FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).
Slovenian: V študijah, v katerih so uporabili režim zniževanja odmerka, so v času zniževanja odmerka ali po ukinitvi paroksetina poročali o naslednjih simptomih, ki so se pojavili vsaj pri 2 % bolnikov in vsaj dvakrat pogosteje kot pri placebu: čustvena labilnost (vključno z jokom, spreminjanjem razpoloženja, samouničevalnim obnašanjem, samomorilnimi mislimi in samomorilnimi poskusi), nervoznost, omotica, navzea in abdominalna bolečina (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Paroxetine does not impair psychomotor function and does not potentiate the depressant effects of ethanol.
Slovenian: Farmakodinamični učinki Paroksetin ne okvari psihomotoričnega delovanja in ne krepi sedativnih učinkov etanola.
English: However, there is some clinical data suggesting that up-titrating the dose might be beneficial for some patients.
Slovenian: Vendar pa nekateri klinični podatki kažejo, da je postopno višanje odmerka lahko pri določenih bolnikih koristno.
English: As these syndromes may result in potentially lifethreatening conditions, treatment with paroxetine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Slovenian: Ker lahko sindroma vodita v potencialno življenjsko nevarna stanja je, če se pojavijo takšni dogodki (značilni po skupini simptomov kot so hipertermija, rigidnost, mioklonus, avtonomna labilnost z mogočim hitrim spreminjanjem vitalnih znakov, spremembe mentalnega statusa vključno z zmedenostjo, razdražljivostjo, ekstremno agitacijo, ki progresira v delirij in komo), potrebno zdravljenje s paroksetinom ukiniti in uvesti podporno simptomatsko zdravljenje.
English: Rare: manic reactions, agitation, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4 Special Warnings and Special Precautions for use).
Slovenian: Redki: manične reakcije, agitacija, anksioznost, depersonalizacija, napadi panike, akatizija (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi) Ti simptomi so lahko tudi posledica osnovne bolezni.
English: In addition, in these trials efficacy has not been adequately demonstrated and long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8 Undesirable Effects).
Slovenian: Za otroke in mladostnike manjkajo tudi dolgoročni podatki o varnosti, ki zadevajo rast, dozorevanje in kognitivni ter vedenjski razvoj (glejte poglavje 4.8 Neželeni učinki).
English: Denmark GlaxoSmithKline Pharma A/S Nykær 68
Slovenian: GlaxoSmithKline Pharma A/S Nykær 68
English: SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA
Slovenian: SOCIALNA ANKSIOZNA MOTNJA/SOCIALNA FOBIJA
English: Based on the assessment of data from clinical trials and from post marketing the CHMP concluded that there is a possibility of an increased risk of suicidal related behaviour associated with paroxetine in young adults (18-29 years), even though the increased risk was not statistically significant.
Slovenian: Na podlagi ocene podatkov iz kliničnih preskušanj in poročil po uvedbi zdravila na trg so v CHMP zaključili, da obstaja možnost za povečano tveganje samomorilnega povezanega vedenja, povezanega s paroksetinom, pri mladih odraslih (18-29 let), čeprav povečano tveganje ni bilo statistično značilno.
English: Biara - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Biara - Produtos Farmacêuticos, Lda.
English: However, there are some clinical data suggesting that up-titrating the dose might be beneficial for some patients.
Slovenian: Kljub vsemu pa obstajajo nekateri klinični podatki, ki kažejo, da je povečevanje odmerka pri nekaterih bolnikih lahko koristno.
English: Merck Genéricos - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Merck Genéricos - Produtos Farmacêuticos, Lda.
English: Rue Aaint-Lambert 141
Slovenian: Rue Aaint-Lambert 141 B-1200 Bruxelles Belgium
English: Social Anxiety Disorder / Social Phobia
Slovenian: Motnja socialne anksioznosti / socialna fobija
English: Therefore the CHMP recommended that section 4.2 (Posology and Method of Administration) of the SPC should be amended accordingly.
Slovenian: Zato so v CHMP priporočili ustrezno dopolnilo poglavja 4.2 (Odmerjanje in način uporabe) SPC-ja.
English: Conditions of the Marketing Authorisations
Slovenian: Pogoji dovoljenj za promet z zdravilom
English: From the data provided by the MAHs the CHMP concluded that efficacy has not been demonstrated in children and adolescents with major depressive disorder as included in the trials.
