FrancophonIA/ELRC3.0 huggingface dataset:
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Danish: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Danish: Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: TAD Pharma GmbH Postfach 720
Danish: Tyskland TAD Pharma GmbH Postfach 720
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Danish: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Film-coated tablets
Danish: Filmovertrukket tablets
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Danish: Rue-de-la-Pastorale 26-28
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Danish: Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Danish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Lithuania ICN Polfa Rzeszow, ul.
Danish: ICN Polfa Rzeszow, ul.
English: Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Danish: Danmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
English: Belgium A.H.P.
Danish: A.H.P.
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Danish: Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Danish: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Danish: Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Danish: KG Elisabeth-Selbert-Str. 1
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Danish: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
Danish: Slovenien Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Danish: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Danish: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Danish: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danish: Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
English: Box 20, Oss, Netherland
Danish: Organon, P.O. Box 20, Oss, Netherland
English: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Danish: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Danish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: 20 mg/0,5 ml Concentrate for solution for infusion
Danish: 20 mg/0,5 ml Koncentrat til infusionsvœske, opløsning
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Danish: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Danish: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Concentrate for solution for injection
Danish: Koncentrat til injektionsvœske til opløsning
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.
Danish: - Med hensyn til atomoxetin, som kun er indiceret til behandling af ADHD, konkluderede udvalget, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression har CHMP anbefalet, at markedsføringstilladelserne for lægemidlerne nævnt i bilag I opretholdes, for hvilke ændringerne af de relevante dele af produktresuméer og indlægssedler er gengivet i henholdsvis bilag III og IV.
English: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Danish: Storbritannien Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
English: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Danish: Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Danish: Organon , P.O.Box 20, NL - 5340 BH OSS
English: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Danish: Grœkenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Danish: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
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.
Danish: 2, navnlig hvad angår disses brug i den pædiatriske patientgruppe: fluoxetin, fluvoxamin, sertralin, paroxetin, citalopram, escitalopram, atomoxetin, duloxetin, venlafaxin, mianserin, milnacipran, reboxetin og mirtazapin.
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Danish: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
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
Danish: IV.I ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Danish: Danmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: Filchnerstr.
Danish: Tyskland Neosan Filchnerstr.
English: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Danish: Storbritannien 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
Danish: Storbritannien Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Fevarin Tabs 50 mg 50 mg
Danish: Fevarin Tabs 50 mg
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Danish: Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
English: PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Danish: Grœkenland PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
English: Oral Drops, solution Oral use
Danish: Orale dråber, opløsning Oral anvendelse
English: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Danish: Tyskland Lundbeck GmbH Postfach 900662
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Danish: Alfred Tiefenbacher (GmbH & Co.
English: Netherlands N.V. Organon t.a.v.
Danish: Organon t.a.v.
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Danish: Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Danish: Organon, Postbus 20, NL-5340 BH Oss
English: Synthon BV, Microweg 22, P.O.
Danish: Synthon BV, Microweg 22, P.O. Box 7071
English: Dispersable tablet
Danish: Dispergible tablet
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Danish: Tyskland F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
English: Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Danish: Storbritannien Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Danish: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Danish: D-53773 Hennef paroxetin-biomo 20mg 20 mg
English: Oral drops, solution
Danish: Orale dråber, opløsning
English: Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Danish: Danmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Danish: Tyskland ct-Arzneimittel GmbH Lengeder Str. 42a
English: Netherlands Centrafarm Services B.V. Postbus 289
Danish: Centrafarm Services B.V.
English: PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Danish: Grœkenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
Danish: Molièrelaan 225 1050 Brussel
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
Danish: Molièrelaan 225 1050 Brussel, Belgium
English: Pfizer Pharma GmbH Pfizerstr.
Danish: Tyskland Pfizer Pharma GmbH Pfizerstr.
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Danish: D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Danish: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: Fluoxemerck 20 mg 20 mg
Danish: Fluoxemerck 20 mg
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Danish: Storbritannien Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Danish: Danmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
English: Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Danish: Danmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Danish: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Danish: Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Danish: Storbritannien Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Danish: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Danish: KG Leipziger Str. 7-13
English: KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia
Danish: Slovenien KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, SI-8501
English: Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Danish: Danmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
English: Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Danish: Danmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
English: Denmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
Danish: Danmark Durascan Medical Products A/S, C. F. TietgensBoulevard 40, DK-5220
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
Danish: RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Danish: Danmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Danish: Demunterlaan 1 1090 BRUSSEL, Belgium
English: BOX 1161, 89143 BLAUBEUREN, Germany
Danish: Merckle GmbH, Ludwig-MerckleStrasse 3, P.O. BOX 1161, 89143 BLAUBEUREN, Germany
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Danish: Danmark 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
Danish: Danmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220
English: Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Danish: Sverige ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
English: Denmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
Danish: Danmark Durascan Medical Products A/S, C. F. Tietgen Boulevard 40, DK-5220
English: Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
Danish: Storbritannien Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
English: LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia
Danish: Slovenien LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia
English: Eli Lilly Holdings Limited, Kingsclere Road, Basinstoke, Hampshire RG21 6XA, Great Britain
Danish: Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 6XA, United Kingdom
English: Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Danish: Storbritannien Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
English: Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
Danish: Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
English: Oral solution
Danish: Prozit Oral Solution
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Danish: D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
English: Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
Danish: Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
English: Pharmaceutical form Route of administration
Danish: Lœgemiddelform Indgivelsesvej
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.
Danish: CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression.
English: Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Danish: Danmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
English: Dispersible tablets
Danish: Dispergible tablets
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Danish: Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
English: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Danish: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
English: Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Danish: Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
Danish: D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
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.
Danish: CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
English: VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: VENLAFAXIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen
English: H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Danish: Storbritannien H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
English: Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Danish: Danmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
English: Denmark N.V. Organon, P.O.
Danish: Danmark N.V.
English: Oral soulution
Danish: Oral vœske
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
Danish: D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
English: Netherlands I.C.C.
Danish: I.C.C.
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Danish: D-53773 Hennef fluoxetin-biomo 20mg Kapseln
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Danish: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Oropharyngeal use
Danish: Oral use
English: MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: MIRTAZAPIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsforings tilladelsen
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.
Danish: - CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
English: CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: CITALOPRAM indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indehaver af markedsføringstilladelsen
English: Lithuania Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
Danish: Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
English: MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Danish: MILNACIPRAN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union Medlems land Indeholder af markedsføringstilladelsen
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium
Danish: RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium
English: Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Danish: Danmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
English: Generics (UK) Ltd.
Danish: Niche Generics Ltd.
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Danish: D-53773 Hennef fluoxetin-biomo 20mg Tabletten