FrancophonIA/ELRC3.0 huggingface dataset:
English: [Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Slovenian: Zdravila [izmišljeno ime] ne smete uporabiti za zdravljenje otrok in mladostnikov, mlajših od 18 let <razen pri bolnikih z [odobreno indikacijo]>.
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Slovenian: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Slovenian: Madžarska Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
English: The CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out respectively in Annexes III and IV.
Slovenian: je Odbor za zdravila za uporabo v humani medicini priporočil vzdrževanje dovoljenj za promet za zdravila iz Priloge I, za katera so v Prilogi III določena dopolnila zadevnih poglavij Povzetkov glavnih značilnosti zdravila in v Prilogi IV določena dopolnila zadevnih poglavij Navodil za uporabo.
English: Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
Slovenian: Madžarska Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
English: Suspension
Slovenian: Suspenzija
English: The EC requested the CHMP to give its opinion on whether the marketing authorisation for medicinal products containing the above mentioned active substances should be maintained, varied, suspended or withdrawn.
Slovenian: Evropska komisija je zaprosila Odbor za zdravila za uporabo v humani medicini, da poda mnenje o vzdrževanju, spremembi, začasnem preklicu ali umiku dovoljenja za promet z zdravili, ki vsebujejo zgoraj omenjene zdravilne učinkovine.
English: Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary
Slovenian: Madžarska Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary
English: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Slovenian: Portugalska Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
English: Luxembourg S.M.B.
Slovenian: Luksemburg S.M.B.
English: Box 7071
Slovenian: Postbus 7071
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Slovenian: Opomba: Ta razdelek Navodil za uporabo je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
English: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Slovenian: Luksemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Slovenian: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Slovenian: Nizozemska Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary
Slovenian: Madžarska Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary
English: Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Slovenian: Portugalska Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Slovenian: Nizozemska Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Slovenian: Nizozemska Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Slovenian: Madžarska Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100
English: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Slovenian: Velika Britanija Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Slovenian: Nizozemska Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Slovenian: Portugalska Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Slovenian: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Slovenian: Portugalska Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Slovenian: Odbor za zdravila za uporabo v humani medicini je pregledal podatke, ki so jih v zvezi s signalom samomorilnega vedenja pri otrocih in mladostnikih predložili imetniki dovoljenj za promet z zdravili.
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Slovenian: Nizozemska Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Slovenian: Portugalska Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Slovenian: Portugalska Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
English: Lange Munteplein 7b 4, 8500
Slovenian: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Slovenian: Portugalska Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
English: Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Slovenian: Portugalska Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
English: Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary
Slovenian: Madžarska Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary
English: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Slovenian: Luksemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
English: Remeron 3mg/mlKonzentrat zur Herstellung einer Infusionslösung
Slovenian: Remeron 3mg/ml-Konzentrat zur Herstellung einer Infusionslösung
English: Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Slovenian: Portugalska Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Slovenian: Nizozemska AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Slovenian: Portugalska Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
English: Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Slovenian: Madžarska Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Slovenian: Nizozemska Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
Slovenian: Portugalska Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Slovenian: Portugalska Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
English: Belgium OLYMPO PHARMA B.V.B.A.
Slovenian: OLYMPO PHARMA B.V.B.A.
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Slovenian: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Slovenian: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Slovenian: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Slovenian: Nizozemska Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
English: Eli Lilly Nederland BV Postbus 379
Slovenian: Nizozemska Eli Lilly Nederland BV Postbus 379
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Slovenian: Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Slovenian: Zdravila SNRI učinkujejo na živčna prenašalca norepinefrin in serotonin.
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Slovenian: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Slovenian: Nizozemska ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Slovenian: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209 Carnaxide Portugal
Slovenian: Portugalska Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209
English: Capsule, soft
Slovenian: Kapsula, mehka
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Slovenian: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: MOM Park Gesztenyés torony, 1124 Budapest, Hungary
Slovenian: MOM Park Gesztenyés torony, 1124
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Slovenian: via Nocera Umbra 75 00100 Roma Italy
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Slovenian: Nizozemska GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal
Slovenian: Portugalska Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Slovenian: IV.2 DOPOLNILA, KI SE VKLJUČIJO V ZADEVNO POGLAVJE NAVODILA ZA UPORABO ZA ATOMOKSETIN
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Slovenian: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Slovenian: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Slovenian: Portugalska Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S.