Slovenian: Iz podatkov, ki so jih posredovali MAHs, so v CHMP zaključili, da učinkovitost pri otrocih in mladostnikih z veliko depresivno motnjo, ki so bili vključeni v preskušanja, ni bila dokazana.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS Note: This Summary of Product Characteristics (SPC) is the one that was Annexed to the Commission Decision on this Article 31 referral for paroxetine containing medicinal products.
Slovenian: Opomba: Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31, za zdravila, ki vsebujejo paroksetin.
English: From the data provided the CHMP noted that in the fixed dose studies there was a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.
Slovenian: Iz posredovanih podatkov so v CHMP upoštevali, da je bila v študijah s fiksnim odmerkom krivulja odziva na odmerek položna, kar ne kaže na prednost v smislu učinkovitosti pri uporabi odmerkov, višjih od priporočenih.
English: The CHMP also concluded that efficacy has not been demonstrated in children and adolescents with major depressive disorder.
Slovenian: V CHMP so zaključili tudi, da učinkovitost pri otrocih in mladostnikih z veliko depresivno motnjo ni dokazana.
English: In the fixed dose studies there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.
Slovenian: V študijah s fiksnimi odmerki je bila krivulja odziva na odmerek ravna, kar v smislu učinkovitosti ne daje prednosti uporabi višjih odmerkov od priporočenih.
English: Thus paroxetine is eliminated almost entirely by metabolism.
Slovenian: Paroksetin se torej izloča skoraj izključno s presnovo.
English: Considering the above the CHMP concluded that a warning should be included in section 4.4 (Special Warnings and Special Precautions for Use) of the SPC to reflect the risk of development of akathisia in patients treated with paroxetine.
Slovenian: Ob upoštevanju zgoraj navedenega so v CHMP zaključili, da je treba v poglavje 4.4 (Posebna opozorila in previdnostni ukrepi) SPC-ja vključiti opozorilo, ki bo odražalo tveganje za razvoj akatizije pri bolnikih, zdravljenih s paroksetinom.
English: Pregnancy/Neonates
Slovenian: Nosečnost/novorojenčki
English: The long-term efficacy of paroxetine in treating OCD was examined in three 24 week maintenance studies with relapse prevention design.
Slovenian: Dolgoročno učinkovitost paroksetina pri zdravljenju OCD so preiskovali v treh 24-tedenskih vzdrževalnih študijah z zasnovo preprečevanja relapsa.
English: In clinical trials 28% of patients treated with paroxetine reported withdrawal symptoms compared with 19% of placebo treated patients.
Slovenian: V kliničnih preskušanjih so pri 28 % bolnikov, zdravljenih s paroksetinom, poročali o odtegnitvenih simptomih v primerjavi z 19 % pri bolnikih, ki so prejemali placebo.
English: Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations).
Slovenian: V primerjavi s skupino, ki je prejemala placebo so v skupini, ki je prejemala paroksetin pogosteje opazili še naslednje neželene učinke: zmanjšan apetit, tremor, znojenje, hiperkinezijo, agitacijo in čustveno labilnost (vključno z jokom in spreminjanjem razpoloženja).
English: Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or in those with hepatic impairment.
Slovenian: Pri bolnikih s hudo ledvično okvaro (kreatininski očistek manjši od 30 ml/min) ali bolnikih z jetrno okvaro se pojavijo zvišane plazemske koncentracije paroksetina.
English: Medochemie Ltd, 1-10 Constantinoupoleos str. P.O.
Slovenian: Medochemie Ltd, 1-10 Constantinoupoleos str. P.O. Box 51407
English: Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism.
Slovenian: Po peroralnem vnosu se paroksetin dobro absorbira in je izpostavljen metabolizmu prvega prehoda.
English: The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.
Slovenian: Na presnovo in farmakokinetične lastnosti paroksetina lahko vplivata indukcija oziroma inhibicija encimov, ki zdravilo presnavljajo.
English: GlaxoSmithKline BV, Huister Heideweg 62, P.O.Box 780, 3700 At Zeist
Slovenian: Nizozemska GlaxoSmithKline BV, Huister Heideweg 62, P.O.Box 780, 3700 At Zeist
English: In view of these findings the CHMP considered that a statement advising that paroxetine should not be used in children and adolescents should be included in section 4.4 (Special Warnings and Special Precautions for Use) of the SPC and that information on the adverse events from paediatric clinical trials should be included in section 4.8 (Undesirable Effects) of the SPC.
Slovenian: Glede na te najdbe so v CHMP menili, da je treba v poglavje 4.4 (Posebna opozorila in previdnostni ukrepi) SPC-ja vključiti izjavo, ki odsvetuje uporabo paroksetina pri otrocih in mladostnikih, ter da je treba v poglavje 4.8 (Neželeni učinki) SPC-ja vključiti podatke o neželenih učinkih iz pediatričnih kliničnih preskušanj.
English: When paroxetine is to be co-administered with a known drug metabolising enzyme inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.
Slovenian: Pri sočasni uporabi paroksetina in znanega zaviralca encima, ki presnavlja zdravilo je potrebno razmisliti o uporabi odmerkov na spodnji meji odmernega intervala.
English: Transfer to human breast milk, and to the foetuses of laboratory animals, occurs in small amounts.
Slovenian: V materino mleko in fetuse laboratorijskih živali prehaja le majhna količina paroksetina.
English: Rua Alfredo da Silva, 3 - C, P1300-040 Lisboa Portugal
Slovenian: Rua Alfredo da Silva, 3 - C, P1300-040 Lisboa
English: It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).
Slovenian: V primeru, ko zdravljenje s paroksetinom ni več potrebno tako svetujemo postopno prekinitev zdravljenja z zmanjševanjem odmerka (glejte poglavje 4.2 Odmerjanje in način uporabe in poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Therefore, the CHMP concluded that the previous agreed statement advising that paroxetine should not be used in children and adolescents included in section 4.4 (Special Warnings and Special Precautions for Use) of the SPC and the warning in relation to young adults should remain unchanged.
Slovenian: Iz tega razloga je CHMP sklenil, da morata tako predhodno dogovorjena navedba, vključena v poglavje 4.4 (Posebna opozorila in previdnostni ukrepi) SPC, ki odsvetuje uporabo paroksetina pri otrocih in mladostnikih, kakor tudi opozorilo glede uporabe pri mladih odraslih, ostati nespremenjena.
English: General disorder and administration site conditions Common: asthenia, body weight gain Very rare: peripheral oedema.
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti: astenija, pridobivanje telesne teže Zelo redki: periferni edem
English: The long-term efficacy of paroxetine in treating obsessive compulsive disorder has been examined in three 24 week maintenance studies with relapse prevention design.
Slovenian: Dolgoročna učinkovitost paroksetina pri zdravljenju obsesivno-kompulzivne motnje je bila raziskovana v treh 24-tedenskih vzdrževalnih študijah, ki so bile zasnovane tako, da so preprečevale relapse.
English: Rare: hyponatraemia.
Slovenian: Redki: hiponatriemija
English: Richter Gedeon Rt. Gyömrői út 19-21.
Slovenian: Madžarska Richter Gedeon Rt. Gyömrői út 19-21.
English: • Special Warnings and Special Precautions for Use Inclusion/reinforcement of warnings concerning the lack of efficacy and increased risk of suicidal and hostility related behaviours in children and adolescents (7-17), suicide/suicidal ideation and withdrawal symptoms.
Slovenian: Vključitev in poudarek opozoril o pomanjkanju učinkovitosti in povečanem tveganju za s samomorilnostjo in sovražnostjo povezana vedenja pri otrocih in mladostnikih (7-17), samomor/samomorilne ideje ter odtegnitvenih simptomih.
English: Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility.
Slovenian: • Otroci in mladostniki (stari od 7 do 17 let) Paroksetin se ne sme uporabljati za zdravljenje otrok in mladostnikov, saj je bilo z nadzorovanimi kliničnimi raziskavami ugotovljeno, da je paroksetin povezan z večjim tveganjem za samomorilno vedenje in sovražnost.
English: Post-traumatic Stress Disorder
Slovenian: POSTTRAVMATSKA STRESNA MOTNJA
English: POST-TRAUMATIC STRESS DISORDER
Slovenian: Posttravmatska stresna motnja
English: Abrupt discontinuation should be avoided during pregnancy (see "Withdrawal Symptoms Seen on Discontinuation of Paroxetine", section 4.2 Posology and Method of Administration).
Slovenian: Nenadni prekinitvi zdravljenja med nosečnostjo se je potrebno izogibati (glejte "Odtegnitveni simptomi opaženi po prekinitvi zdravljenja s paroksetinom", poglavje 4.2 Odmerjanje in način uporabe).
