FrancophonIA/ELRC3.0 huggingface dataset:
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Italian: Regno Unito Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: Via A. Fleming, 2 37135 Verona Italy
Italian: Glaxosmithkline S.p.A. Via A. Fleming, 2 37135 Verona Italy
English: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Italian: Portogallo Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Italian: III.2 MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO PER ATOMOXETINA
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Italian: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: H.Lundbeck A/S Ottiliavej 7-9
Italian: Germania H.Lundbeck A/S Ottiliavej 7-9
English: Temmler Pharma GmbH & Co.KG Postfach 2269
Italian: Germania Temmler Pharma GmbH & Co.KG Postfach 2269
English: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Italian: Portogallo Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Italian: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Italian: 2696-901 Bobadela Portugal
English: Belgium A.H.P.
Italian: A.H.P.
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Italian: Rue-de-la-Pastorale 26-28
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: Danimarca Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: 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)
Italian: RIASSUNTO GENERALE DELLA VALUTAZIONE SCIENTIFICA DEI MEDICINALI CONTENENTI FLUOXETINA, FLUVOXAMINA, SETRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, ATOMOXETINA, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA (cfr. allegato I)
English: Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Italian: Portogallo Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Italian: Regno Unito Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Via G. Richard, 7 20143 Milano Italy
Italian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
English: Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Italian: Danimarca Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
English: Viale Monza, 20 20128 Milano Italy
Italian: Ratiopharm Italia S.r.l. Viale Monza, 20 20128 Milano Italy
English: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Regno Unito Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: Danimarca Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Italian: Danimarca Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Italian: Danimarca Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Italian: Portogallo Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
English: 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
Italian: III.I MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO DI FLUOXETINA, FLUVOXAMINA, SERTRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA
English: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Regno Unito Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: Danimarca Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Italian: Portogallo Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Italian: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Italian: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Italian: Regno Unito Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
English: Lithuania ICN Polfa Rzeszow, ul.
Italian: ICN Polfa Rzeszow, ul.
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Italian: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Italian: Portogallo Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: Danimarca Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Italian: Regno Unito Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Italian: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Italian: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Italian: KG Elisabeth-Selbert-Str. 1
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.
Italian: - che il comitato, per quanto concerne l'atomoxetina indicata solo per il trattamento di ADHD, ha concluso che nei riassunti delle caratteristiche dei prodotti e nei relativi foglietti illustrativi dei prodotti contenenti atomoxetina venga integrato un avvertimento concernente l'ostilità (essenzialmente aggressività, comportamento di opposizione e collera) e predisposizione emotiva frequentemente osservate negli studi clinici relativi a bambini e adolescenti trattati con atomexitina rispetto a quelli trattati con placebo nonché un avvertimento che indichi la mancanza di efficacia nella depressione.
English: 6XA, United Kingdom
Italian: 8RB, UK
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Italian: Danimarca Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Italian: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Italian: Portogallo Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
English: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Italian: Regno Unito KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
English: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Italian: Portogallo Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Italian: Danimarca Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Italian: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Italian: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Italian: Organon , P.O.Box 20, NL - 5340 BH OSS
English: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Italian: Slovacchia Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Italian: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Italian: Regno Unito Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Italian: Slovacchia Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
English: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Italian: Slovacchia Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
English: Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131 Algés Portugal
Italian: Portogallo Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Italian: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Filchnerstr.
Italian: Germania Neosan Filchnerstr.
English: Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal
Italian: Portogallo Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
English: Via Della Libertà, 30 10095 Grugliasco - Torino Italy
Italian: Solvay Pharma S.p.A. Via Della Libertà, 30 10095 Grugliasco - Torino Italy
English: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Italian: Germania Lundbeck GmbH Postfach 900662
English: Netherlands N.V. Organon t.a.v.
Italian: Organon t.a.v.
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Italian: Germania ct-Arzneimittel GmbH Lengeder Str. 42a
English: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Italian: Regno Unito Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Italian: Danimarca Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Italian: Germania F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
English: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Italian: Regno Unito Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Italian: Regno Unito John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
English: Fevarin Tabs 50 mg 50 mg
Italian: Fevarin Tabs 50 mg
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Italian: Regno Unito Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
English: Zentiva a.s., U Kabelovny 130, Dolní Mecholupy , CZ - 102 37 Praha 10
Italian: Slovacchia Zentiva a.s., U Kabelovny 130, Dolní Mecholupy , CZ - 102 37 Praha 10
English: GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria
Italian: Slovacchia GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Italian: Regno Unito Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
English: Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131 Algés Portugal
Italian: Portogallo Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Italian: Alfred Tiefenbacher (GmbH & Co.
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Italian: Lussemburgo DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Italian: Organon, Postbus 20, NL-5340 BH Oss
English: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Italian: Lussemburgo H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
English: Via Ripamonti, 89 20141 Milano Italy
Italian: Schering Plough S.p.A. Via Ripamonti, 89 20141 Milano Italy
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Italian: Danimarca Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
English: Euro-Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
Italian: Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
English: Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338 Prior Velho Portugal
Italian: Portogallo Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
English: Glaxosmithkline S.p.A.
Italian: GlaxoSmithKline B.V.
English: Prolonged release capsule Oral use
Italian: Capsula a rilascio prolungato Via orale
English: Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Italian: Regno Unito Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Oral solution, single dose Oral use
Italian: Soluzione orale, monodose Via orale
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Italian: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Italian: D-53773 Hennef paroxetin-biomo 20mg 20 mg
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
Italian: Molièrelaan 225 1050 Brussel
English: Netherlands Centrafarm Services B.V. Postbus 289
Italian: Centrafarm Services B.V.
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
Italian: Molièrelaan 225 1050 Brussel, Belgium
English: Modified-release tablet capsule Oral use
Italian: Capsula a rilascio modificato Via orale
English: Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Italian: Danimarca Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Italian: D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Italian: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Italian: Regno Unito Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Italian: Danimarca Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
English: A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000 Fraderiksberg
Italian: Slovacchia A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000
English: Interfarma, Produtos Químicos e Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131 Algés Portugal
Italian: Portogallo Interfarma, Produtos Químicos e Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131 Algés Portugal
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Italian: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Stada Arzneimittel A.G., Stadastrasse 2-18 D-61118 Bad Vilbel Alemanha
Italian: Portogallo Stada Arzneimittel A.G., Stadastrasse 2-18 D-61118 Bad Vilbel Alemanha
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Italian: Regno Unito Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Generics[UK] Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL
Italian: Slovacchia Generics[UK] Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL
English: Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Italian: Danimarca Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
English: 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.
Italian: Il CHMP ha pertanto concluso che nei riassunti delle caratteristiche dei prodotti e nei relativi foglietti illustrativi dei prodotti contenenti atomoxetina venga integrato un avvertimento concernente l'ostilità (essenzialmente aggressività, comportamento di opposizione e collera) e predisposizione emotiva frequentemente osservate negli studi clinici relativi a bambini e adolescenti trattati con atomexitina rispetto a quelli trattati con placebo nonché un avvertimento che indichi la mancanza di efficacia nella depressione
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
Italian: Slovacchia EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
English: Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Italian: Lussemburgo PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
English: Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
Italian: Slovacchia Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Italian: KG Leipziger Str. 7-13
English: Instituto Luso-Fármaco, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131 Algés Portugal
Italian: Portogallo Instituto Luso-Fármaco, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
English: Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Italian: Regno Unito Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
English: Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Italian: Danimarca Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Italian: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
Italian: Slovacchia EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
English: GlaxoSmithkline Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 3 - ArquiparqueMiraflores 1495-131 Algés Portugal
Italian: Portogallo GlaxoSmithkline Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 3 - ArquiparqueMiraflores 1495-131 Algés Portugal
English: Lilly Farma - Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 4 - Piso 3 - ArquiparqueMiraflores 1495-131 Algés Portugal
Italian: Portogallo Lilly Farma - Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 4 - Piso 3 - ArquiparqueMiraflores 1495-131 Algés Portugal
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
Italian: RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
English: Denmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
Italian: Danimarca Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
English: 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.
Italian: Il CHMP ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con placebo.
English: AlenFarma - Especialidades Farmacêuticas, Lda., Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131 Algés Portugal
Italian: Portogallo AlenFarma - Especialidades Farmacêuticas, Lda., Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131 Algés Portugal
English: Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Italian: Danimarca Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Italian: Demunterlaan 1 1090 BRUSSEL, Belgium
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Italian: Danimarca Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
English: Gastro-resistant capsule, hard
Italian: Capsula rigida, gastro resistente
English: Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
Italian: Slovacchia Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
English: Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Italian: Lussemburgo RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Italian: Danimarca Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
English: Denmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
Italian: Danimarca Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
English: Denmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
Italian: Danimarca Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220