FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Dutch: Denemarken Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Dutch: Rue-de-la-Pastorale 26-28
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)
Dutch: ALGEHELE SAMENVATTING VAN DE WETENSCHAPPELIJKE BEOORDELING VAN GENEESMIDDELEN DIE FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, ATOMOXETINE, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE BEVATTEN (zie bijlage I)
English: Fevarin tablets
Dutch: Fevarin tabeltten
English: Belgium A.H.P.
Dutch: A.H.P.
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.
Dutch: Het CHMP kwam derhalve tot de conclusie dat gewaarschuwd moest worden tegen het feit dat vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woedeuitbarstingen) en emotionele labiliteit vaker voorkwamen in klinische onderzoeken onder kinderen en adolescenten die behandeld werden met atomoxetine dan bij degenen die met placebo behandeld werden en dat een waarschuwing moest worden opgenomen in de samenvattingen van de productkenmerken en de relevante rubriek van de bijsluiter van geneesmiddelen die atomoxetine bevatten.
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Dutch: Litouwen Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Dutch: Litouwen Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Dutch: Denemarken Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Dutch: Hongarije Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
English: SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Dutch: Denemarken Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Dutch: Nederland Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Dutch: SpanjeSpanje TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
English: Ratiopharm Arzneimittel Vertriebs Ges.m.b.H., Albert Schweitzer-Gasse 3, 1140 Wien, Austria
Dutch: Oostenrijk Ratiopharm Arzneimittel Vertriebs Ges.m.b.H., Albert Schweitzer-Gasse 3, 1140 Wien, Austria
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Dutch: Denemarken Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: Oostenrijk F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
English: UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Dutch: Griekenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Dutch: Denemarken Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Dutch: Slowakije Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
English: Temmler Pharma GmbH & Co.KG Postfach 2269
Dutch: Duitsland Temmler Pharma GmbH & Co.KG Postfach 2269
English: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Dutch: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
English: Interpharm ProduktionsgmbH., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: Oostenrijk Interpharm ProduktionsgmbH., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
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.
Dutch: 2-middelen, met name wat betreft het gebruik ervan in de pediatrische populatie: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine en mirtazapine.
English: Gerot Pharmazeutika Ges.m.b.H., Arnethgasse 3, 1160 Wien, Austria
Dutch: Oostenrijk Gerot Pharmazeutika Ges.m.b.H., Arnethgasse 3, 1160 Wien, Austria
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Dutch: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Dutch: Denemarken Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Denmark Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
Dutch: Denemarken Generics (UK) Ltd., Station Close, Potters Bar, UK-EN61TL
English: Torrex Pharma Ges.m.b.H., Lange Gasse 76/17, 1080 Wien, Austria
Dutch: Oostenrijk Torrex Pharma Ges.m.b.H., Lange Gasse 76/17, 1080 Wien, Austria
English: FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Dutch: Griekenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
English: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Dutch: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slowakije
English: Synthon B.V.
Dutch: B.V.
English: Hexal Pharma GmbH, Wilhelminenstr.
Dutch: Oostenrijk Hexal Pharma GmbH, Wilhelminenstr.
English: Filchnerstr.
Dutch: Duitsland Neosan Filchnerstr.
English: Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Dutch: Hongarije Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Dutch: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Dutch: Denemarken Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
Dutch: Noorwegen Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Dutch: Denemarken Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Netherlands Centrafarm Services B.V. Postbus 289
Dutch: Nederland Centrafarm Services B.V.
English: Allen Pharmazeutika Ges.m.b.H., Albert Schweitzer Gasse 6, 1140 Wien, Austria
Dutch: Oostenrijk Allen Pharmazeutika Ges.m.b.H., Albert Schweitzer Gasse 6, 1140 Wien, Austria
English: Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Dutch: Hongarije Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Dutch: Organon , P.O.Box 20, NL - 5340 BH OSS
English: Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
Dutch: Hongarije Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Dutch: Duitsland F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
English: PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Dutch: Griekenland PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
English: 15 Rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
Dutch: Frankrijk IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
English: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
Dutch: Frankrijk IVAX 15 Rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
English: Interpharm Produktions Ges.m.b.H., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: Oostenrijk Interpharm Produktions Ges.m.b.H., Dr. Karl Lueger Ring 6, 1010 Wien, Austria
English: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Dutch: Duitsland Lundbeck GmbH Postfach 900662
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Dutch: Denemarken Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Dutch: Hongarije Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
English: Netherlands GenRx B.V. Postbus 75
Dutch: Nederland GenRx B.V.
