FrancophonIA/ELRC3.0 huggingface dataset:
Greek: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL;
Polish: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Greek: Πορτογαλία ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Polish: Portugalia ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Greek: Πορτογαλία Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Polish: Portugalia Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Greek: Πορτογαλία Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Polish: Portugalia Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Greek: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE;
Polish: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Greek: 08025 Barcelona Espanha
Polish: 08013 Barcelona, Spain
Greek: Νορβηγία Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Polish: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Greek: 43. MOM Park Gesztenyés torony, 1124
Polish: MOM Park Gesztenyés torony, 1124 Budapest, Hungary
Greek: Σουηδία A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK)
Polish: A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK)
Greek: Γερµανία Heumann Pharma GmbH & Co. Generica KG
Polish: Heumann Pharma GmbH & Co. Generica KG
Greek: Ιρλανδία Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0FL, UK
Polish: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0FL, UK
Greek: Σλοβενία Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
Polish: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Greek: Ολλανδία Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Polish: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Greek: Λουξεµβούργο Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Polish: Luksemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Greek: Πορτογαλία Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
Polish: Portugalia Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
Greek: Σλοβακία Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Polish: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Greek: Granatieri 50018 Scandicci - Firenze Italy
Polish: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Greek: LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
Polish: Hiszpania LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
Greek: Νορβηγία IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Polish: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Greek: Γερµανία Rodleben Pharma GmbH Postfach 205
Polish: Rodleben Pharma GmbH Postfach 205
Greek: Ολλανδία Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Polish: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Greek: Πολωνία Pharmacia & Upjohn S.p.A., via Robert Koch 1.2, 20 152 Milano, IT
Polish: Pharmacia & Upjohn S.p.A., via Robert Koch 1.2, 20 152 Milano, IT
Greek: Ολλανδία Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Polish: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Greek: Πορτογαλία Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Polish: Portugalia Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Greek: Λουξεµβούργο WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Polish: Luksemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Greek: Πορτογαλία Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
Polish: Portugalia Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
Greek: NL - 1380 DA Weesp] C.J.
Polish: NL - 1380 DA Weesp] C.J. van Houtenlaan 36
Greek: Ολλανδία Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Polish: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Greek: Zoloft 25 mg + 50 mg 25 mg + 50 mg Επικαλυµµένο µε λεπτό υµένιο δισκίο
Polish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Tabletka powlekana
Greek: Ολλανδία Hexal AG, Postfach 1263, D-83602 Holzkirchen
Polish: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Greek: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Polish: Hiszpania MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Greek: Ουγγαρία Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Polish: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Greek: Επιπλέον, υπήρξε προειδοποιητικό σήµα εκδήλωσης παρεµφερών ανεπιθύµητων ενεργειών όπως εχθρική συµπεριφορά, αυτοτραυµατισµός και συναισθηµατική αστάθεια για όλα σχεδόν τα προϊόντα και τις ενδείξεις τους.
Polish: Ponadto przy prawie wszystkich produktach i wskazaniach do stosowania wystąpiły oznaki powiązanych działań niepożądanych, takich jak wrogość, autoagresja oraz labilność emocjonalna.
Greek: Πορτογαλία Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Polish: Portugalia Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Greek: LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Polish: Hiszpania LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Greek: Πορτογαλία Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Polish: Portugalia Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Greek: Πορτογαλία Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Polish: Portugalia Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Greek: JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Polish: Hiszpania JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Greek: Πορτογαλία Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Polish: Portugalia Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Greek: Πορτογαλία Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Polish: Portugalia Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Greek: Pelplińska 19, 83-200 Starogard Gdański, Poland
Polish: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
Greek: INVICTA FARMA, S.A., Avda.
Polish: Hiszpania INVICTA FARMA, S.A., Avda.
Greek: Ολλανδία Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Polish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Greek: Ισλανδία Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Polish: Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Greek: 53., MOM Park F épület, 1123 Budapest, Hungary
Polish: Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Greek: JUSTE, S.A.Q.F., Juan Ign 28027acio Luca de Tena, 8, Madrid, Spain
Polish: Hiszpania JUSTE, S.A.Q.F., Juan Ign 28027acio Luca de Tena, 8, Madrid, Spain
Greek: Fabrik , Holger Danskaes Vej 89, DK - 2000
Polish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Greek: Ολλανδία GlaxoSmithKline B.V.
Polish: GlaxoSmithKline B.V.
Greek: Ολλανδία Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Polish: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Greek: Γερµανία TAD Pharma GmbH Postfach 720
Polish: TAD Pharma GmbH Postfach 720
Greek: Ολλανδία Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Polish: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Greek: GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
Polish: Hiszpania GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
Greek: Φινλανδία Teva Pharma B.V.
Polish: Teva Pharma B.V.
Greek: Λιθουανία Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Polish: Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Greek: CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Polish: Hiszpania CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Greek: ΒΕΝΛΑΦΑΞΙΝΗ, ΜΙΑΝΣΕΡΙΝΗ, ΜΙΛΝΑΣΙΠΡΑΝΗ, ΡΕΜΠΟΞΕΤΙΝΗ ΚΑΙ ΜΙΡΤΑΖΑΠΙΝΗ
Polish: WENLAFAKSYNY, MIANSERYNY, MILNACIPRANU, REBOKSETYNY I MIRTAZAPINY
Greek: Ουγγαρία Pfizer Kft.1123 Bp, Alkotás u.
Polish: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Greek: Πορτογαλία toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Polish: Portugalia toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Greek: Γερµανία Aliud Pharma GmbH & Co.KG Postfach 1380
Polish: Aliud Pharma GmbH & Co.KG Postfach 1380
Greek: FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
Polish: Hiszpania FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
Greek: Γερµανία S.A. Laboratoires S.M.B.
Polish: S.A. Laboratoires S.M.B.
Greek: Γερµανία H.Lundbeck A/S Ottiliavej 7-9
Polish: H.Lundbeck A/S Ottiliavej 7-9
Greek: DEXTER FARMACEUTICA, S.A., Avda.
Polish: Hiszpania DEXTER FARMACEUTICA, S.A., Avda.
Greek: Γερµανία Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Polish: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Greek: Ουγγαρία Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Polish: Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Greek: 1 SSRI σηµαίνει «εκλεκτικός αναστολέας της επαναπρόσληψης σεροτονίνης (ΕΑΕΣ)».
Polish: 1 Skrót SSRI oznacza „Selektywny inhibitor wychwytu zwrotnego serotoniny".
Greek: Η CHMP έκρινε ότι στις µελέτες της ατοµοξετίνης δεν υπήρξε προειδοποιητικό σήµα αυξηµένου κινδύνου αυτοκτονικής συµπεριφοράς, υφίσταται, όµως, σήµα αυξηµένου κινδύνου διαταραχών της συµπεριφοράς, κυρίως επιθετικότητας και εχθρικών αντιδράσεων.
Polish: CHMP uznał, że w badaniach z udziałem atomoksetyny nie wystąpiły oznaki zwiększonego ryzyka wystąpienia zachowań samobójczych, wystąpiły jednak oznaki zwiększonego ryzyka nieprawidłowości w zachowaniu przy zwiększonym poziomie skutków w postaci agresji i wrogości.
Greek: Λιθουανία SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Polish: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Greek: Ουγγαρία Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Polish: Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Greek: Γερµανία Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Polish: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Greek: Ολλανδία GenRx B.V.
Polish: GenRx B.V.
Greek: Medochemie Ltd, P.O.
Polish: Medochemie Ltd., 1-10
Greek: Πορτογαλία toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Polish: Portugalia toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Greek: Przemyslowa, PL - 35 959 Rzeszow
Polish: ICN Polfa Rzesów S.A., ul. Przemyslowa, PL - 35 959 Rzeszow
Greek: Przemyslow 2, 35-959 Rzeszow, Poland
Polish: ICN Polfa Rzeszow, ul. Przemyslow 2, 35-959 Rzeszow, Poland
Greek: Táncsics Mihály út 82, H-2100
Polish: Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Greek: Λιθουανία Ranbaxy (UK) Ltd., C.P.
Polish: Ranbaxy (UK) Ltd., C.P.
Greek: 1-5, 1045 Budapest, Hungary.
Polish: Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
Greek: Αυστρία Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Polish: Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Greek: SOLVAY PHARMA, S.A., Avda.
Polish: Hiszpania SOLVAY PHARMA, S.A., Avda.
Greek: Αυστρία GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Polish: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Greek: PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Polish: Hiszpania PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Greek: LABORATORIOS DR. ESTEVE, S.A., Avda.
Polish: Hiszpania LABORATORIOS DR. ESTEVE, S.A., Avda.
Greek: Rue-de-la-Pastorale 26-28
Polish: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Greek: Πολωνία Wyeth-Lederle Pharma GmbH, Storchengasse 1/3, A-1150 Wiedeń, AT
Polish: Wyeth-Lederle Pharma GmbH, Storchengasse 1/3, A-1150 Wiedeń, AT
Greek: Επίσης, δεν υπάρχουν µέχρι σήµερα µεγάλης διάρκειας στοιχεία ασφάλειας του [επινοηθείσα ονοµασία] όσον αφορά τη σωµατική ανάπτυξη, την ωρίµανση, τη διανοητική ανάπτυξη και την ανάπτυξη της συµπεριφοράς αυτής της ηλικιακής οµάδας.
Polish: Ponadto, jak do tej pory brak jest danych dotyczących długoterminowego bezpieczeństwa stosowania [nazwa handlowa] w tej grupie wiekowej dotyczących wzrostu, dojrzewania oraz rozwoju poznawczego i rozwoju zachowania.
Greek: Πόσιµες σταγόνες, διάλυµα
Polish: Krople doustne, roztwór
Greek: Πολωνία Gerot Pharmazeutika GmbH, Arnethgasse 3, A-1160 Vienna
Polish: Gerot Pharmazeutika GmbH, Arnethgasse 3, A-1160 Vienna
Greek: Σηµείωση: Το παρόν τµήµα του Φυλαδίου Οδηγιών αποτελούσε παράρτηµα της Απόφασης της Επιτροπής σχετικά µε το παραπεµπτικό σύµφωνα µε το ΄Αρθρο 31.Το κείµενο ήταν τότε έγκυρο.
Polish: Uwaga: Niniejszy dział ulotki dla pacjenta jest tym, który został dołączony w formie aneksu do decyzji Komisji na podstawie odwołania do art.31.
Greek: Λουξεµβούργο GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Polish: Luksemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Greek: Λουξεµβούργο ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Polish: Luksemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Greek: Σουηδία Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 DE90449 Nürnberg Tyskland (DEU)
Polish: Generica KG Südwestpark 50 DE90449 Nürnberg Tyskland (DEU)
Greek: 208-214 York Road, London SW11 3SD;
Polish: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Greek: Πολωνία GlaxoSmithKline Export Ltd., 980 Great West Road, TW8 9GS Brendford, Middlesex, UK
Polish: GlaxoSmithKline Export Ltd., 980 Great West Road, TW8 9GS Brendford, Middlesex, UK
Greek: Σουηδία Wyeth Lederle Nordiska AB Box 1822 171 24 Solna Sverige (SWE)
Polish: Wyeth Lederle Nordiska AB Box 1822 171 24 Solna Sverige (SWE)
Greek: Πορτογαλία Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Polish: Portugalia Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Greek: Ολλανδία KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Polish: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Greek: Γερµανία Woerwag Pharma GmbH & Co. KG Postfach 2129
Polish: Woerwag Pharma GmbH & Co. KG Postfach 2129
Greek: Καψάκιο παρατεταµένης αποδέσµευσης
Polish: Kapsułka o przedłużonym uwalnianiu
Greek: Ουγγαρία Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Polish: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Greek: Λιθουανία Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Polish: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Greek: Νορβηγία Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Polish: Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Greek: Η CHMP ήταν σύµφωνη ότι υφίσταται εν δυνάµει προειδοποιητικό σήµα για αύξηση στην αυτοκτονική συµπεριφορά, στις απόπειρες αυτοκτονίας, καθώς και στον αυτοκτονικό ιδεασµό και/ή σε παρεµφερείς συµπεριφορές, όπως αυτοτραυµατισµός, εχθρική συµπεριφορά και συναισθηµατική αστάθεια σε παιδιά και εφήβους που λαµβάνουν ΕΑΕΣ και ΑΕΣΝ.
Polish: CHMP przyznał, że występują potencjalne oznaki wzrostu liczby zachowań samobójczych, w tym prób samobójczych oraz wyobrażeń samobójczych i/lub powiązanych zachowań, takich jak autoagresja, wrogość oraz labilność nastroju u dzieci i młodzieży leczonych SSRI oraz SNRI.
Greek: Λουξεµβούργο PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Polish: Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Greek: Σουηδία NV Organon P O Box 20 NL-5340 BH Oss Nederländerna (NLD)
Polish: NV Organon P O Box 20 NL-5340 BH Oss Nederländerna (NLD)
Greek: Κράτος µέλος Κάτοχος της άδειας κυκλοφορίας Επινοηθείσα ονοµασία Περιεκτικότητα Φαρµακοτεχνική µορφή Οδός χορήγησης Πορτογαλία Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Polish: Portugalia Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
Greek: Σουηδία Medis Danmark A/S H. C. Andersens Boulevard 2 DK-1780 Köpenhamn Danmark (DNK)
Polish: Medis Danmark A/S H. C. Andersens Boulevard 2 DK-1780 Köpenhamn Danmark (DNK)
Greek: Φινλανδία Laboratoires SMB S.A., Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium
Polish: Laboratoires SMB S.A., Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium
Greek: Σουηδία Ranbaxy (UK) Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Polish: Ranbaxy (UK) Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Greek: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Polish: Hiszpania TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Greek: Έγχυση
Polish: Zawiesina
Greek: ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022 Barcelona, Spain
Polish: Hiszpania ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022
Greek: Σλοβακία Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Polish: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Greek: Urtinsa II 28923 Alcorcón, Spain
Polish: Pol. Ind. Urtinsa II 28923 Alcorcón, Spain
Greek: Πορτογαλία Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Polish: Portugalia Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Greek: Ολλανδία Hexal B.V.
Polish: Hexal B.V.
Greek: Ολλανδία Genthon B.V.
Polish: Genthon B.V.
Greek: Κράτος µέλος Κάτοχος της άδειας κυκλοφορίας Επινοηθείσα ονοµασία Περιεκτικότητα Φαρµακοτεχνική µορφή Οδός χορήγησης Γερµανία Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
Polish: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
Greek: MUNDOGEN FARMA, S.A., Severo Ochoa, 2, Tres Cantos 28760, Spain
Polish: Hiszpania MUNDOGEN FARMA, S.A., Severo Ochoa, 2, Tres Cantos 28760, Spain
Greek: Ιρλανδία Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland
Polish: Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland
Greek: ΣΙΤΑΛΟΠΡΑΜΗ,
Polish: ESCITALOPRAMU,
Greek: A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Polish: Hiszpania A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Greek: Kubickiego 11, 02-954 Warszawa, Poland
Polish: Ranbaxy (Poland) Sp. z o.o., ul. Kubickiego 11, 02-954 Warszawa, Poland
Greek: LAREQ PHARMA S.L, Laguna, 4244.
Polish: Hiszpania LAREQ PHARMA S.L, Laguna, 4244.
Greek: Πορτογαλία Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Polish: Portugalia Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Greek: Γερµανία Temmler Pharma GmbH & Co.KG Postfach 2269
Polish: Temmler Pharma GmbH & Co.KG Postfach 2269
Greek: Φινλανδία Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124 SOLNA, Sweden
Polish: Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124 SOLNA, Sweden
Greek: Σουηδία Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Polish: Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Greek: Λιθουανία Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Polish: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Greek: QUALIX PHARMACEUTICALS, S.A., Sardenya, 350, Barcelona 08025, Spain
Polish: Hiszpania QUALIX PHARMACEUTICALS, S.A., Sardenya, 350, Barcelona 08025, Spain
Greek: PFIZER, S.A., Avda.
Polish: Hiszpania PFIZER, S.A., Avda.
Greek: Πορτογαλία Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Polish: Portugalia Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Greek: Λουξεµβούργο EUROGENERICS N.V.
Polish: Luksemburg EUROGENERICS N.V.
Greek: ΠΑΡΑΡΤΗΜΑ ΙΙΙ ΤΡΟΠΟΠΟΙΗΣΕΙΣ ΣΤΗΝ ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
Polish: ZAŁĄCZNIK III ZMIANY W CHARAKTERYSTYCE PRODUKTU LECZNICZEGO
Greek: USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain
Polish: Hiszpania USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain
Greek: Box 20, Oss, Netherland
Polish: Organon, P.O. Box 20, Oss, Netherland
Greek: Αυστρία F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Polish: F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Greek: 2 SΝRI σηµαίνει αναστολέας της «επαναπρόσληψης σεροτονίνης-νορεπινεφρίνης (ΑΕΣΝ)».
Polish: Skrót SNRI oznacza „Selektywny inhibitor wychwytu zwrotnego serotoniny i noraderenaliny".
Greek: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Polish: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Greek: USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid 28008, Spain
Polish: Hiszpania USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid 28008, Spain
Greek: Σλοβακία Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Polish: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Greek: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU;
Polish: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Greek: Νορβηγία Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
Polish: Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
Greek: Ουγγαρία Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
Polish: Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
Greek: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Polish: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
Greek: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Polish: Hiszpania LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Greek: Σλοβακία Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Polish: Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Greek: PENSA, S.A., Avda.
Polish: Hiszpania PENSA, S.A., Avda.
Greek: Ιρλανδία Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hertfordshire, SG4 0TW, UK
Polish: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hertfordshire, SG4 0TW, UK
Greek: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Polish: Hiszpania LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Greek: Ουγγαρία Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Polish: Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Greek: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW;
Polish: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Greek: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Polish: Hiszpania LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Greek: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain
Polish: Hiszpania LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain