FrancophonIA/ELRC3.0 huggingface dataset:
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Latvian: Latvian JSC Grindeks, Krustpils ul.
English: House,
Latvian: P. House,
English: N.V. Organon Molenstraat 110.
Latvian: Organon Molenstraat 110.
English: Netherlands Niche Generics Ltd. 1 The Cam Centre
Latvian: Nīderlande Niche Generics Ltd. 1 The Cam Centre
English: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Latvian: Portugāle Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Latvian: Tikai dažas no šīm zālēm ir atļautas, lai ārstētu bērnus un pusaudžus, kuriem ir apmātības piespiedu traucējumi vai arī viens no tiem attiecībā uz uzmanības deficīta/hiperaktivitātes traucējumiem.
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Latvian: Izpētes pārsvarā attiecās uz pacientiem ar smagiem depresīviem traucējumiem (MDD), bet dažas - uz pacientiem ar dažādiem trauksmes traucējumiem (apmātības piespiedu traucējums (OCD), vispārējās trauksmes traucējums (GAD) un sociālās trauksmes traucējums (SAD)).
English: These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
Latvian: Visā Eiropas teritorijā šīs zāles nav atļautas, lai ārstētu bērnu vai pusaudžu traucējumus - depresiju vai trauksmi.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Latvian: Bez tam trūkst datu par nekaitīgumu bērniem un pusaudžiem ilgstošā laikā, tostarp ietekmi uz augšanu, nobriešanu, kognitīvo un uzvedības attīstību.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Latvian: Pārbaudot uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību, konstatēja, ka nevienā no pārskatītajām izpētēm netika norādīts uz izdarītām pašnāvībām.
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Latvian: Pēc Komisijas pieņemtā lēmuma dalībvalstu kompetentās iestādes sniegs jaunāko informāciju par atbilstošajām zālēm.
English: Winthrop Farmacêutica Portugal, Lda.
Latvian: Portugāle Winthrop Farmacêutica Portugal, Lda.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Latvian: Ja, ņemot vērā klīnisko nepieciešamību, tiek pieņemts lēmums uzsākt šo ārstēšanu, pacients ir rūpīgi jāuzrauga, lai savlaicīgi konstatētu uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību.
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Latvian: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
English: St. Stephens Green, Dublin 2 Ireland
Latvian: Stephens Green, Dublin 2 Ireland
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Latvian: [Piešķirtais nosaukums] nav indicēts nopietnu depresīvo pazīmju un/vai trauksmes ārstēšanai, jo ar pieaugušajiem veiktās klīniskās izpētes rezultāti nav uzrādījuši nekādas blakusparādības, salīdzinot ar placebo metodes izmantošanu, un tādēļ bija negatīvi.
English: Michała 67/71, 61-005 Poznań, Poland
Latvian: Św. Michała 67/71, 61-005 Poznań, Poland
English: Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
Latvian: Portugāle Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
English: Corporation Eesti, Pirita tee 20, 10127 TALLINN, Estonia
Latvian: P. Corporation Eesti, Pirita tee 20, 10127 TALLINN, Estonia
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Latvian: [Piešķirtais nosaukums] nevajadzētu lietot bērniem un pusaudžiem, kas ir jaunāki par 18 gadiem <izņemot pacientiem ar [apstiprinātā indikācija]>.
English: Vetiquima - Produtos Químicos, Lda.
Latvian: Portugāle Vetiquima - Produtos Químicos, Lda.
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Latvian: 1 SSRI ir “Serotonīna selektīvie atpakaļuzņemšanas inhibitori”.
English: Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
Latvian: Portugāle Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
English: Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
Latvian: Portugāle Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Latvian: Komiteja arī secināja, ka atomoksetīnam, kas ir indicēts ADHD ārstēšanai, būtu piemērotāks atšķirīgs brīdinājums.
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Latvian: Tika izskatīti iegūtie dati, kurus kompetentajām iestādēm iesniedza, veicot īstermiņa placebo (tukšā parauga metode) metodes kontrolētās izlases klīniskās izpētes, izlases klīniskās izpētes, kuras publicētas medicīniskajā literatūrā, zāļu lietošanas novērojumus, kā arī ekoloģiskos pētījumus.
