natgillin/translations-raw huggingface dataset:
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. 
Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with placebo.
Tyskland STADA GmbH Stadastr. 
STADA GmbH Stadastr.
Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 
Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K. 
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK 
Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK 
Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem 
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Sandoz B.V., Postbus 216, NL-1380 AE Weesp 
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece 
NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece 
PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Tyskland Synthon B.V. 
Synthon B.V.
Hexal AG, Postfach 1263, D-83602 Holzkirchen 
Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece 
NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK 
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240 
Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich 
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece 
FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece 
ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld 
Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK 
Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen 
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece 
NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England 
ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium 
Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen 
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Laboratoires S.M.B. 
S.A. Laboratoires S.M.B.
Grœkenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece 
GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece 
BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece 
PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK 
Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece 
ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland 
Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Entact Orale dråber 
Entact Oral Drops
Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden 
Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
- 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. 
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;
CITALOPRAM, ESCITALOPRAM, ATOMOXETIN, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN (se bilag I) 
CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380 
Aliud Pharma GmbH & Co.KG Postfach 1380
Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269 
Temmler Pharma GmbH & Co.KG Postfach 2269
Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark 
Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland 
Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Tyskland Rodleben Pharma GmbH Postfach 205 
Rodleben Pharma GmbH Postfach 205
Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 
Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Tyskland TAD Pharma GmbH Postfach 720 
TAD Pharma GmbH Postfach 720
Filmovertrukket tablets 
Film-coated tablets
Rue-de-la-Pastorale 26-28 
Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark 
Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany 
Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland 
Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
ICN Polfa Rzeszow, ul. 
Lithuania ICN Polfa Rzeszow, ul.
Danmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL 
Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany 
Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark 
Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK 
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark 
Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK 
Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany 
Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK 
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2 
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Slovenien Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21 
Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway 
Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece 
UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway 
Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee 
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
20 mg/0,5 ml Koncentrat til infusionsvœske, opløsning 
20 mg/0,5 ml Concentrate for solution for infusion
Koncentrat til injektionsvœske til opløsning 
Concentrate for solution for injection
- Med hensyn til atomoxetin, som kun er indiceret til behandling af ADHD, konkluderede udvalget, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression har CHMP anbefalet, at markedsføringstilladelserne for lægemidlerne nævnt i bilag I opretholdes, for hvilke ændringerne af de relevante dele af produktresuméer og indlægssedler er gengivet i henholdsvis bilag III og IV. 
- 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.
Storbritannien Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK 
Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland 
KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK 
Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Grœkenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece 
FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
2, navnlig hvad angår disses brug i den pædiatriske patientgruppe: fluoxetin, fluvoxamin, sertralin, paroxetin, citalopram, escitalopram, atomoxetin, duloxetin, venlafaxin, mianserin, milnacipran, reboxetin og mirtazapin. 
1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine.
IV.I ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN 
IV.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PACKAGE LEAFLET FOR FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Danmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain 
Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Tyskland Neosan Filchnerstr. 
Filchnerstr.
Storbritannien Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK 
Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Storbritannien Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK 
Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK 
John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Grœkenland PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece 
PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Orale dråber, opløsning Oral anvendelse 
Oral Drops, solution Oral use
Tyskland Lundbeck GmbH Postfach 900662 
Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK 
Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K. 
Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Alfred Tiefenbacher (GmbH & Co. 
Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria 
Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Dispergible tablet 
Dispersable tablet
Tyskland F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 
F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Storbritannien Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland 
Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
D-53773 Hennef paroxetin-biomo 20mg 20 mg 
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Orale dråber, opløsning 
Oral drops, solution
Danmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland 
Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Tyskland ct-Arzneimittel GmbH Lengeder Str. 42a 
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Centrafarm Services B.V. 
Netherlands Centrafarm Services B.V. Postbus 289
Grœkenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE 
PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Tyskland Pfizer Pharma GmbH Pfizerstr. 
Pfizer Pharma GmbH Pfizerstr.
D-13407 Berlin paroxetin von ct 20 mg Filmtabletten 
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Storbritannien Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands 
Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Danmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB 
Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Danmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland 
Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK 
Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Storbritannien Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; 
Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Slovenien KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501 
KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia
Danmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany 
Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Danmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland 
Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Danmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220 
Denmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
Danmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB 
Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Danmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB 
Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Danmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220 
Denmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
Sverige ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU) 
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Danmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220 
Denmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
Storbritannien Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland 
Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
Slovenien LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia 
LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia
Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 6XA, United Kingdom 
Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21 6XA, Great Britain
Storbritannien Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK 
Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten 
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Lœgemiddelform Indgivelsesvej 
Pharmaceutical form Route of administration
CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression. 
Therefore the CHMP 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 the relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Danmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France 
Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Dispergible tablets 
Dispersible tablets
Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre 
Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary 
Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten 
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
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. 
The CHMP concluded that a warning to reflect that 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, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
VENLAFAXIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen 
VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Storbritannien H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark 
H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Danmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany 
Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Danmark N.V. 
Denmark N.V. Organon, P.O.
Oral vœske 
Oral soulution
D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten 
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
I.C.C. 
Netherlands I.C.C.
D-53773 Hennef fluoxetin-biomo 20mg Kapseln 
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel 
Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Oral use 
Oropharyngeal use
MIRTAZAPIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsforings tilladelsen 
MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
- 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. 
- The Committee, as a consequence, concluded that a warning to reflect that 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, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
CITALOPRAM indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen 
CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
MILNACIPRAN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen 
MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark 
Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Niche Generics Ltd. 
Generics (UK) Ltd.