English: Merck Generics BV, Dieselweg 25, NL-3752 Lb Bunschoten, The Netherlands
Slovenian: NL-3752 Lb Bunschoten, The Netherlands
English: As with other SSRIs, co-administration with serotonergic drugs (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, lithium and St. John's Wort - Hypericum perforatumpreparations) may lead to an incidence of 5-HT associated effects (serotonin syndrome: see Section 4.3 Contraindications and Section 4.4 Special Warnings and Special Precautions for Use).
Slovenian: Tako kot velja za druge selektivne zaviralce prevzema serotonina lahko sočasno dajanje serotoninergičnih zdravil (vključujoč zaviralce monoaminooksidaz, L-triptofan, triptane, tramadol, linezolid, selektivne zaviralce prevzema serotonina, litij in pripravke s šentjanževko - Hypericum perforatum) privede do pojava s serotoninom povezanih učinkov (serotoninski sindrom: glejte poglavje 4.3 Kontraindikacije in poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: Overall data from clinical trials indicate an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old).
Slovenian: Skupni podatki kliničnih preskušanj kažejo, da je tveganje za samomorilno in sovražno vedenje v pediatrični populaciji (7-17 let stari) povečano.
English: There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs.
Slovenian: Pri uporabi selektivnih zaviralcev prevzema serotonina so poročali o kožnih krvavitvah kot so ekhimoze in purpura.
English: In clinical trials increased suicidal related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in children and adolescents treated with paroxetine compared to those treated with placebo.
Slovenian: V kliničnih raziskavah so pri otrocih in mladostnikih, ki so se zdravili s paroksetinom pogosteje opažali samomorilno vedenje (samomorilni poskusi in samomorilne misli) in sovražnost (predvsem agresijo, uporniško obnašanje in jezo) kot pa pri zdravljenju s placebom.
English: Increased plasma concentrations of paroxetine occur in elderly subjects and in those subjects with severe renal impairment or in those with hepatic impairment, but the range of plasma concentrations overlaps that of healthy adult subjects.
Slovenian: Pri starejših osebah in osebah s hudo ledvično ali jetrno okvaro prihaja do večjih koncentracij paroksetina v plazmi, vendar pa je obseg koncentracij v plazmi še vedno v skladu z obsegom pri zdravih odraslih osebah.
English: It is therefore advised that paroxetine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see "Withdrawal Symptoms Seen on Discontinuation of Paroxetine", Section 4.2 Posology and Method of Administration).
Slovenian: Glede na bolnikove potrebe je tako priporočljivo, da se več tednov ali mesecev pred prekinitvijo zdravljenja odmerek postopno zmanjšuje (glejte "Odtegnitveni simptomi opaženi po prekinitvi zdravljenja s paroksetinom", poglavje 4.2 Odmerjanje in način uporabe).
English: The drug should be discontinued in any patient who develops seizures.
Slovenian: Zdravilo je potrebno ukiniti pri bolnikih pri katerih se pojavijo epileptični napadi.
English: Valda Laboratori Farmaceutici S.p.A. - Via Zambeletti, 20021 Baranzate Di Bollate, Milano Italy
Slovenian: - Via Zambeletti, 20021 Baranzate Di Bollate, Milano Italy
English: Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient's response up to the recommended dose.
Slovenian: Bolniki morajo zdravljenje pričeti z odmerkom 10 mg/dan, odmerek pa v skladu z bolnikovim odzivom postopno povečujemo za 10 mg do priporočenega odmerka.
English: Concomitant administration does not seem to show any effect on pharmacokinetic/dynamic profile in epileptic patients.
Slovenian: Pri bolnikih z epilepsijo sočasno dajanje kot kaže ne vpliva na farmakokinetični oziroma farmakodinamični profil.
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Slovenian: Za zagotovilo, da so bolniki z depresijo brez simptomov jih je potrebno zdraviti dovolj dolgo, vsaj 6 mesecev.
English: Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs).
Slovenian: Paroksetin je kontraindiciran v kombinaciji z zaviralci monoaminooksidaz.
English: Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure).
Slovenian: Zelo redki: jetrni primeri (kot so hepatitis, včasih povezan z zlatenico in/ali odpovedjo jeter) Poročali so o zvišanih vrednostih jetrnih encimov.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Slovenian: Torej je med zdravljenjem bolnikov z drugimi psihiatričnimi motnjami potrebno skrbeti za iste previdnostne ukrepe kot med zdravljenjem bolnikov s hudo depresivno motnjo.