English: Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
Dutch: Noorwegen Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Dutch: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Dutch: Luxemburg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Dutch: Luxemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Dutch: Slowakije Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
English: Pfizer Pharma GmbH Pfizerstr.
Dutch: Duitsland Pfizer Pharma GmbH Pfizerstr.
English: Christensens Vej 1 DK-3000
Dutch: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000
English: PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Dutch: Griekenland CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Dutch: Organon, Postbus 20, NL-5340 BH Oss
English: Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
Dutch: Litouwen Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Dutch: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: 37 avenue Pierre Premier de Serbie 75008 Paris, France
Dutch: Frankrijk Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris, France
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Dutch: Denemarken Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
English: Netherlands N.V. Organon t.a.v.
Dutch: Organon t.a.v.
English: Film-coated tablets
Dutch: Filmomhulde tablets
English: Netherlands Katwijk Farma B.V. Postbus 408
Dutch: Nederland Katwijk Farma B.V.
English: Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
Dutch: Litouwen Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
English: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Dutch: Hongarije Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
English: Member State Marketing Authorisation Holder Invented Name
Dutch: Houder van de vergunning voor het in handel brengen
English: Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Dutch: Nederland Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
English: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Dutch: Hongarije Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Dutch: D-53773 Hennef paroxetin-biomo 20mg 20 mg
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Dutch: Duitsland ct-Arzneimittel GmbH Lengeder Str. 42a
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
Dutch: Molièrelaan 225 1050 Brussel
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Dutch: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000 Fraderiksberg
Dutch: Slowakije A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000
English: Genericon Pharma Ges.m.b.H., Schloßplatz 1, 8502 Lannach, Austria
Dutch: Oostenrijk Genericon Pharma Ges.m.b.H., Schloßplatz 1, 8502 Lannach, Austria
English: 37 avenue Pierre Premier de Serbie 75008 Paris- France
Dutch: Frankrijk Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris- France
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
Dutch: Molièrelaan 225 1050 Brussel, Belgium
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Dutch: Nederland Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Dispersable tablet
Dutch: Dispergeerbare tablet
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Dutch: D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
English: 49 Avenue Georges Pompidou 92300 Levallois Perret - France
Dutch: Frankrijk SANDOZ 49 Avenue Georges Pompidou 92300 Levallois Perret - France
English: Luxembourg ORGANON EUROPE B.V. Kloosterstraat 6 5349 AB OSS The Netherlands
Dutch: Luxemburg ORGANON EUROPE B.V. Kloosterstraat 6 5349 AB OSS The Netherlands
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Dutch: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Dutch: Frankrijk Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
Dutch: Hongarije Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
English: Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Dutch: Denemarken Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
Dutch: Slowakije EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU- 1160 Budapest
English: Netherlands GlaxoSmithKline B.V. Postbus 780
Dutch: Nederland GlaxoSmithKline B.V.
English: 49 avenue Georges Pompidou 92300 Levallois-Perret France
Dutch: Frankrijk SANDOZ 49 avenue Georges Pompidou 92300 Levallois-Perret France
English: Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Dutch: Denemarken Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
English: Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Dutch: Denemarken Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
English: Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Dutch: Nederland H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
English: Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Dutch: Luxemburg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Dutch: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
Dutch: Slowakije EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
Dutch: Langetermijn veiligheids door patiënten jonger dan 18 jaar.gegevens van [Fantasienaam] over groei, ontwikkeling en cognitieve en gedragsontwikkeling ontbreken in deze leeftijdsgroep.
English: ICN Polfa Rzesów S.A., ul.
Dutch: Slowakije ICN Polfa Rzesów S.A., ul.