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Latvian: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Netherlands Merck Generics BV Dieselweg 25
Latvian: Nīderlande Merck Generics BV Dieselweg 25
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Latvian: Pacienti, kas ir jaunāki par 18 gadiem, biežāk cieš no blakusparādībām, piemēram, naidīgums (galvenokārt agresivitātes, opozicionāra uzvedība un dusmas), kā arī emocionālas labilitātes.
English: Pfizer H.C.P.
Latvian: Pfizer H.C.
English: Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
Latvian: Portugāle Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Latvian: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Latvian: Sākotnējā pārskatā par valstu kompetentajām iestādēm pieejamajiem datiem CHMP secināja, ka ir pamats bažām par bērniem attiecībā uz biežāk sastopamu uzvedību, kas liecina par tieksmi uz pašnāvību.
English: Suspension
Latvian: Suspensija
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Latvian: CHMP izskatīja MAH iesniegtos datus par pazīmēm bērnu un pusaudžu uzvedībā saistībā ar tieksmi uz pašnāvību.
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
Latvian: CHMP uzskata, ka atomoksetīna izpētēs nav konstatētas pazīmes, kas liecinātu par palielinātu risku attiecībā uz pašnāvības tieksmes uzvedības pazīmēm, tomēr bija pazīme par palielinātu risku saistībā ar uzvedības pazīmēm, kuras apstiprina biežākas agresivitātes un naidīguma izpausmes.
English: Jelfa S.A. Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
Latvian: Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
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]>.
Latvian: [Piešķirtais nosaukums] nevajadzētu lietot ārstējot bērnus un pusaudžus, kas ir jaunāki par 18 gadiem <izņemot [apstiprinātā indikācija ] pacientus ar >.
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Latvian: Nīderlande Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Latvian: Portugāle Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
English: Em, 1075 Budapest, Hungary.
Latvian: VII. Em, 1075 Budapest, Hungary.
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Latvian: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Latvian: Nīderlande Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: Wyeth Medica Ireland - Little Connell, Newbridge, Co. Kildare, (Ireland)
Latvian: Wyeth Medica Ireland - Little Connell, Newbridge, Co.
English: Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Latvian: Portugāle Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
English: Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Latvian: Portugāle Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Latvian: Portugāle Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
English: Alternova AS, Holmengata 24, NO1394 Nesbru, Norway
Latvian: Norvēģija Alternova AS, Holmengata 24, NO1394 Nesbru, Norway
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Latvian: Nīderlande Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Latvian: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Latvian: PIELIKUMS I ZĀĻU PIEŠĶIRTO NOSAUKUMU, FARMACEITISKO FORMU, ZĀĻU STIPRUMA, LIETOŠANAS VEIDU UN REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKU SARAKSTS DALĪBVALSTĪS
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Latvian: Nīderlande Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Latvian: Nīderlande Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Latvian: Portugāle Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
English: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Latvian: Portugāle Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
English: Lange Munteplein 7b 4, 8500
Latvian: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: N.V. Organon, P.O.
Latvian: Organon, P.O.
English: Remeron 3mg/mlKonzentrat zur Herstellung einer Infusionslösung
Latvian: Remeron 3mg/ml-Konzentrat zur Herstellung einer Infusionslösung
English: Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Latvian: Portugāle Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Latvian: Nīderlande Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Belgium OLYMPO PHARMA B.V.B.A.
Latvian: OLYMPO PHARMA B.V.B.A.
English: Lundbeck ( Ireland ) Limited, 14 Deansgrange Industrial Estate, Blackrock, Co. Dublin, Ireland
Latvian: Lundbeck ( Ireland ) Limited, 14 Deansgrange Industrial Estate, Blackrock, Co.
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Latvian: Nīderlande AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Latvian: Piezīme: Šī zāļu apraksta sadaļa, saskaņā ar 31. pantu, tika pievienota Komisijas lēmuma par izskatīšanas pieteikumiem pielikumā.
English: Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Latvian: Portugāle Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
English: As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Latvian: Bez tam nevar izslēgt retu, nopietnu psihisku blakusparādību attīstību.
