel GmbH, Zimbagasse 5, 1147 Wien, Austria
Dutch: Oostenrijk Arcana Arzneimittel GmbH, Zimbagasse 5, 1147 Wien, Austria
English: B.V. Postbus 75
Dutch: Postbus 75
English: Merck dura GmbH Postfach 100635
Dutch: Duitsland Merck dura GmbH Postfach 100635
English: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Dutch: Frankrijk SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Dutch: Nederland Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Dutch: Luxemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Dutch: Denemarken Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
English: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Dutch: Griekenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Dutch: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Solvay Arzneimittel GmbH Postfach 220
Dutch: Duitsland Solvay Arzneimittel GmbH Postfach 220
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Dutch: Nederland Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Sandoz Pharmaceuticals GmbH Dieselstr.
Dutch: Duitsland Sandoz Pharmaceuticals GmbH Dieselstr.
English: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Dutch: Griekenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Dutch: Nederland Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Dutch: Denemarken Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Dutch: Duitsland Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Dutch: Nederland Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Dutch: Denemarken GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria
Dutch: Oostenrijk Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Dutch: Viale Amelia, 70 00181 Roma Italy
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Dutch: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Dutch: Hongarije Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
English: BC Biochemie Pharma GmbH Dieselstr.
Dutch: Duitsland BC Biochemie Pharma GmbH Dieselstr.
English: Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Dutch: Oostenrijk Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Dutch: Denemarken Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
English: Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Dutch: Hongarije Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
English: Boehringer Ingelheim Pharma GmbH & Co.KG
Dutch: Duitsland Boehringer Ingelheim Pharma GmbH & Co.KG
English: LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Dutch: Frankrijk LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Dutch: Nederland Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Lithuania Ranbaxy (UK) Ltd., C.P.
Dutch: Litouwen Ranbaxy (UK) Ltd., C.P.
English: Wyeth Pharma GmbH Postfach 8806
Dutch: Duitsland Wyeth Pharma GmbH Postfach 8806
English: Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Dutch: Oostenrijk Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Dutch: Denemarken Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Dutch: Luxemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Stada Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria
Dutch: Oostenrijk Stada Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Dutch: Denemarken BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Dutch: Rijksweg 12 2870 Puurs, Belgium
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Dutch: Denemarken Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Dutch: Duitsland AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Dutch: Nederland Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Dutch: Nederland Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Dutch: Griekenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
English: Diagonal, 507, 08029 Barcelona, Spain
Dutch: Diagonal, 507, 08029 Barcelona, Spanje
English: Denmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Dutch: Denemarken Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
English: Frankfurter Str. 129a D-64293 Darmstadt
Dutch: Duitsland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Dutch: Denemarken Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Dutch: Denemarken Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Dutch: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Dutch: Nederland Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Dutch: Nederland Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Dutch: Luxemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: STADA GmbH Stadastr.
Dutch: Duitsland STADA GmbH Stadastr.
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Dutch: Luxemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: WINTHROP médicaments 174 avenue de France 75013 Paris
Dutch: Frankrijk WINTHROP médicaments 174 avenue de France
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Dutch: Nederland Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Dutch: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Dutch: Griekenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
English: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Dutch: Griekenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Dutch: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
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.
English: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Dutch: Noorwegen Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Dutch: Litouwen SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Dutch: Griekenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
English: Pharmacia GmbH Pfizerstr.
Dutch: Duitsland Pharmacia GmbH Pfizerstr.
English: 16, Chemin de Coquelicots CH - 1214 Geneva
Dutch: Slowakije Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
English: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Dutch: Griekenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
English: 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
Dutch: Oostenrijk 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
English: Lithuania MedochemieLtd., p.o. box 51409, Limassol, CY - 3505,
Dutch: Litouwen MedochemieLtd., p.o. box 51409, Limassol, CY - 3505,
English: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
English: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Dutch: Noorwegen IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Dutch: Litouwen Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Dutch: Griekenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Dutch: SNRI staat voor ‘Selective Norepinephrine Re-uptake Inhibitor' (selectieve norepinefrine-heropnameremmer).
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Dutch: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Dutch: Fabrik , Holger Danskaes Vej 89, DK - 2000
English: Belgium BEXAL S.P.R.L.
Dutch: BEXAL S.P.R.L.
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Dutch: Nederland Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Hexal Pharma GmbH, Wilhelmimenstr.
Dutch: Oostenrijk Hexal Pharma GmbH, Wilhelmimenstr.
English: GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Dutch: Griekenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Dutch: Nederland Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Dutch: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Dutch: Litouwen Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Dutch: Frankrijk Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
English: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Dutch: Slowakije Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
English: 13 rue pagès
Dutch: Frankrijk Lilly France 13 rue pagès
English: Solution for infusion Intravenous use
Dutch: Oplossing voor intraveneuze infusie
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Dutch: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: Nederland Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Dutch: Duitsland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Dutch: Nederland KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Dutch: Hongarije Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
English: - For atomoxetine, which is only indicated in the treatment of ADHD, the Committee concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger), and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Dutch: - voor atomoxetine, dat uitsluitend geïndiceerd is voor de behandeling van ADHD, het CHMP concludeerde dat gewaarschuwd moest worden tegen het feit dat vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woede-uitbarstingen) en emotionele labiliteit vaker voorkwamen in klinische onderzoeken onder kinderen en adolescenten die behandeld werden met atomoxetine in vergelijking tot degenen die met placebo behandeld werden en dat een waarschuwing hiervoor moest worden opgenomen in de samenvattingen van de productkenmerken en de relevante rubriek van de bijsluiter van geneesmiddelen die atomoxetine bevatten.
English: S.A. Laboratoires S.M.B.
Dutch: Laboratoires S.M.B.
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Dutch: Denemarken Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Concentrate for oral solution Oral use
Dutch: Concentraat voor oplossing voor oraal gebruik
English: Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Dutch: Oostenrijk Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
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.
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Dutch: Denemarken Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Aliud Pharma GmbH & Co.KG Postfach 1380
Dutch: Duitsland Aliud Pharma GmbH & Co.KG Postfach 1380
English: Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Dutch: Hongarije Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
English: Whereas - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine;
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;
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: Nederland Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Dutch: Luxemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: TAD Pharma GmbH Postfach 720
Dutch: Duitsland TAD Pharma GmbH Postfach 720
English: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Dutch: Oostenrijk GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
English: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Dutch: Duitsland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
English: Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
Dutch: Litouwen Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
English: Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Dutch: Hongarije Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
English: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Dutch: Frankrijk IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Dutch: Litouwen Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
English: 264 Rue du faubourg saint honoré 75008 Paris - France
Dutch: Frankrijk MG PHARMA 264 Rue du faubourg saint honoré 75008 Paris - France
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Dutch: Denemarken Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Dutch: Litouwen Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Dutch: Denemarken NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Dutch: Frankrijk EG Labo laboratoire Eurogenerics le Quintet Batiment A
English: Prolonged-release capsule Oral use
Dutch: Prolonged-release capsule Oraal gebruik
English: Woerwag Pharma GmbH & Co. KG Postfach 2129
Dutch: Duitsland Woerwag Pharma GmbH & Co. KG Postfach 2129
English: Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Dutch: Noorwegen Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
English: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
English: H.Lundbeck A/S Ottiliavej 7-9
Dutch: Duitsland H.Lundbeck A/S Ottiliavej 7-9
English: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Dutch: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Rodleben Pharma GmbH Postfach 205
Dutch: Duitsland Rodleben Pharma GmbH Postfach 205