FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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.
French: - Le Comité, en conséquence, a conclu qu'une mise en garde rapportant que des comportements de type suicidaire (tentatives de suicide et idées suicidaires) et un comportement hostile (principalement agressivité, comportement d'opposition et colère) avaient été plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités par antidépresseurs par rapport à ceux traités par placebo, devait être incluse dans les Résumés des Caractéristiques du Produit et la rubrique concernée des Notices du Produit des spécialités pharmaceutiques contenant du citalopram, de l'escitalopram, de la fluoxétine, de la fluvoxamine, de la miansérine, du milnacipran, de la mirtazapine, de la paroxétine, de la reboxétine, de la sertraline et de la venlafaxine.
English: Temmler Pharma GmbH & Co.KG Postfach 2269
French: Allemagne Temmler Pharma GmbH & Co.KG Postfach 2269
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)
French: RÉSUMÉ GÉNÉRAL DE L'ÉVALUATION SCIENTIFIQUE DES SPÉCIALITÉS PHARMACEUTIQUES CONTENANT DE LA FLUOXÉTINE, DE LA FLUVOXAMINE, DE LA SERTRALINE, DE LA PAROXÉTINE, DU CITALOPRAM, DE L'ESCITALOPRAM, DE L'ATOMOXÉTINE, DE LA VENLAFAXINE, DE LA MIANSERINE, DU MILNACIPRAN, DE LA REBOXÉTINE ET DE LA MIRTAZAPINE (voir Annexe I)
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.
French: Le CHMP a conclu qu'une mise en garde rapportant que des comportements de type suicidaire (tentative de suicide et idées suicidaires) et de comportement hostile (principalement agressivité, comportement d'opposition et colère) étaient plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités pas antidépresseurs par rapport à ceux traités par placebo, devait être incluse dans les Résumés des Caractéristiques du Produit, ainsi que dans la rubrique concernée des Notices du Produit des spécialités pharmaceutiques contenant du citalopram, de l'escitalopram, de la fluoxétine, de la fluvoxamine, de la miansérine, du milnacipran, de la mirtazapine, de la paroxétine, de la reboxétine, de la sertraline et de la venlafaxine.
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
French: Louisalaan 149/24 B-1050 Brussel, Belgium
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
French: III.I MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DU RCP DES PRODUITS FLUOXÉTINE, FLUVOXAMINE, SERTRALINE, PAROXÉTINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSÉRINE, MILNACIPRAN, REBOXÉTINE ET MIRTAZAPINE
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
French: Danemark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
French: Rue-de-la-Pastorale 26-28
English: Gastro-resistant capsule hard
French: Gélule gastro-résistante Voie orale
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.
French: Par conséquent, le CHMP a conclu qu'une mise en garde rapportant qu'un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle étaient plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités par atomoxétine par rapport à ceux traités par placebo, ainsi qu'une mise en garde indiquant l'absence d'efficacité du produit dans la dépression devaient être incluses dans les Résumés des Caractéristiques du Produit et dans la rubrique concernée des Notices du Produit des spécialités pharmaceutiques contenant de l'atomoxétine.
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: Royaume-Uni Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
French: Danemark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: ORAL SOLUTION
French: Prozit Oral Solution
English: Belgium A.H.P.
French: A.H.P.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
French: Vous devez informer votre médecin si l'un des symptômes énumérés ci-dessus apparaît ou s'aggrave lors de la prise de [Nom de Fantaisie] par un patient de moins de 18 ans. Vous devez également savoir que la sécurité à long terme concernant la croissance, la maturation et le développement cognitif et comportemental de [Nom de Fantaisie] n'a pas encore été établiedans cette tranche d'âge.
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
French: Danemark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
French: Le CHMP a considéré qu'aucun signal d'augmentation du risque de comportement de type suicidaire n'était présent dans les études portant sur l'atomoxétine.
English: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: Royaume-Uni Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
French: Danemark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
French: Danemark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: Royaume-Uni Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
French: Danemark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Concentrate for Solution for Infusion
French: Concentré pour solution buvable
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
French: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
French: Royaume-Uni Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
French: Danemark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Lithuania ICN Polfa Rzeszow, ul.
French: ICN Polfa Rzeszow, ul.
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
French: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
French: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
French: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
French: Royaume-Uni Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
French: KG Elisabeth-Selbert-Str. 1
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
French: Danemark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: 6XA, United Kingdom
French: 8RB, UK
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
French: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
French: Royaume-Uni KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
English: Box 20, Oss, Netherland
French: Organon, P.O. Box 20, Oss, Netherland
English: Box 158 Sköyen N-0212 Oslo Norge (NOR)
French: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
English: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
French: Slovaquie Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
French: Danemark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
French: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
French: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
French: Royaume-Uni Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
French: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
French: Organon , P.O.Box 20, NL - 5340 BH OSS
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
French: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
French: Slovaquie Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
French: Note: Cette notice est celle annexée à la décision de la Commission relative à la saisine communautaire conformément à l'Article 31 de la Directive 2001/83/CE du parlement européen et du conseil..
