natgillin/translations-raw huggingface dataset:
Cinryze is available as a powder and solvent that are made up into a solution for injection into a vein. 
Zdravilo Cinryze je prašek in vehikel za pripravo raztopine za injiciranje.
The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure. 
Družba je predložila tudi podatke o uporabi zdravila Cinryze pri 91 bolnikih za preprečevanje napadov pred zdravniškim, zobozdravstvenim ali kirurškim posegom.
Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema. 
Zdravilo Cinryze se uporablja za zdravljenje napadov angioedema (otekanja) pri odraslih in mladostnikih, starih od 12 do 17 let, z dednim angioedemom.
For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure. 
Za preprečevanje napadov otekanja pred zdravniškim, zobozdravstvenim ali kirurškim posegom se zdravilo Cinryze daje v odmerku 1 000 enot do 24 ur pred posegom.
In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients. 
V eni glavni študiji so zdravilo Cinryze in placebo (zdravilo brez zdravilne učinkovine) uporabili za zdravljenje napadov angioedema pri 71 bolnikih z dednim angioedemom.
How does Cinryze work? 
Kako zdravilo Cinryze deluje?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinryze have also been included in the summary of product characteristics and the package leaflet. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so vključeni tudi priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo tega zdravila.
How is Cinryze used? 
Kako se zdravilo Cinryze uporablja?
For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack. 
Pri zdravljenju napadov angioedema bolnik prejme 1 000 enot ob prvem znaku napada.
Cinryze contains the active substance C1 inhibitor (human). 
Vsebuje zdravilno učinkovino zaviralec C1 (humani).
What is Cinryze and what is it used for? 
Za kaj se zdravilo Cinryze uporablja?
Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults. 
Zdravilo Cinryze je bilo učinkovitejše od placeba pri zdravljenju in preprečevanju napadov angioedema.
Cinryze can only be obtained with a prescription. 
Zdravilo Cinryze se daje z injiciranjem v veno.
The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days. 
Za preprečevanje napadov se zdravilo Cinryze daje v odmerku 1 000 enot vsake tri ali štiri dni.
Therefore, this wording may not necessarily represent the current text. 
Zaradi tega je možno, da ta zapis ne predstavlja trenutno veljavnega besedila.
Following the review of the data available to the national competent authorities, the European Commission triggered an article 31 of Directive 2001/83/EC, as amended, on 17 December 2004. 
Po pregledu podatkov, dostopnih nacionalnim pristojnim organom, je Evropska komisija sprožila postopek v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena 17. decembra 2004.
This signal was present in all products for which studies were available, and from the available evidence it could not be excluded that this signal would be class related. 
Ta signal je prisoten pri vseh zdravilih, za katera so bile dostopne raziskave, in iz dostopnih dokazov ni bilo mogoče izključiti, da je ta signal povezan s skupinami zdravil.
As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded. 
Kot pri drugih psihotropnih zdravilih ni možno izključiti možnosti redkih, hudih psihiatričnih neželenih učinkov.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. 
Poleg tega manjkajo podatki o varnosti na dolgi rok pri otrocih in mladostnikih v zvezi z rastjo, odraščanjem, kognitivnim in vedenjskim razvojem.
If your doctor has prescribed [Invented Name] for a patient under 18 and you want to discuss this, please go back to your doctor. 
Če je vaš zdravnik predpisal zdravilo [izmišljeno ime] za bolnika, mlajšega od 18 let, in se želite pogovoriti o tem, se vrnite k zdravniku.
However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies. 
Vendar je bil ugotovljen jasen signal s samomori povezanih vedenj v raziskavah depresije in manj močen signal v raziskavah anksioznosti.
These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents. 
Ta zdravila v vsej Evropi niso dovoljena za zdravljenje depresivnih in anksioznih motenj pri otrocih in mladostnikih.
The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD. 
Odbor je zaključil tudi, da je za atomoksetin primernejše drugačno opozorilo, ki je edino zdravilo indicirano za zdravljenje ADHD.
Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI 
Na prošnjo iz Evropske komisije je Odbor za zdravila za uporabo v humani medicini pregledal podatke iz kliničnih preskušanj, ki so bila dostopna nacionalnim pristojnim organom, za naslednja zdravila iz skupine SSRI
Lilly Hungary Kft., Madách Imre út 13-15. 
Madžarska Lilly Hungary Kft., Madách Imre út 13-15.
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. 
Le nekaj teh zdravil je dovoljenih za zdravljenje otrok in mladostnikov z obsesivnokompulzivnimi motnjami in/ali eno izmed njih pa za zdravljenje motnje pomanjkanja pozornosti in hiperaktivnosti.
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. 
Pregledani podatki so vsebovali krajša, s placebom nadzorovana randomizirana preskušanja, ki so bila predložena pristojnim organom, randomizirana klinična preskušanja, ki so objavljena v medicinski literaturi, opazovalne raziskave in ekološke raziskave.
Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies. 
Pri pregledu s samomori povezanih vedenj se je izkazalo, da v nobeni raziskavi ni bilo ugotovljenih izvršenih samomorov.
Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability. 
Bolnike, pri katerih uvedete zdravljenje ADHD, morate natančno spremljati za pojav ali poslabšanje sovražnosti in čustvene labilnosti.
Netherlands I.C.C. 
Nizozemska I.C.C.
Teva Gyógyszergyár Rt., Pallagi útca. 
Madžarska Teva Gyógyszergyár Rt., Pallagi útca.
Netherlands Niche Generics Ltd. 1 The Cam Centre 
Nizozemska Niche Generics Ltd. 1 The Cam Centre
Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. 
Portugalska Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Winthrop Farmacêutica Portugal, Lda. 
Portugalska Winthrop Farmacêutica Portugal, Lda.
SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin. 
Zdravila SSRI poimenujemo „selektivna“, ker učinkujejo le na črpalke za ponovni prevzem, ki so specifične za serotonin.
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)). 
Večina preskušanj je zajela bolnike s motnjami velike depresije (MDD), nekaj preskušanj pa tudi bolnike z raznimi anksioznimi motnjami (obsesivnokompulzivna motnja (OCD)), generalizirana anksiozna motnja (GAD), socialna anksiozna motnja (SAD)).
[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. 
Zdravilo [izmišljeno ime] ni indicirano za zdravljenje epizod velike depresije in/ali anksioznosti, saj rezultati opravljenih kliničnih preskušanj pri odraslih niso pokazali nobenega učinka v primerjavi s placebom in so zato bili negativni.
[Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>. 
Zdravilo [izmišljeno ime] se običajno ne sme uporabiti za otroke in mladostnike, mlajše od 18 let <razen pri bolnikih z [odobreno indikacijo]>.
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. 
Po predhodnem pregledu podatkov, dostopnih nacionalnim pristojnim organom, je Odbor za zdravila za uporabo v humani medicini zaključil, da obstaja podlaga za zaskrbljenost glede porasta s samomori povezanih vedenj pri otrocih.
Glaxo Smith Kline Kft., Csörsz u. 43. 
Madžarska Glaxo Smith Kline Kft., Csörsz u. 43.
Vetiquima - Produtos Químicos, Lda. 
Portugalska Vetiquima - Produtos Químicos, Lda.
1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'. 
1 SSRI pomeni „Serotonin-Selective Reuptake Inhibitor“ [zaviralec ponovnega prevzema, ki je selektiven za serotonin].
Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda., 
Portugalska Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal 
Portugalska Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
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 
PRILOGA 1 SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA 
PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova 
Nizozemska Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability. 
Bolniki, mlajši od 18 let, imajo povečano tveganje za neželene učinke, npr. sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jezo) ter čustveno labilnost.
Pol. Emp. La Marina. 
Pol. Emp.
Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests. 
Kljub temu, lahko vaš zdravnik predpiše zdravilo [izmišljeno ime] za bolnike, mlajše od 18 let, če se odloči, da je to najbolje za bolnika.
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. 
Vedeti morate tudi, da imajo bolniki, mlajši od 18 let, večje tveganje za neželene učinke, npr. poskus samomora, samomorilne misli in sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jezo), ko jemljejo zdravila iz te skupine.
Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal 
Portugalska Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral . 
Opomba: Ta razdelek Povzetka glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated. 
Poleg tega za zdravilo [izmišljeno ime] še niso dokazani varnostni učinki na dolgi rok v zvezi z rastjo, odraščanjem, kognitivnim in vedenjskim razvojem v tej starostni skupini.
Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal 
Portugalska Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
Netherlands Merck Generics BV Dieselweg 25 
Nizozemska Merck Generics BV Dieselweg 25
In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD). 
Nekaj dodatnih raziskav je zajelo bolnike z motnjo pomanjkanja pozornosti in hiperaktivnostjo (ADHD).
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. 
Odbor za zdravila za uporabo v humani medicini je mnenja, da v raziskavah atomoksetina ni bilo signala povečanega tveganja s samomori povezanih vedenj, vendar obstaja povečano tveganje nenormalnega vedenja z več učinki nasilnega vedenja in sovražnosti.
IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany 
Madžarska IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal 
Portugalska Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
[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]>. 
Zdravila [izmišljeno ime] ne smete uporabiti za zdravljenje otrok in mladostnikov, mlajših od 18 let <razen pri bolnikih z [odobreno indikacijo]>.
Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület 
Madžarska Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
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. 
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.
Chinoin, Tó u. 1-5, 1045 Budapest, Hungary. 
Madžarska Chinoin, Tó u. 1-5, 1045 Budapest, Hungary.
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. 
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.
Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary 
Madžarska Teva Gyógyszergyár Rt., Pallagi útca 13,.Debrecen, Hungary
Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal 
Portugalska Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral . 
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.
Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts 
Nizozemska Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary 
Madžarska Lundbeck Hungária Kft, Montevideó utca 3/B, 1037, Budapest, Hungary
Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal 
Portugalska Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest 
Nizozemska Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld 
Nizozemska Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary 
Madžarska Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100
Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK 
Velika Britanija Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht 
Nizozemska Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal 
Portugalska Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal 
Portugalska Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents. 
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.
Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands 
Nizozemska Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal 
Portugalska Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal 
Portugalska Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal 
Portugalska Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal 
Portugalska Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary 
Madžarska Hexal Hungária Kft., Tímár u. 20, 1034 Budapest, Hungary
Remeron 3mg/mlKonzentrat zur Herstellung einer Infusionslösung 
Remeron 3mg/ml-Konzentrat zur Herstellung einer Infusionslösung
Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal 
Portugalska Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren 
Nizozemska AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal 
Portugalska Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary 
Madžarska Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel 
Nizozemska Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal 
Portugalska Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal 
Portugalska Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 
Nizozemska Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Eli Lilly Nederland BV Postbus 379 
Nizozemska Eli Lilly Nederland BV Postbus 379
SNRIs work on the norepinephrine and serotonin neurotransmitters 
Zdravila SNRI učinkujejo na živčna prenašalca norepinefrin in serotonin.
Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn 
Nizozemska ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209 Carnaxide Portugal 
Portugalska Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209
Capsule, soft 
Kapsula, mehka
MOM Park Gesztenyés torony, 1124 Budapest, Hungary 
MOM Park Gesztenyés torony, 1124
Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven 
Nizozemska GenRx B.V., Postbus 75, NL-6920 AB Duiven
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