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
Latvian: Portugāle Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Latvian: Bez tam Jums ir jāzina, ka pacienti, kas ir jaunāki par 18 gadiem, lietojot šīs klases zāles biežāk cieš no blakusparādībām, piemēram, pašnāvības mēģinājumiem, domām par pašnāvību un naidīguma (galvenokārt agresivitātes, opozicionāras uzvedības un dusmām).
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Latvian: Portugāle Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Latvian: Nīderlande Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Latvian: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Latvian: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Latvian: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
Latvian: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co.
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Latvian: Nīderlande Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
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;
Latvian: Tā kā - Komiteja uzskata, ka atsauce saskaņā ar 31. pantu Direktīvā 2001/83/EK ir grozīta attiecībā uz zālēm, kuras satur atomoksetīnu, citalopramu, escitalopramu, fluoksetīnu, fluvoksamīnu, mianserīnu, milnacipranu, mirtazapīnu, paroksetīnu, reboksetīnu, sertralīnu un venlafaksīnu;
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Latvian: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Latvian: Nīderlande ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Latvian: Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Latvian: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Latvian: Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Latvian: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Latvian: Portugāle Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Latvian: Nīderlande GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Via Livornese, 897 La Vettola 56010 Pisa Italy
Latvian: Laboratori Guidotti S.p.A. Via Livornese, 897 La Vettola 56010 Pisa Italy
English: Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Latvian: Portugāle Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S.
English: Eli Lilly Nederland BV Postbus 379
Latvian: Nīderlande Eli Lilly Nederland BV Postbus 379
English: Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal
Latvian: Portugāle Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089
English: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Latvian: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX;
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Latvian: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Latvian: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Latvian: Portugāle Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
English: LABORATORIOS RUBIO, S.A., Industria 29 - Pol. Ind. Comte de Sert.
Latvian: LABORATORIOS RUBIO, S.A., Industria 29 - Pol.
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Latvian: WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Latvian: Nīderlande Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Latvian: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Latvian: Tomēr izpētēs par depresiju tika konstatēti skaidri pierādījumi par uzvedības pazīmēm, kas liecina par tieksmi uz pašnāvību, bet izpētēs par trauksmi šīs pazīmes bija mazāk izteiktas.
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Latvian: Nīderlande Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Latvian: Nīderlande Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Latvian: Portugāle Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
English: Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Latvian: Portugāle Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Latvian: Portugāle Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
English: Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Latvian: Norvēģija Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Latvian: Portugāle Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Via Licino, 11-13-15 Erba 22036 Como Italy
Latvian: Lisapharma S.p.A. Via Licino, 11-13-15 Erba 22036 Como Italy
English: Via di Scandicci, 37 50143 Firenze Italy
Latvian: S.p.A. Via di Scandicci, 37 50143 Firenze Italy
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Latvian: Nīderlande Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Latvian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Latvian: Ja kāda no iepriekš uzskaitītajām pazīmēm pastiprinās vai tā kļūst izteiktāka pēc ārstēšanas sākuma, informējiet savu ārstu.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Latvian: III PIELIKUMS GROZĪJUMI, KAS ATTIECAS UZ ZĀĻU APRAKSTU
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Latvian: Nīderlande Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Latvian: Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
English: Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Latvian: Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. VIA LICINIO 11
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Latvian: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: Ranbaxy (UK) Ltd, 6rd floor,C.P.
Latvian: Ranbaxy (UK) Ltd, 6rd floor,C.
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
Latvian: Piezīme: Zāļu lietošanas instrukcijas sadaļa, sasakaņā ar 31. pantu, tika pievienota Komisijas lēmuma par izskatīšanas pieteikumiem pielikumā.
English: B.V. Postbus 75
Latvian: Postbus 75
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Latvian: Nīderlande Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
Latvian: Norvēģija GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Latvian: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Latvian: Avenue Mercator 1 1300 Wavre, Belgium
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Latvian: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Latvian: Norvēģija Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
Latvian: Pharmaceutical Works Polpharma S.A., ul.
English: IIP-Institut fuer industrielle Pharmazie Benzstr.
Latvian: IIP-Institut fuer industrielle Pharmazie Benzstr. 2 a
English: Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Latvian: Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal