natgillin/translations-raw huggingface dataset:
Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium 
Demunterlaan 1 b 9, 1090 Brussel, Belgium
Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 
PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
37 avenue Pierre Premier de Serbie 75008 Paris- France 
Prantsusmaa Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris- France
Netherlands Centrafarm Services B.V. Postbus 289 
Centrafarm Services B.V.
Prolonged release capsule, hard 
Toimeainet prolongeeritult vabastav kapsel
Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel 
Molièrelaan 225 1050 Brussel
BAYVIT, S.A., Frederic Mompou, 5, 08960 Sant Just Desvern, Spain 
Hispaania BAYVIT, S.A., Frederic Mompou, 5, 08960 Sant Just Desvern, Spain
Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium 
Molièrelaan 225 1050 Brussel, Belgium
Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium 
SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
49 Avenue Georges Pompidou 92300 Levallois Perret - France 
Prantsusmaa SANDOZ 49 Avenue Georges Pompidou 92300 Levallois Perret - France
49, avenue Georges Pompidou 92300 Levallois-Perret France 
Prantsusmaa Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
Dispersible tablets 
Dispergeeritav tabletts
49 avenue Georges Pompidou 92300 Levallois-Perret France 
Prantsusmaa SANDOZ 49 avenue Georges Pompidou 92300 Levallois-Perret France
Concentrate for solution for injection 
Kontsentraat infusioonilahuse valmistamiseks
6XA, United Kingdom 
1AG; UK
Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France 
Luksemburg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK 
Ühendkuningriik Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
Modified-release tablet capsule Oral use 
Toimeainet modifitseeritult vabastav tablett, kapsel
III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE 
III.2 ATOMOKSETIINI RAVIMI OMADUSTE KOKKUVÕTTE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
Fluneurin 10mg Tabs 
Fluneurin 10mg Tabs 10 mg
Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK 
Ühendkuningriik Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France 
93300 aubervilliers - France
Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium 
DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands 
Ühendkuningriik Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
37 avenue Pierre Premier de Serbie 75008 Paris -france 
Prantsusmaa Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris -france
Fluneurin 20mg Tabs 
Fluneurin 20mg Tabs 20 mg
Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium 
Demunterlaan 1 1090 BRUSSEL, Belgium
Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain 
Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad REBOKSETIINI sisaldavad ravimid
Luxembourg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany 
Luksemburg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU) 
Rootsi ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland 
Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex 
Slovakkia Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria 
Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria 
Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Luxembourg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium 
Luksemburg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium
Luxembourg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium 
Luksemburg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
- 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. 
- komitee otsustas, et atomoksetiini, mis on näidustatud ainult tähelepanu defitsiidi ja hüperaktiivsuse häire raviks, sisaldavate preparaatide ravimi omaduste kokkuvõttesse ning pakendi infolehte tuleb lisada ravimi nõrgale antidepressiivsele toimele viitav märge ja hoiatus, mis näitaks, et kliinilistes katsetes esines atomoksetiini saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikkust (peamiselt vägivaldsust, vastandavat käitumist ja viha) ja emotsionaalset labiilsust;
Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland 
Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia 
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK 
Ühendkuningriik Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland 
Ühendkuningriik Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
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 otsustas, et estsitalopraami, fluoksetiini, fluvoksamiini, mianseriini, milnatsipraani, mirtasapiini, paroksetiini, reboksetiini, sertraliini, tsitalopraami ja venlafaksiini sisaldavate preparaatide ravimi omaduste kokkuvõtetesse ning pakendi infolehtedesse tuleb lisada hoiatus, mis näitaks, et kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha).
Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium 
Luksemburg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium 
Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium 
Luksemburg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
AWD.pharma GmbH & Co. KG Leipziger Str. 7-13 
KG Leipziger Str. 7-13
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln 
Saksamaa biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium 
EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary 
Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles 
Rue St. Lambert 141 1200 Bruxelles
MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad MILNATSIPRAANI sisaldavad ravimid
H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark 
Ühendkuningriik H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten 
Saksamaa biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500 
H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Luxembourg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium 
Luksemburg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland 
Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany 
Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB 
Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
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. 
Kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha).
Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel 
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB 
Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Oropharyngeal use 
Manustamisviis
Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB 
Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Netherlands I.C.C. 
I.C.C.
Belgium RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium 
Rue St. Lambert 141, 1200 Bruxelles, Belgium
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. 
Seetõttu otsustas CHMP, et atomoksetiini sisaldavate preparaatide ravimi omaduste kokkuvõttesse ning pakendi infolehte tuleb lisada ravimi nõrgale antidepressiivsele toimele viitav märge ja hoiatus, mis näitaks, et kliinilistes katsetes esines atomoksetiini saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikku käitumist (peamiselt vägivaldsust, vastanduvat käitumist ja viha) ning emotsionaalset labiilsust.
Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium 
Rue de l'Etuve 52 1000 Bruxelles, Belgium
Lithuania Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands 
Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
- 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. 
- eeltoodule tuginedes otsustas komitee, et estsitalopraami, fluoksetiini, fluvoksamiini, mianseriini, minatsipraani, mirtasapiini, paroksetiini, reboksetiini, sertraliini, tsitalopraami ja venflafaksiini sisaldavate preparaatide ravimi omaduste kokkuvõtetesse ning pakendi infolehtedesse tuleb lisada hoiatus, mis näitaks, et kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha);
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. 
2-de kohta käivaid siseriiklikele pädevatele organisatsioonidele kättesaadavate kliiniliste uuringute andmeid põhiliselt nende preparaatide pediaatrilise kasutuse seisukohast lähtuvalt: fluoksetiin, fluvoksamiin, sertraliin, paroksetiin, tsitalopraam, estsitalopraam, atomoksetiin, venlafaksiin, mianseriin, milnatsipraan, reboksetiin ja mirtasapiin.
ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad ATOMOKSETIINI sisaldavad ravimid
Luxembourg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany 
Luksemburg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
Belgium RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium 
Rue St, Lambert 141 1200 BRUXELLES, Belgium
Netherlands Katwijk Farma B.V. Postbus 408 
Katwijk Farma B.V.
Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre 
HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Belgium MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium 
MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain 
Hispaania COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
CZECH REPUBLIC 
Tšehhi
Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia 
KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany 
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia 
KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France 
Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
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.1 FLUOKSETIINI, FLUVOKSAMIINI, SERTRALIINI, PAROKSETIINI, TSITALOPRAAMI, ESTSITALOPRAAMI, VENLAFAKSIINI, MIANSERIINI, MILNATSIPRAANI, REBOKSETIINI JA MIRTASAPIINI PAKENDI INFOLEHTEDE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
Netherlands Niche Generics Ltd. 1 The Cam Centre 
Niche Generics Ltd.
Luxembourg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany 
Luksemburg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby 
H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Alfred E Tiefenbacher (GmbH & Co. KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU) 
KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Belgium MERCK N.V. Brusselsesteenweg 288 3090 Overijse 
Brusselsesteenweg 288 3090 Overijse
Oral lyophilisate 
Peroraalne lüofilisaat
Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France 
Prantsusmaa Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France
VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad VENLAFAKSIINI sisaldavad ravimid
FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad FLUOKSETIINI sisaldavad ravimid
MERCK GENERICOS, S.L , CTRA.N-152,Km 19 - Pol. MERCK 08100 Mollet del Valles, Spain 
Hispaania MERCK GENERICOS, S.L , CTRA.N-152,Km 19 - Pol. MERCK 08100 Mollet del Valles, Spain
DOBUPAL RETARD 75 mg hard Capsules 
DOBUPAL RETARD 75 mg
Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K. 
Ühendkuningriik Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Tablets 
Kihisev tablett
Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France 
Prantsusmaa Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France
Belgium AKTUAPHARMA N.V. Ambachtenlaan 13, 3001 Heverlee, Belgium 
Ambachtenlaan 13, 3001 Heverlee, Belgium
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. 
Kliinilistes katsetes esines [ravimi nimetus, osastavas käändes] saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikku käitumist (peamiselt vägivaldsust, vastanduvat käitumist ja viha) ja emotsionaalset labiilsust.
Film-coateds tablet 
Õhukese polümeerkilega kaetud tabletts
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K. 
Ühendkuningriik Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad SERTRALIINI sisaldavad ravimid
Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 Brussel 
Heizel Esplanade B 22 1020 Brussel
Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark 
Ühendkuningriik Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Oral solution, single dose Oral use 
Peroraalne lahus, üksik annus
Prolonged release capsule Oral use 
Toimeainet prolongeeritult vabastav pehmekapsel
Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark 
Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark 
Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
RIMAFAR, S.L., Pol. Ind. Malpica Calle C, Nº 4, 50016 Zaragoza, Spain 
Hispaania RIMAFAR, S.L., Pol. Ind. Malpica Calle C, Nº 4, 50016 Zaragoza, Spain
Belgium TEVA PHARMA BELGIUM N.V. Laarstraat 16, 2610 WILRIJK, Belgium 
Laarstraat 16, 2610 WILRIJK, Belgium
Denmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark 
Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain 
Hispaania BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain
Belgium MERCK N.V. Brusselsesteenweg 288 3090 OVERIJSE, Belgium 
Brusselsesteenweg 288 3090 OVERIJSE, Belgium
Cipramil 40 mg/ml, drops oral drops, solution Oral use 
Cipramil 40 mg/ml, drops
Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany 
Ühendkuningriik Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
ALFRED E. TIEFENBACHER (GMBH & CO. KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany 
KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08 France 
Prantsusmaa Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08
Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl 
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad FLUVOKSAMIINI sisaldavad ravimid
Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08 France 
Prantsusmaa Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08
Denmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany 
Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Euroopa Liidus müügiluba omavad TSITALOPRAAMI sisaldavad ravimid
Luxembourg EUROGENERICS N.V. Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium 
Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
Modified-release capsule, hard Oral use 
Toimeainet modifitseeritult vabastav kõvakapsel
Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 
Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 6XA, United Kingdom
G Gam 
KG)
Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark 
H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Eli Lilly and Company Ltd. Kingsclere Road, Basingstocke RG216XA Hampshire, UK 
Kingsclere Road, Basingstocke RG216XA Hampshire, UK
SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013 Barcelona, Spain 
Hispaania SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013
Denmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany 
Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Netherlands GlaxoSmithKline B.V. Postbus 780 
GlaxoSmithKline B.V.
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten 
D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten 
D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Prolonged releasecapsule, hard Oral use 
Toimeainet prolongeeritult vabastav kõvakapsel
Alfred E. Tiefenbacher GmbH & Co. KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany 
KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
Netherlands GenRx B.V. Postbus 75 
GenRx B.V.
Meat and offal: cattle: 22 days. 
Veis: 22 päeva
Subcutaneous use Vial (glass) 500 ml 
100 mg/ml Süstelahus Veis
Target species 
Subkutaanne manustamine
E-mail info@ema.europa.eu Website www.ema.europa.eu 
E-mail info@ema.europa.eu Websie www.ea.europa.eu
This summary was last updated on 14/03/2011. 
Kokkuvõtte viimane uuendus: 14/03/2011.
These reactions resolve spontaneously within two days to two weeks. 
Need reaktsioonid mööduvad iseenesest 2 päeva kuni 2 nädala jooksul.
The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011. 
Euroopa Komisjon andis CaniLeishi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Virbac S.A. 14/03/2011.
The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended. 
Juba infektsiooni saanud koerte vaktsineerimise efektiivsust ei uuritud ja seetõttu ei saa seda soovitada.
The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one. 
Esimene süst tehakse alates 6 kuu vanusest, teine 3 nädalat pärast esimest ja kolmas 3 nädalat pärast teist süsti.
The vaccine was generally well tolerated as shown by the absence of major adverse reactions. 
Vaktsiini taluti üldiselt hästi, mida näitab peamiste kõrvalnähtude puudumine.