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Slovenian: 2 SNRI pomeni „Serotonin-Norepinephrine Reuptake Inhibitor“ [zaviralec ponovnega prevzema serotonina in norepinefrina].
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Slovenian: Luksemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Slovenian: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Slovenian: Nizozemska Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Slovenian: Portugalska Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Slovenian: Luksemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Slovenian: Nizozemska Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Slovenian: Portugalska Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
English: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Slovenian: Portugalska Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Slovenian: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Slovenian: Nizozemska Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Slovenian: Nizozemska Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Slovenian: Portugalska Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Slovenian: Madžarska Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Slovenian: Portugalska Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Slovenian: Nizozemska Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Slovenian: Nizozemska Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Slovenian: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: B.V. Postbus 75
Slovenian: Postbus 75
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Slovenian: Nizozemska Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Slovenian: Luksemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Slovenian: Nizozemska Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Slovenian: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
Slovenian: Pharmaceutical Works Polpharma S.A., ul.
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Slovenian: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Slovenian: Nizozemska Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Slovenian: Portugalska Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
English: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Slovenian: Portugalska Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
English: Desifluvox amin 25 mg 25 mg
Slovenian: Desifluvox amin 25 mg
English: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Slovenian: Madžarska Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Slovenian: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Slovenian: Viale Amelia, 70 00181 Roma Italy
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Slovenian: Nizozemska Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Slovenian: Madžarska Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Slovenian: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Slovenian: Portugalska Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
English: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Slovenian: Portugalska Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Slovenian: Nizozemska Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Slovenian: Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Slovenian: Rijksweg 12 2870 Puurs, Belgium
English: D-64206 Darmstadt paroxedura 30 mg Filmtabletten
Slovenian: D-64206 Darmstadt paroxedura 30 mg Filmtabletten 30 mg
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Slovenian: Nizozemska Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Remeron 15mg/mlLösung zum Einnehmen
Slovenian: Remeron 15mg/ml-Lösung zum Einnehmen
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Slovenian: Poleg tega je bil pri skoraj vseh zdravilih in indikacijah ugotovljen signal v zvezi s povezanimi neželenimi pojavi, kot npr. sovražnost, samopoškodovanje in čustvena labilnost.
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Slovenian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Slovenian: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Slovenian: Portugalska Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Slovenian: Nizozemska Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Slovenian: Nizozemska Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Slovenian: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Slovenian: Velika Britanija Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Slovenian: Nizozemska Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Slovenian: Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Slovenian: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Slovenian: Luksemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Slovenian: Portugalska Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Slovenian: Portugalska ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
English: Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Slovenian: Portugalska Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Slovenian: Nizozemska Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: 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.
Slovenian: S samomorom povezana vedenja (poskus samomora in samomorilne misli) ter sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jeza) so bila v kliničnih preskušanjih pogosteje opažena pri otrocih in mladostnikih, ki so bili zdravljeni z antidepresivnimi zdravili, v primerjavi s tistimi, ki so prejemali placebo.
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Slovenian: Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Slovenian: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Slovenian: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Slovenian: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Slovenian: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with placebo.
Slovenian: Sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jeza) ter čustvena labilnost so bila v kliničnih preskušanjih pogosteje opažena pri otrocih in mladostnikih, ki so bili zdravljeni z zdravilom [izmišljeno ime], v primerjavi s tistimi, ki so prejemali placebo.
English: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Slovenian: Portugalska Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Slovenian: Če se po uvedbi zdravljenja pojavi ali poslabša katerikoli od zgoraj navedenih simptomov, morate obvestiti svojega zdravnika.
English: ORAL SOLUTION
Slovenian: Prozit Oral Solution
English: D-64206 Darmstadt paroxedura 20 mg Filmtabletten
Slovenian: D-64206 Darmstadt paroxedura 20 mg Filmtabletten 20 mg
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Slovenian: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland