natgillin/translations-raw huggingface dataset:
Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal
Portugalska Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089
IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
IV.2 DOPOLNILA, KI SE VKLJUČIJO V ZADEVNO POGLAVJE NAVODILA ZA UPORABO ZA ATOMOKSETIN
Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Portugalska Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S.
2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
2 SNRI pomeni „Serotonin-Norepinephrine Reuptake Inhibitor“ [zaviralec ponovnega prevzema serotonina in norepinefrina].
Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Nizozemska Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Portugalska Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Nizozemska Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Portugalska Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Portugalska Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Nizozemska Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Nizozemska Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Portugalska Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Madžarska Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Portugalska Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Nizozemska Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Nizozemska Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Nizozemska Hexal AG, Postfach 1263, D-83602 Holzkirchen
Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Nizozemska Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Nizozemska Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Portugalska Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Portugalska Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Madžarska Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Nizozemska Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Madžarska Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Portugalska Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Portugalska Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Nizozemska Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
D-64206 Darmstadt paroxedura 30 mg Filmtabletten
D-64206 Darmstadt paroxedura 30 mg Filmtabletten 30 mg
Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Nizozemska Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Remeron 15mg/mlLösung zum Einnehmen
Remeron 15mg/ml-Lösung zum Einnehmen
Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
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.
Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Portugalska Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Nizozemska Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Nizozemska Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Velika Britanija Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Nizozemska Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Luksemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Portugalska Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Portugalska ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Portugalska Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Nizozemska Hexal B.V., Postbus 251, NL-2180 AG Hillegom
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.
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.
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
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.
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.
Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Portugalska Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Če se po uvedbi zdravljenja pojavi ali poslabša katerikoli od zgoraj navedenih simptomov, morate obvestiti svojega zdravnika.
ORAL SOLUTION
Prozit Oral Solution
D-64206 Darmstadt paroxedura 20 mg Filmtabletten
D-64206 Darmstadt paroxedura 20 mg Filmtabletten 20 mg
Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Luksemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Nizozemska Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Concentrate for solution for injection
Koncentrat za pripravo raztopine za injiciranje
Fluvoxaminmaleat “Solvay” 50mgFilmtabletten
Fluvoxaminmaleat “Solvay” 50mg-Filmtabletten
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
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.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Velika Britanija Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
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;
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;
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Nizozemska Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Remergil 15 mg/5ml Konzentrat
Remergil 15 mg/5ml Konzentrat 15 mg
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Nizozemska Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Seroxat 2mg/ml-orale Lösung
Seroxat 2mg/ml-orale Lösung 2mg/ml
Inpharmco-Mianserin30mg-Tabletten
Inpharmco-Mianserin-30mgTabletten
Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Portugalska toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Portugalska Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Nizozemska KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Madžarska Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Nizozemska Alfred Tiefenbacher (GmbH & Co.
Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Portugalska toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Madžarska Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Nizozemska Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
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.
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.
Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Madžarska Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Portugalska Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Paroxetin “Salutas” 40mg-Filmtabletten
Paroxetin “Salutas” 40mgFilmtabletten
Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Portugalska Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
2696-901 Bobadela Portugal
Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Portugalska Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
Remeron 15 mg/ml, oral solution
Remeron 15 mg/ml, oral solution 15 mg/ml
- 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;
- 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;
Inpharmco-Mianserin10mg-Tabletten
Inpharmco-Mianserin-10mgTabletten
Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Portugalska Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
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)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO FLUOKSETIN, FLUVOKSAMIN, SERTRALIN, PAROKSETIN, CITALOPRAM, ESCITALOPRAM, ATOMOKSETIN, VENLAFAKSIN, MIANSERIN, MILNACIPRAN, REBOKSETIN IN MIRTAZAPIN (glejte Prilogo I)
Paroxetin “Sandoz” 20mg-Tabletten
Paroxetin “Sandoz” 20mgTabletten
ZOLOFT OC 20mg/ml 20mg/ml
ZOLOFT OC 20mg/ml
Paroxetin “Merckle” 20mg-Filmtabletten
Paroxetin “Merckle” 20mgFilmtabletten
Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Portugalska Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Madžarska Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Portugalska Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
III.2 DOPOLNILA, KI SE VKLJUČIJO V ZADEVNO POGLAVJE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA ATOMOKSETIN
Oropharyngeal use
Orofaringealna uporaba
SEROXAT 30 MG 30 mg
SEROXAT 30 MG
PAROXETINA HEXAL 40 mg
PAROXETINA HEXAL 40 mg 40 mg
Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Madžarska Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Nizozemska Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Fluoxetin HEXAL 10mg Tabs
Fluoxetin HEXAL 10mg Tabs 10 mg
Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Madžarska Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Paroxetin “Arcana” 20mg-Filmtabletten
Paroxetin “Arcana” 20mgFilmtabletten
Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Portugalska Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Portugalska Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
EDRONAX 4 MG N
EDRONAX 4 MG
Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Portugalska Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
PAROXETINA APOTEX-FARMA
PAROXETINA APOTEXFARMA
Netherlands Centrafarm Services B.V. Postbus 289
Nizozemska Centrafarm Services B.V.
Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131 Algés Portugal
Portugalska Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Mirtazapin “Alternova” 45mg-Filmtabletten
Mirtazapin “Alternova” 45mgFilmtabletten
Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
Madžarska Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,.
- 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.
- 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.
Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal
Portugalska Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
SERTRALIN IREX 50 MG
SERTRALIN IREX 50 MG 50 mg
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.
, zlasti glede njihove uporabe pri otrocih: fluoksetin, fluvoksamin, sertralin, paroksetin, citalopram, escitalopram, atomoksetin, duloksetin, venlafaksin, mianserin, milnacipran, reboksetin in mirtazapin.
Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Zoloft 25 mg + 50 mg 25 mg + 50 mg
Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Madžarska Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Fluoxetine „Stada“ 20mg-Kapseln
Fluoxetine „Stada“ 20mgKapseln
Milnacipran Pierre Fabre 25 mg
Milnacipran Pierre Fabre
Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131 Algés Portugal
Portugalska Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
Mirtabene „ratiopharm“ 45mg-Filmtabletten
Mirtabene „ratiopharm“ 45mgFilmtabletten
Mirtazapin “Alternova” 30mg-Filmtabletten
Mirtazapin “Alternova” 30mgFilmtabletten
Dispersable tablet
Peroralna disperzibilna tableta
QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed 20 mg
QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed
Euro-Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
DALCIPRAN 25MG 25 mg
DALCIPRAN 25MG
Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Luksemburg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Paroxetin beta 20mg 20 mg
Paroxetin beta 20mg
Mirtazapine Sandoz 15 mg
MIRTAZAPINA SANDOZ 15 mg
Mirtazapin “Alternova” 15mg-Filmtabletten
Mirtazapin “Alternova” 15mgFilmtabletten
Fluoxetin-TEVA 10 mg Tabletten
Fluoxetin-TEVA 10 mg Tabletten 10 mg
Netherlands Katwijk Farma B.V. Postbus 408
Nizozemska Katwijk Farma B.V.
Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Nizozemska Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Madžarska Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Remeron 15 mg, tablets 15 mg
Remeron 15 mg, tablets
Paroxetina Apotex Europe 20 mg
Paroxetina Apotex Europe
Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Madžarska Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
20 mg/0,5 ml Concentrate for solution for infusion
20 mg/0,5 ml Koncentrat za pripravo raztopine za infundiranje
Mirtel 45mgFilmtabletten
Mirtel 45mg-Filmtabletten
Loxozapin 45 mg Filmtabletten
Loxozapin 45 mg Filmtabletten 45 mg
Netherlands GenRx B.V. Postbus 75
Nizozemska GenRx B.V.
Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Nizozemska H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
REXETIN 30MG 30mg
REXETIN 30MG
Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Velika Britanija Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338 Prior Velho Portugal
Portugalska Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Interfarma, Produtos Químicos e Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131 Algés Portugal
Portugalska Interfarma, Produtos Químicos e Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131 Algés Portugal
MIRTAZAPINA RATIOPHARM
Mirtazapin ratiopharm
Dalcipran 50mg-Kapseln 50mg
Dalcipran 50mg-Kapseln
Mirtel 15mgFilmtabletten
Mirtel 15mg-Filmtabletten
Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
Madžarska Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
Fluoxetin “Arcana” 20mg-Kapseln
Fluoxetin “Arcana” 20mgKapseln
DALCIPRAN 50MG 50 mg
DALCIPRAN 50MG
Remeron 30 mg, tablets 30 mg
Remeron 30 mg, tablets
Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Nizozemska Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Fluoxetine Bouchara Recordati
Fluoxetine Bouchara Recordati 20 mg
SEROXAT 20 MG 20 mg
SEROXAT 20 MG
Mirtel 30mgFilmtabletten
Mirtel 30mg-Filmtabletten
Prolonged release capsule, hard
Kapsula s podaljšanim sproščanjem, trda
Remeron 45 mg, tablets 45 mg
Remeron 45 mg, tablets
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten