FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Slovenian: Luksemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Slovenian: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Slovenian: Nizozemska Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Concentrate for solution for injection
Slovenian: Koncentrat za pripravo raztopine za injiciranje
English: Fluvoxaminmaleat “Solvay” 50mgFilmtabletten
Slovenian: Fluvoxaminmaleat “Solvay” 50mg-Filmtabletten
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Slovenian: Če se pojavi ali poslabša katerikoli od zgoraj navedenih simptomov pri bolnikih, ki so mlajši od 18 let in jemljejo zdravilo [izmišljeno ime], morate obvestiti svojega zdravnika.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Slovenian: PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Slovenian: Velika Britanija Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Slovenian: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Slovenian: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Belgium BEXAL S.P.R.L.
Slovenian: BEXAL S.P.R.L.
English: Fluvoxaminmaleat “Solvay” 100mgFilmtabletten
Slovenian: Fluvoxaminmaleat “Solvay” 100mg-Filmtabletten
English: Whereas - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine;
Slovenian: Ker: - je Odbor upošteval posvetovalni postopek po členu 31 Direktive 2001/83/ES, kot je bila dopolnjena, za zdravila, ki vsebujejo atomoksetin, citalopram, escitalopram, fluoksetin, fluvoksamin, mianserin, milnacipran, mirtazapin, paroksetin, reboksetin, sertralin in venlafaksin;
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Slovenian: Nizozemska Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Slovenian: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
English: Remergil 15 mg/5ml Konzentrat
Slovenian: Remergil 15 mg/5ml Konzentrat 15 mg
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Slovenian: Nizozemska Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Seroxat 2mg/ml-orale Lösung
Slovenian: Seroxat 2mg/ml-orale Lösung 2mg/ml
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Slovenian: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Inpharmco-Mianserin30mg-Tabletten
Slovenian: Inpharmco-Mianserin-30mgTabletten
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Slovenian: Portugalska toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Slovenian: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Slovenian: Portugalska Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Slovenian: Nizozemska KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Slovenian: Madžarska Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
English: Fluoxetin Hexal 4mg/ml Loesung
Slovenian: Fluoxetin Hexal 4mg/ml Loesung 20 mg
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Slovenian: Nizozemska Alfred Tiefenbacher (GmbH & Co.
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Slovenian: Portugalska toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
English: Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Slovenian: Madžarska Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Slovenian: Nizozemska Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: The CHMP agreed that there was a potential signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs.
Slovenian: Odbor za zdravila za uporabo v humani medicini je soglašal, da pri otrocih in mladostnikih, ki so zdravljeni z zdravili SSRI in SNRI, obstaja potencialen signal povečanja samomorilnega vedenja, med drugim poskusov samomora in samomorilnih misli, in/ali povezanih vedenj, kot npr. samopoškodovanje, sovražnost in čustvena labilnost.
English: Prozac Durapac 90 mg Cápsulas Duras GastroResistentes
Slovenian: Prozac Durapac 90 mg Cápsulas Duras Gastro-Resistentes
English: Floccin 20mg/5mlLösung zum Einnehmen
Slovenian: Floccin 20mg/5ml-Lösung zum Einnehmen
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Slovenian: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Slovenian: Luksemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Fluxet 20 mg snap-tab 20 mg
Slovenian: Fluxet 20 mg snap-tab
English: Portal capsules 20 mg 20 mg
Slovenian: Portal capsules 20 mg
English: Fluoxetin „Lilly“ 20mglösliche Tabletten
Slovenian: Fluoxetin „Lilly“ 20mg-lösliche Tabletten
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Slovenian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Slovenian: Madžarska Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
English: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Slovenian: Portugalska Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
English: Desiflu voxamin 100 mg 100 mg
Slovenian: Desiflu voxamin 100 mg
English: Paroxetin “Salutas” 40mg-Filmtabletten
Slovenian: Paroxetin “Salutas” 40mgFilmtabletten
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Slovenian: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Slovenian: Portugalska Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
English: Tolvon, tablets 10 mg 10 mg
Slovenian: Tolvon, tablets 10 mg
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Slovenian: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Slovenian: 2696-901 Bobadela Portugal
English: Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Slovenian: Portugalska Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
English: Remeron 15 mg/ml, oral solution
Slovenian: Remeron 15 mg/ml, oral solution 15 mg/ml
English: - The Committee, in view of available data from clinical trials, concluded that there is a signal of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
Slovenian: - je Odbor za zdravila za uporabo v humani medicini na podlagi podatkov, dostopnih iz kliničnih preskušanj, zaključil, da pri otrocih in mladostnikih, ki so zdravljeni z zaviralci ponovnega prevzema, selektivnimi za serotonin, in zaviralci ponovnega prevzema serotonina in norepinefrina, kot npr. zgoraj omenjena zdravila, obstaja signal samomorilnega vedenja, med drugim poskusov samomora in samomorilnih misli, in/ali povezanih vedenj, kot npr. samopoškodovanje, sovražnost in čustvena labilnost;
English: Belgium A.H.P.
Slovenian: A.H.P.
English: Lithuania ICN Polfa Rzeszow, ul.
Slovenian: ICN Polfa Rzeszow, ul.
English: Inpharmco-Mianserin10mg-Tabletten
Slovenian: Inpharmco-Mianserin-10mgTabletten
English: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Slovenian: Portugalska Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Slovenian: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Belgium Laboratoires S.M.B.
Slovenian: Laboratoires S.M.B.
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)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO FLUOKSETIN, FLUVOKSAMIN, SERTRALIN, PAROKSETIN, CITALOPRAM, ESCITALOPRAM, ATOMOKSETIN, VENLAFAKSIN, MIANSERIN, MILNACIPRAN, REBOKSETIN IN MIRTAZAPIN (glejte Prilogo I)
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Slovenian: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Paroxetin “Sandoz” 20mg-Tabletten
Slovenian: Paroxetin “Sandoz” 20mgTabletten
English: Mutan 20mgFilmtabletten
Slovenian: Mutan 20mg-Filmtabletten
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Slovenian: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Desiflu voxamin 50 mg 50 mg
Slovenian: Desiflu voxamin 50 mg
English: ZOLOFT OC 20mg/ml 20mg/ml
Slovenian: ZOLOFT OC 20mg/ml
English: Paroxetin “Merckle” 20mg-Filmtabletten
Slovenian: Paroxetin “Merckle” 20mgFilmtabletten
English: Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Slovenian: Portugalska Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
English: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Slovenian: Madžarska Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
English: Mianserin 30mg Holsten 30 mg
Slovenian: Mianserin 30mg Holsten
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Slovenian: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Slovenian: Portugalska Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
English: Mianserin Organon 10mg 10 mg
Slovenian: Mianserin Organon 10mg
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Slovenian: III.2 DOPOLNILA, KI SE VKLJUČIJO V ZADEVNO POGLAVJE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA ATOMOKSETIN
English: Oropharyngeal use
Slovenian: Orofaringealna uporaba
English: SEROXAT 30 MG 30 mg
Slovenian: SEROXAT 30 MG
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Slovenian: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Slovenian: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Tolvon, tablets 3 mg 30 mg
Slovenian: Tolvon, tablets 3 mg
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Slovenian: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Mianserin Organon 60mg 60 mg
Slovenian: Mianserin Organon 60mg
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Slovenian: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovenian: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Slovenian: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Mianserin „Arcana“ 30mg-Filmtabletten
Slovenian: Mianserin „Arcana“ 30mgFilmtabletten
English: Box 20, Oss, Netherland
Slovenian: Organon, P.O. Box 20, Oss, Netherland
English: PAROXETINA HEXAL 40 mg
Slovenian: PAROXETINA HEXAL 40 mg 40 mg
English: Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Slovenian: Madžarska Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Slovenian: Nizozemska Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovenian: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Slovenian: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
English: Fluoxetin HEXAL 10mg Tabs
Slovenian: Fluoxetin HEXAL 10mg Tabs 10 mg
English: Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Slovenian: Madžarska Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