English: Based on data from clinical trials and from post marketing there is a possibility of an increased risk of suicidal related behaviour associated with paroxetine in young adults (18-29 years).
Slovenian: Na podlagi podatkov iz kliničnih preskušanj in poročil po uvedbi zdravila na trg obstaja možnost za povečano tveganje za s samomorilnostjo povezanim vedenjem v zvezi s paroksetinom pri mladih odraslih (18-29 let).
English: Paroxetine produces no clinically significant changes in blood pressure, heart rate and ECG after administration to healthy subjects.
Slovenian: Po dajanju zdravim osebam paroksetin klinično pomembno ne vpliva na krvni tlak, srčni utrip in EKG.
English: NSAIDs and acetylsalicylic acid, and other antiplatelet agents A pharmacodynamic interaction between paroxetine and NSAIDs/acetylsalicylic acid may occur.
Slovenian: Nesteroidna protivnetna zdravila, acetilsalicilna kislina in druga antiagregacijska zdravila Med paroksetinom in nesteroidnimi protivnetnimi zdravili/acetilsalicilno kislino lahko pride do farmakodinamične reakcije.
English: For adults, all three studies showed no significant difference in risk for suicidal behaviours among patients receiving different antidepressants or antidepressants of different classes (i.e. Tricyclic antidepressants - TCA - vs. SSRI vs. other antidepressants).
Slovenian: Pri odraslih bolnikih so vse tri študije pokazale, da ni pomembnih razlik v tveganju za samomorilno vedenje med bolniki, ki prejemajo različne antidepresive ali antidepresive iz različnih skupin (npr.
English: OBSESSIVE COMPULSIVE DISORDER
Slovenian: Obsesivno kompulzivna motnja
English: AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 89143 Blaubeuren Germany
Slovenian: Dr. Georg-Spohn-Str. 7 89143 Blaubeuren Germany
English: The indications for which paroxetine is currently approved in EU includemajor depressive disorder (MDD), panic disorder, obsessive compulsive disorder (OCD), social phobia/social anxiety disorder (SAD), generalised anxiety disorder (GAD) and post-traumatic stress disorder (PTSD).
Slovenian: Indikacije, za katere je paroksetin trenutno odobren v EU, vključujejo veliko depresivno motnjo (major depressive disorder, MDD), panično motnjo, obsesivno kompulzivno motnjo (obsessive compulsive disorder, OCD), socialno fobijo/socialno anksiozno motnjo (social anxiety disorder, SAD), generalizirano anksiozno motnjo (generalised anxiety disorder, GAD) in posttravmatsko stresno motnjo (post-traumatic stress disorder, PTSD).
English: Other withdrawal reactions that have been reported on discontinuation of paroxetine include agitation, nausea, tremor, confusion, sweating, diarrhoea, palpitations, emotional instability, irritability and visual disturbances.
Slovenian: Druge odtegnitvene reakcije, o katerih so poročali ob ukinitvi paroksetina, vključujejo agitacijo, slabost, tresenje, zmedenost, znojenje, diarejo, palpitacije, čustveno nestabilnost, razdražljivost in motnje vida.
English: Serotonergic drugs
Slovenian: Serotoninergična zdravila
English: Mixture
Slovenian: Mešanica
English: Ratiopharm Hungary Kft. Uzsoki u. 36/A 1145 Bp
Slovenian: Madžarska Ratiopharm Hungary Kft. Uzsoki u. 36/A
English: Withdrawal symptoms seen on discontinuation of paroxetine treatment
Slovenian: ODTEGNITVENI SIMPTOMI OPAŽENI PO PREKINITVI ZDRAVLJENJA S PAROKSETINOM
English: WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE TREATMENT
Slovenian: Odtegnitveni simptomi opaženi po prekinitvi zdravljenja s paroksetinom
English: A discussion on the efficacy of paroxetine containing medicinal products took place in CHMP based on the Rapporteur´s and Co-Rapporteur´s Assessment Reports and the data presented by the Marketing Authorisation Holders (MAHs).
Slovenian: V CHMP so na podlagi poročil o oceni zdravila (Rapporteur´s in Co-Rapporteur´s Assessment Reports) in podatkov, ki so jih predstavili imetniki dovoljenj za promet z zdravilom (Marketing Authorisation Holders, MAHs), razpravljali o učinkovitosti zdravil, vsebujočih paroksetin.