English: Wyeth-Lederle Pharma Ges.m.b.H., Storchengasse 1, 1150 Wien, Austria
Dutch: Oostenrijk Wyeth-Lederle Pharma Ges.m.b.H., Storchengasse 1, 1150 Wien, Austria
English: 37 avenue Pierre Premier de Serbie 75008 Paris -france
Dutch: Frankrijk Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris -france
English: Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Dutch: Denemarken Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Dutch: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Pierre Fabre Medicament, 45, Place Abel Gance, 92100 Boulogne, France
Dutch: Oostenrijk Pierre Fabre Medicament, 45, Place Abel Gance, 92100 Boulogne, France
English: Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Dutch: Luxemburg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Dutch: Denemarken Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
English: Wyeth Lederle Pharma GmbH, Storchengasse 1, A- 1150 Wien
Dutch: Slowakije Wyeth Lederle Pharma GmbH, Storchengasse 1, A- 1150 Wien
English: Solvay Pharmaceuticals B.V., C. J. van Houtenlaan 36, Weesp, The Netherlands
Dutch: Noorwegen Solvay Pharmaceuticals B.V., C. J. van Houtenlaan 36, Weesp, The
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG), Van-der-Smissen-Strasse 1, D22767 Hamburg
Dutch: Nederland Alfred Tiefenbacher (GmbH & Co. KG), Van-der-Smissen-Strasse 1, D22767 Hamburg
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Dutch: Demunterlaan 1 1090 BRUSSEL, Belgium
English: Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
Dutch: Slowakije Ratiopharm GmbH , Gras-Orco-Strasse 3, D - 890 79 Ulm
English: MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Dutch: MIRTAZAPINE-bevattende geneesmiddelen met een vergunning voor het in de handel brengen in de Europese Unie
English: Apotex Europe Ltd., Rowan House, 41 London Street, Reading Berkshire UKRG14PS
Dutch: Hongarije Apotex Europe Ltd., Rowan House, 41 London Street, Reading Berkshire UKRG14PS
English: Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Dutch: Zweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Dutch: Denemarken Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
English: Solvay Pharmaceuticals B.V., CJ van Houtenlaan 36, NL - 1381 CP Weep
Dutch: Slowakije Solvay Pharmaceuticals B.V., CJ van Houtenlaan 36, NL - 1381 CP Weep
English: Lithuania Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
Dutch: Litouwen Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
English: Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK
Dutch: Hongarije Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK
English: Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG, UK
Dutch: Hongarije Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG, UK
English: Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Dutch: Denemarken Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
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
Dutch: IV.I IN DE DESBETREFFENDE PARAGRAAF VAN DE BIJSLUITER VOOR FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE EN MIRTAZAPINE OP TE NEMEN WIJZIGINGEN
English: Luxembourg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
Dutch: Luxemburg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
Dutch: Litouwen KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
English: Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
Dutch: Slowakije Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
Dutch: RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
English: Combino Pharm, S.L., Fructuós Gelabert, 6-8, 08970 SANT JOAN DESPÍ Barcelona, Spain
Dutch: Combino Pharm, S.L., Fructuós Gelabert, 6-8, 08970 SANT JOAN DESPÍ Barcelona, Spanje
English: Luxembourg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
Dutch: Luxemburg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
English: Luxembourg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium
Dutch: Luxemburg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Dutch: D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
English: Belgium ORGANON EUROPE B.V. Kloosterstraat 6 5349 AB OSS The Netherlands
Dutch: ORGANON EUROPE B.V. Kloosterstraat 6 5349 AB OSS The Netherlands
English: Netherlands Sandoz B.V. Postbus 216
Dutch: Nederland Sandoz B.V.
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
Dutch: Luxemburg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
English: REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Dutch: REBOXETINE-bevattende geneesmiddelen met een vergunning voor het in de handel brengen in de Europese Unie
English: Lek Pharmaceuticals d.d., Verevskova 57, Ljubljana, 1526, Slovenia
Dutch: Hongarije Lek Pharmaceuticals d.d., Verevskova 57, Ljubljana, 1526, Slovenia
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
Dutch: Litouwen KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
English: Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Dutch: Denemarken Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
Dutch: Luxemburg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
English: Lithuania Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1, A-8502 Lannach, Austria
Dutch: Litouwen Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1, A-8502 Lannach, Austria
English: Netherlands Apothecon B.V. Postbus 324
Dutch: Nederland Apothecon B.V.
English: Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
Dutch: Slowakije Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
English: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Dutch: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
Dutch: D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Dutch: Denemarken HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
English: Netherlands Alpharma B.V. Postbus 313
Dutch: Nederland Alpharma B.V.
English: Oral solution, single dose Oral use
Dutch: Drank, single dose
English: EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary.
Dutch: Hongarije EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary.
English: Dispersible tablets
Dutch: Dispergeerbare tablets
English: VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Dutch: VENLAFAXINE-bevattende geneesmiddelen met een vergunning voor het in de handel brengen in de Europese Unie