English: Paroxetin “Arcana” 20mg-Filmtabletten
Slovenian: Paroxetin “Arcana” 20mgFilmtabletten
English: Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Slovenian: Portugalska Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
English: Fluoxetin „Lannacher“ 20mg-Kapseln
Slovenian: Fluoxetin „Lannacher“ 20mgKapseln
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Slovenian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Slovenian: KG Elisabeth-Selbert-Str. 1
English: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Slovenian: Portugalska Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Slovenian: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Paroxetin “Interpharm” 20mg-Filmtabletten
Slovenian: Paroxetin “Interpharm” 20mgFilmtabletten
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Slovenian: Organon , P.O.Box 20, NL - 5340 BH OSS
English: EDRONAX 4 MG N
Slovenian: EDRONAX 4 MG
English: Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Slovenian: Portugalska Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Slovenian: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Mirtatsapiini APS Limited 15 mg
Slovenian: Mirtatsapiini APS Limited
English: PAROXETINA APOTEX-FARMA
Slovenian: PAROXETINA APOTEXFARMA
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Slovenian: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Fevarin Tabs 100 mg 100 mg
Slovenian: Fevarin Tabs 100 mg
English: Trevilor retard 75 mg 75 mg
Slovenian: Trevilor retard 75 mg
English: Tolvon 60mgFilmtabletten
Slovenian: Tolvon 60mg-Filmtabletten
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Slovenian: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Netherlands Centrafarm Services B.V. Postbus 289
Slovenian: Nizozemska Centrafarm Services B.V.
English: Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131 Algés Portugal
Slovenian: Portugalska Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
English: Mianserin 10mg Holsten 10 mg
Slovenian: Mianserin 10mg Holsten
English: Mirtazapin “Alternova” 45mg-Filmtabletten
Slovenian: Mirtazapin “Alternova” 45mgFilmtabletten
English: Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
Slovenian: Madžarska Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
English: Fevarin Tabs 50 mg 50 mg
Slovenian: Fevarin Tabs 50 mg
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Slovenian: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
English: Mianserin „Arcana“ 10mg-Filmtabletten
Slovenian: Mianserin „Arcana“ 10mgFilmtabletten
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.
Slovenian: - je Odbor v zvezi z atomoksetinom, ki je indiciran le za zdravljenje ADHD, zaključil, da je treba v Povzetke glavnih značilnosti zdravila in zadevno poglavje Navodil za uporabo zdravil, ki vsebujejo atomoksetin, vključiti opozorilo, ki bo odražalo pogostejše opažanje sovražnosti (večinoma nasilnega vedenja, nasprotovalnega vedenja in jeze) in čustvene labilnosti v kliničnih preskušanjih pri otrocih in mladostnikih, ki so bili zdravljeni z atomoksetinom, v primerjavi s tistimi, ki so prejemali placebo, ter opozorilo, ki nakazuje neučinkovitost pri zdravljenju depresije.
English: Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal
Slovenian: Portugalska Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
English: SERTRALIN IREX 50 MG
Slovenian: SERTRALIN IREX 50 MG 50 mg
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.
Slovenian: , zlasti glede njihove uporabe pri otrocih: fluoksetin, fluvoksamin, sertralin, paroksetin, citalopram, escitalopram, atomoksetin, duloksetin, venlafaksin, mianserin, milnacipran, reboksetin in mirtazapin.
English: LERIVON 30MG 30 mg
Slovenian: LERIVON 30MG
English: Tolvon 60 mg, tablets 60 mg
Slovenian: Tolvon 60 mg, tablets
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Slovenian: Zoloft 25 mg + 50 mg 25 mg + 50 mg
English: Mianserin-TEVA 30 mg 30 mg
Slovenian: Mianserin-TEVA 30 mg
English: Fluoxenorm “Genericon” 40mg-Kapseln
Slovenian: Fluoxenorm “Genericon” 40mgKapseln
English: Fluoxenorm “Genericon” 20mg-Filmtabletten
Slovenian: Fluoxenorm “Genericon” 20mgFilmtabletten
English: Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Slovenian: Madžarska Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
English: Fluoxetine „Stada“ 20mg-Kapseln
Slovenian: Fluoxetine „Stada“ 20mgKapseln
English: Milnacipran Pierre Fabre 25 mg
Slovenian: Milnacipran Pierre Fabre
English: ADOFEN 20 mg oral solution
Slovenian: ADOFEN 20 mg oral solution 20 mg
English: Paroxetin “1A Pharma” 40mg-Filmtabletten
Slovenian: Paroxetin “1A Pharma” 40mgFilmtabletten
English: Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131 Algés Portugal
Slovenian: Portugalska Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
English: RENEURON 20 mg oral solution
Slovenian: RENEURON 20 mg oral solution 20 mg
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Slovenian: Luksemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Mirtabene „ratiopharm“ 45mg-Filmtabletten
Slovenian: Mirtabene „ratiopharm“ 45mgFilmtabletten
English: Mirtazapin “Alternova” 30mg-Filmtabletten
Slovenian: Mirtazapin “Alternova” 30mgFilmtabletten
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovenian: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: PROZAC 20 mg kapszula 20 mg
Slovenian: PROZAC 20 mg kapszula
English: Dispersable tablet
Slovenian: Peroralna disperzibilna tableta
English: Tolvon 30mgFilmtabletten
Slovenian: Tolvon 30mg-Filmtabletten
English: Fluoxetin “Genericon” 20mg-Filmtabletten
Slovenian: Fluoxetin “Genericon” 20mgFilmtabletten
English: QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed 20 mg
Slovenian: QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Slovenian: Organon, Postbus 20, NL-5340 BH Oss
English: Euro-Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
Slovenian: Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
English: DALCIPRAN 25MG 25 mg
Slovenian: DALCIPRAN 25MG
English: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Slovenian: Luksemburg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
English: Paroxetin beta 20mg 20 mg
Slovenian: Paroxetin beta 20mg
English: Mirtazapine Sandoz 15 mg
Slovenian: MIRTAZAPINA SANDOZ 15 mg
English: Mirtazapin “Alternova” 15mg-Filmtabletten
Slovenian: Mirtazapin “Alternova” 15mgFilmtabletten
English: Fluoxetin-TEVA 10 mg Tabletten
Slovenian: Fluoxetin-TEVA 10 mg Tabletten 10 mg
English: Felicium 20mg-Kapseln 20mg
Slovenian: Felicium 20mg-Kapseln
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovenian: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Netherlands Katwijk Farma B.V. Postbus 408
Slovenian: Nizozemska Katwijk Farma B.V.
English: MIABENE 10 MG 10 mg
Slovenian: MIABENE 10 MG
English: MIABENE 30 MG 30 mg
Slovenian: MIABENE 30 MG
English: Synthon BV, Microweg 22, P.O.
Slovenian: Synthon BV, Microweg 22, P.O. Box 7071
English: Mianserin-TEVA 10 mg 10 mg
Slovenian: Mianserin-TEVA 10 mg
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Slovenian: Nizozemska Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Slovenian: Madžarska Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
English: Fluvoxamin “1A Pharma” 50mg-Filmtabletten
Slovenian: Fluvoxamin “1A Pharma” 50mgFilmtabletten
English: LERIVON 60MG 60 mg
Slovenian: LERIVON 60MG
English: Fluoxemerck 20 mg 20 mg
Slovenian: Fluoxemerck 20 mg
English: Remeron 15 mg, tablets 15 mg
Slovenian: Remeron 15 mg, tablets
English: Mianserin-neuraxpharm 60mg
Slovenian: Mianserin-neuraxpharm 60mg 60 mg
English: Paroxetina Apotex Europe 20 mg
Slovenian: Paroxetina Apotex Europe
English: PORTAL 20 mg kapszula 20 mg
Slovenian: PORTAL 20 mg kapszula