natgillin/translations-raw huggingface dataset:
GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece 
Grekland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Merck dura GmbH Postfach 100635 
Tyskland Merck dura GmbH Postfach 100635
Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland 
Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark 
Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Fluoxetin „Lilly“ 20mglösliche Tabletten 
Fluoxetin „Lilly“ 20mglösliche Tablettten
Sandoz Pharmaceuticals GmbH Dieselstr. 
Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece 
Grekland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Solvay Arzneimittel GmbH Postfach 220 
Tyskland Solvay Arzneimittel GmbH Postfach 220
Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands 
Nederländerna Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark 
Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Wyeth-Lederle Pharma GmbH, Storchengasse 1 
Lettland Wyeth-Lederle Pharma GmbH, Storchengasse 1
Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn 
Nederländerna Alpharma B.V., Postbus 313, NL-3740 AH Baarn
LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris 
Frankrike LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden 
Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Juta Pharma GmbH Gutenbergstr. 
Tyskland Juta Pharma GmbH Gutenbergstr.
Pharmacia GmbH Pfizerstr. 
Tyskland Pharmacia GmbH Pfizerstr.
IIP-Institut fuer industrielle Pharmazie Benzstr. 
Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany 
Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K. 
Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Egis Pharmaceuticals, Kereszturi ut H-1106 Budapest 
Lettland Egis Pharmaceuticals, Kereszturi ut H-1106 Budapest
Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld 
Nederländerna Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden 
Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands 
Nederländerna Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Gedeon Richter LTD, Gyomroi 19-21 
Lettland Gedeon Richter LTD, Gyomroi 19-21
Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK 
Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1 
Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK 
Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Denmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435 
Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden 
Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Heumann Pharma GmbH & Co. Generica KG 
Tyskland Heumann Pharma GmbH & Co. Generica KG
NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece 
Grekland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece 
Grekland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
BC Biochemie Pharma GmbH Dieselstr. 
Tyskland BC Biochemie Pharma GmbH Dieselstr.
Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark 
Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece 
Grekland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Boehringer Ingelheim Pharma GmbH & Co.KG 
Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam 
Nederländerna Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
16, Chemin de Coquelicots CH - 1214 Geneva 
Slovakien Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Wyeth Pharma GmbH Postfach 8806 
Tyskland Wyeth Pharma GmbH Postfach 8806
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten 
Nederländerna Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
SNRIs work on the norepinephrine and serotonin neurotransmitters 
SNRI-produkter påverkar norepinefrin- och serotoninneurotransmittorerna.
Frankfurter Str. 129a D-64293 Darmstadt 
Tyskland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
STADA GmbH Stadastr. 
Tyskland STADA GmbH Stadastr.
- 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. 
- För atomoxetin, som indikeras endast vid behandling av ADHD, ansåg kommittén att en varning som återspeglar att ökad fientlighet (främst aggression, trots och ilska) och emotionell instabilitet observerats i större omfattning vid kliniska försök på barn och ungdomar som behandlades med atomoxetin jämfört med de som behandlades med placebo och att en varning om att läkemedlet inte har någon effekt vid depression skall ingå i produktresuméerna och den relevanta delen i bipacksedlar för läkemedel som innehåller atomoxetin.
ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece 
Grekland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
WINTHROP médicaments 174 avenue de France 75013 Paris 
Frankrike WINTHROP médicaments 174 avenue de France
Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp 
Nederländerna Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece 
Grekland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia 
Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
RANBAXY (UK) LTD., EALING, LONDON 
Tjeckien RANBAXY (UK) LTD., EALING, LONDON
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K. 
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Capsule,hard 
Kapsel, hård
Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom 
Nederländerna Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK 
Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK 
Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Chemical Works of Gedeon Richter Ltd, Gyömrői út 19-21 
Lettland Chemical Works of Gedeon Richter Ltd, Gyömrői út 19-21
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich 
Nederländerna Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece 
Grekland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Stadapharm GmbH Stadastr. 
Tyskland Stadapharm GmbH Stadastr.
Pierre Fabre Medicament, Place Abel Gance 45 
Lettland Pierre Fabre Medicament, Place Abel Gance 45
NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece 
Grekland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK 
Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Hennig Arzneimittel GmbH & Co.KG Postfach 1240 
Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg 
Fabrik , Holger Danskaes Vej 89, DK - 2000
SANDOZ GMBH, KUNDL Biochemiestrasse 10 
Tjeckien SANDOZ GMBH, KUNDL Biochemiestrasse 10
ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece 
Grekland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK 
Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp 
Nederländerna Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem 
Nederländerna Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy 
Slovakien Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece 
Grekland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France 
Frankrike Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK 
StorbritannienA Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
13 rue pagès 
Frankrike Lilly France 13 rue pagès
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2 
Nederländerna KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
20 mg/0,5 ml Concentrate for solution for infusion 
20 mg/0,5 ml Koncentrat till infusionsvätska, lösning
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen 
Nederländerna Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland 
Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK 
Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden 
Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Netherlands Alfred Tiefenbacher (GmbH & Co. KG) 
Nederländerna Alfred Tiefenbacher (GmbH & Co.
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. 
CHMP drog därför slutsatsen att en varning som återspeglar att ökad fientlighet (främst aggression, trots och ilska) och emotionell instabilitet observerats i större omfattning vid kliniska försök på barn och ungdomar som behandlades med atomoxetin jämfört med de som behandlades med placebo och en varning om att läkemedlet inte har någon effekt vid depression skall ingå i produktresuméerna och den relevanta delen i bipacksedlarna för läkemedel som innehåller atomoxetin.
Aliud Pharma GmbH & Co.KG Postfach 1380 
Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07 
Tjeckien HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07
15 boulevard Charles de Gaulle 92707 Colombes cedex - France 
Frankrike Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen 
Nederländerna Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Temmler Pharma GmbH & Co.KG Postfach 2269 
Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
- 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. 
- Till följd härav slog kommittén fast att självmordsrelaterat beteende (självmordsförsök och självmordstankar) och fientlighet (främst aggression, trots och ilska) observerades i högre grad vid kliniska försök på barn och ungdomar som behandlades med antidepressiver jämfört med de som behandlades med placebo, och att en varning för detta skall ingå i produktresuméerna och i den relevanta delen av bipacksedlarna för läkemedel som innehåller citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark 
Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
15 boulevard Charles de Gaulle 92707 Colombes cedex- France 
Frankrike Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
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; 
Med beaktande av följande: - Kommittén beaktade det hänskjutande som gjorts enligt artikel 31 i direktiv 2001/83/EG, i dess senaste lydelse, för läkemedel som innehåller atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
264 Rue du faubourg saint honoré 75008 Paris - France 
Frankrike MG PHARMA 264 Rue du faubourg saint honoré 75008 Paris - France
15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax 
Frankrike IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland 
Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Rodleben Pharma GmbH Postfach 205 
Tyskland Rodleben Pharma GmbH Postfach 205
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. 
CHMP slog fast att självmordsrelaterat beteende (självmordsförsök och självmordstankar) och fientlighet (främst aggression, trots och ilska) observerades i högre grad vid kliniska försök på barn och ungdomar som behandlades med antidepressiver jämfört med de som behandlades med placebo, och att en varning för detta skall ingå i produktresuméerna och i den relevanta delen av bipacksedlarna för läkemedel som innehåller citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou 
Frankrike EG Labo laboratoire Eurogenerics le Quintet Batiment A
ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic 
Tjeckien ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
TAD Pharma GmbH Postfach 720 
Tyskland TAD Pharma GmbH Postfach 720
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, ATOMOXETINE, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE (see Annex I) 
ÖVERGRIPANDE SAMMANFATTNING AV DEN VETENSKAPLIGA UTVÄRDERINGEN AV LÄKEMEDEL SOM INNEHÅLLER FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, ATOMOXETIN, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OCH MIRTAZAPIN (se bilaga 1)
Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark 
Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France 
Frankrike GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK 
Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland 
Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany 
Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
H.Lundbeck A/S Ottiliavej 7-9 
Tyskland H.Lundbeck A/S Ottiliavej 7-9
PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France 
Frankrike PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Modified Release Capsule, hard 
Kapsel med modifierad frisättning, hård
KRKA, Marješka cesta 6 Sl - 8501 Novo mesto SLOVENIA 
Lettland KRKA, Marješka cesta 6 Sl - 8501 Novo mesto SLOVENIA
Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany 
Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL 
Danmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK 
Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark 
Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece 
Grekland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated. 
De långsiktiga effekterna på tillväxt, mognad samt kognitiv och beteendemässig utveckling har ännu inte fastställts för barn och ungdomar under 18 år.
Fluctine 20mg-lösliche Tabletten 
Fluctine 20mg-lösliche Tablettten
Film-coated tablets 
Filmdragerad tabletts
Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark 
Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK 
Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY 
Tjeckien LICHTENSTEIN PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France 
Frankrike SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece 
Grekland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK 
Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto 
Slovakien Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany 
Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 
Slovenien Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21
Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA 
Lettland Zentiva a.s., Nitrianska 100 92027 Hlohovec
Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway 
Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
GENERICS UK LIMITED, CLOSE POTTERS BAR, HERTS, Albany Gate, Darkes Lane, EN6 1AG Potters bar, Herefordshire, UK 
Tjeckien GENERICS UK LIMITED, CLOSE POTTERS BAR, HERTS, Albany Gate, Darkes Lane, EN6 1AG Potters bar, Herefordshire, UK
RANBAXY (UK) LTD., EALING, LONDON, Park Lane 95, W1Y 3TA, Mayfair, London, UK 
Tjeckien RANBAXY (UK) LTD., EALING, LONDON, Park Lane 95, W1Y 3TA, Mayfair, London, UK
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 
IV.I ÄNDRINGAR SOM SKALL FÖRAS IN I DEN RELEVANTA DELEN AV BIPACKSEDELN FÖR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OCH MIRTAZAPIN
Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway 
Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
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. 
I kliniska studier förekom fientlighet (främst aggression, trots och ilska) och emotionell labilitet mer frekvent hos barn och ungdomar som behandlades med [Fantasinamn] än hos dem som behandlades med placebo.
Modified-release tablet capsule Oral use 
Munsönderfallande tablett Oral användning
Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK 
Storbritannien Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland 
Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Netherlands Centrafarm Services B.V. Postbus 289 
Nederländerna Centrafarm Services B.V.
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee 
Nederländerna Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien 
Slovakien Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK 
Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
MEDOCHEMIE LTD., LIMASSOL, Constantinoupoleos St. 1-10, P.O.Box 51409, 3505 Limassol, Cyprus 
Tjeckien MEDOCHEMIE LTD., LIMASSOL, Constantinoupoleos St. 1-10, P.O.Box 51409, 3505 Limassol, Cyprus
Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest 
Slovakien Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Oral Drops, solution Oral use 
Orala droppar, lösning Oral användning