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
French: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
French: Allemagne ct-Arzneimittel GmbH Lengeder Str. 42a
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
French: Royaume-Uni John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
English: CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
French: VENLAFAXINE, LA MIANSÉRINE, LE MILNACIPRAN, LA REBOXÉTINE ET LA
English: Prolonged release capsule, hard
French: Capsule molle à libération prolongée
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
French: Danemark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
French: Royaume-Uni Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
English: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
French: Royaume-Uni Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Fluneurin 40mg Tabs
French: Fluneurin 40mg Tabs 40 mg
English: Fevarin Tabs 50 mg 50 mg
French: Fevarin Tabs 50 mg
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
French: Royaume-Uni Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
French: Royaume-Uni Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
French: Allemagne F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
French: Alfred Tiefenbacher (GmbH & Co.
English: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
French: Allemagne Lundbeck GmbH Postfach 900662
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
French: Danemark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
English: Netherlands N.V. Organon t.a.v.
French: Organon t.a.v.
English: 20 mg/0,5 ml Concentrate for solution for infusion
French: 20 mg/0,5 ml Solution à diluer pour perfusion
English: Synthon BV, Microweg 22, P.O.
French: Synthon BV, Microweg 22, P.O. Box 7071
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
French: Organon, Postbus 20, NL-5340 BH Oss
English: Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: Royaume-Uni Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Hard Capsules
French: Capsule molle
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
French: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
French: D-53773 Hennef paroxetin-biomo 20mg 20 mg
English: Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
French: Danemark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
English: Netherlands Centrafarm Services B.V. Postbus 289
French: Centrafarm Services B.V.
English: A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000 Fraderiksberg
French: Slovaquie A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
French: Molièrelaan 225 1050 Brussel
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
French: Royaume-Uni Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
French: Molièrelaan 225 1050 Brussel, Belgium
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
French: D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
English: Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
French: Danemark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
English: 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.
French: 1/IRSN suivants : fluoxétine, fluvoxamine, sertraline, paroxétine, citalopram, escitalopram, atomoxétine, duloxétine, venlafaxine, miansérine, milnacipran, reboxétine et mirtazapine, et en particulier concernant leur utilisation chez la population pédiatrique.
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
French: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
French: Royaume-Uni Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
French: Slovaquie EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
English: Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
French: Danemark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
French: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
French: Slovaquie EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
English: Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
French: Royaume-Uni Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
English: Fluneurin 10mg Tabs
French: Fluneurin 10mg Tabs 10 mg
English: Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
French: Danemark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
French: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Fluneurin 20mg Tabs
French: Fluneurin 20mg Tabs 20 mg
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
French: Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
French: Slovaquie Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
English: Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
French: Danemark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
English: Denmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
French: Danemark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
French: Demunterlaan 1 1090 BRUSSEL, Belgium
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
French: Danemark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
French: KG Leipziger Str. 7-13
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
French: Danemark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
English: Wyeth Lederle Pharma GmbH, Storchengasse 1, A- 1150 Wien
French: Slovaquie Wyeth Lederle Pharma GmbH, Storchengasse 1, A- 1150 Wien
English: Denmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
French: Danemark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
English: Denmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
French: Danemark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
English: Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
French: Royaume-Uni Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
English: Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
French: Suède ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
English: LABORATORIOS RUBIO, S.A., Industria 29 - Pol. Ind. Comte de Sert., Castellbisbal 08755, Spain
French: Comte de Sert., Castellbisbal 08755, Spain
English: Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
French: Royaume-Uni Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
French: RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
French: D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
English: Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
French: Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
English: Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
French: Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
English: Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
French: Slovaquie Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
English: Member State Marketing Authorisation Holder Invented Name
French: État Membre Détenteur de l'autorisation de mise sur le marché
English: Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
French: Danemark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
English: Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
French: Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
English: BOX 1161, 89143 BLAUBEUREN, Germany
French: Merckle GmbH, Ludwig-MerckleStrasse 3, P.O. BOX 1161, 89143 BLAUBEUREN, Germany
English: H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
French: Royaume-Uni H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
English: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
French: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
French: Danemark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
French: D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
English: Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
French: Slovaquie Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
English: Prolonged release capsule Oral use
French: Gélule à libération prolongée Voie orale
English: REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
French: Médicaments contenant de la reboxétine ayant une autorisation de mise sur le marché dans l'Union Européenne État Membre Détenteur de l'autorisation de mise sur le marché
English: Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
French: Danemark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
English: MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
French: Médicaments contenant de la mirtazapine ayant une autorisation de mise sur le marché dans l'Union Européenne État Membre Détenteur de l'autorisation de mise sur le marché
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef
French: Allemagne biomo pharma GmbH Josef-Dietzgen-Str. 3
English: Denmark N.V. Organon, P.O.
French: Danemark N.V.
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
French: D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
English: Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
French: Danemark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
French: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Netherlands I.C.C.
French: I.C.C.