FrancophonIA/ELRC3.0 huggingface dataset:
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing etoricoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, recommended follow up measures to further investigate the safety of etoricoxib.
Slovenian: Ob upoštevanju, da je CHMP - mnenja, da razmerje med koristjo in tveganjem za zdravila, ki vsebujejo etorikoksib, za dogovorjene indikacije ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženimi mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natančno spremljati in vrednotiti, - in priporočil nadaljnje ukrepe z namenom dodatnega raziskovanja varnosti etorikoksiba.
English: Approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Slovenian: Približno 3100 bolnikov so zdravili z etorikoksibom ≥ 60 mg dnevno 12 tednov ali več.
English: In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
Slovenian: V raziskavah, ki so jih zasnovali posebej za določitev nastopa delovanja etorikoksiba, je delovanje nastopilo že 24 minut po odmerjanju.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redkimi dednimi težavami intolerance za galaktozo, laponskim pomanjkanjem laktaze ali malabsorpcijo glukoze-galaktoze zdravila ne smejo jemati.
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Slovenian: Spol: farmakokinetika etorikoksiba je pri moških in ženskah podobna.
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Slovenian: Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi: - Dodano je opozorilo k poročilu, da se kožne reakcije v večini primerov pojavijo v prvem mesecu zdravljenja.
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thromboembolic events in women at risk).
Slovenian: Povečana izpostavitev EE lahko poveča pojavnost neželenih učinkov, povezanih s peroralnimi kontraceptivi (npr. venske tromboembolije pri ženskah s tveganjem).
English: Aluminum/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Slovenian: Aluminij/aluminij pretisni omoti (enoodemrni) v škatlah po 50 ali 100 tablet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet/tablet contains 60, 90 or 120 mg of etoricoxib.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 60 mg, 90 mg ali 120 mg etorikoksiba.
English: COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Slovenian: Zaviralci COX-2 zmanjšajo tvorbo sistemskega (in zato možno tudi endotelijskega) prostaciklina, ne da bi vplivali na tromboksan.
English: A higher rate of discontinuation due to hypertension was seen (2.3% versus 0.7%) and this was statistically significant.
Slovenian: Opazili so večji delež prekinitev zaradi hipertenzije (2,3 % proti 0,7 %), ki je bil tudi statistično značilen.
English: - Addition of a statement that prescribers should use the lowest effective dose, for the shortest possible duration, and that the need for pain relief should be re-evaluated frequently.
Slovenian: - Dodana je izjava, da naj bo trajanje zdravljenja čim krajše, dnevni odmerek pa najmanjši, ki je še učinkovit, potrebo za lajšanje bolečin pa je potrebno občasno ponovno oceniti.
English: No studies on the effect of etoricoxib on the ability to drive or use machines have been performed.
Slovenian: Raziskave o vplivu etorikoksiba na sposobnost vožnje ali upravljanja s stroji niso bile izvedene.
English: Five metabolites have been identified in man.
Slovenian: Pri človeku so ugotovili pet presnovkov.
English: Estimated renal creatinine clearance <30 mL/min.
Slovenian: Kreatininski očistek ocenjen < 30 ml/min.
English: Paediatric use: Etoricoxib is contra-indicated in children and adolescents under 16 years of age.
Slovenian: Pediatrični bolniki: Etorikoksib je kontraindiciran pri otrocih in mladostnikih, mlajših od 16 let.
English: In clinical trials, etoricoxib was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).
Slovenian: V kliničnih raziskavah so varnost etorikoksiba ovrednotili pri približno 4800 posameznikih, vključno s približno 3400 bolniki z OA, RA ali kronično bolečino v križu (približno 600 bolnikov z OA ali RA se je zdravilo eno leto ali več).
English: Inflammatory bowel disease.
Slovenian: Vnetna bolezen črevesa.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Slovenian: COX-2 ima vlogo tudi pri ovulaciji, vgnezdenju zarodka in zaprtju arterioznega duktusa, regulaciji ledvične funfcije ter funkcije v centralnem živčnem sistemu (indukcija vročine, dojemanje bolečine in kognitivna funkcija).
English: In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Slovenian: V 53- in 106-tedenskih raziskavah toksičnosti so razjede v prebavilih opazili tudi pri izpostavitvah, ki so bile primerljive s tistimi pri človeku pri terapevtskem odmerku.
English: Hepatocellular and thyroid follicular cell adenomas observed in rats are considered to be a consequence of rat-specific mechanism related to hepatic CYP enzyme induction.
Slovenian: Hepatocelularni adenomi in folikularni adenomi ščitnice, ki so jih opazili pri podganah, so posledica za podgane specifičnega mehanizma, povezanega z jetrno indukcijo encimov CYP.
English: The effect of the recommended chronic doses of etoricoxib (60 and 90 mg) has not been studied.
Slovenian: Učinka priporočenih odmerkov etorikoksiba za dolgotrajno zdravljenje (60 in 90 mg) niso preučili.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered.
Slovenian: Če se med zdravljenjem poslabša delovanje kateregakoli organskega sistema opisanega zgoraj, je treba uvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja z etorikoksibom.
English: Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses.
Slovenian: Etorikoksib je lahko povezan s pogostejšo in hujšo hipertenzijo kot nekateri drugi NSAR-i in selektivni zaviralci COX-2, še posebej v velikih odmerkih.
English: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Slovenian: Na podlagi raziskav in vitro ne pričakujemo, da bi etorikoksib zaviral citokrome P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 ali 3A4.
English: As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Slovenian: Ker se tveganje za srčno-žilna obolenja pri večjih odmerkih etorikoksiba in daljši izpostavljenosti zdravilu lahko poveča, naj bo trajanje zdravljenja čim krajše, dnevni odmerek pa najmanjši, ki je še učinkovit.
English: Ketoconazole: Ketoconazole, a potent inhibitor of CYP3A4, dosed at 400 mg once a day for 11 days to healthy volunteers, did not have any clinically important effect on the single-dose pharmacokinetics of 60 mg etoricoxib (43% increase in AUC).
Slovenian: Ketokonazol: Ketokonazol, močan zaviralec CYP3A4, ki so ga v odmerku 400 mg enkrat na dan 11 dni jemali zdravi prostovoljci, ni imel nobenega klinično pomembnega učinka na farmakokinetiko enkratnega 60 mg odmerka etorikoksiba (43 % povečanje AUC).
English: Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis.
Slovenian: Največje tveganje za tak odziv imajo bolniki z že obstoječo pomembno okvaro ledvične funkcije, dekompenziranim srčnim popuščanjem ali cirozo.
English: Uncommon: proteinuria.
Slovenian: Občasne: proteinurija.
English: The majority of elevations in liver function tests on diclofenac that resulted in discontinuation were greater than 3 times the upper limit of normal.
Slovenian: Večina povišanj vrednosti testov jetrne funkcije, ki so privedle do prekinitve zdravljenja, je bilo več kot 3-kratna zgornja meja normale vrednosti.
English: - Strengthening of a warning to highlight that fatal serious skin reactions have now occurred with Cox-2 inhibitors.
Slovenian: - Okrepljeno je opozorilo, ki poudarja, da so se pri uporabi zaviralcev COX-2 pojavile usodno hude kožne reakcije.
English: Further to the assessment of the data on serious skin reactions, etoricoxib is associated with a relatively low rate of serious skin reactions.
Slovenian: Po vrednotenju podatkov o hudih kožnih reakcijah etorikoksib kaže relativno nizko stopnjo pojavnosti takšnih reakcij.
English: Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Slovenian: Diuretik, zaviralci ACE in zaviralci receptorjev angiotenzina: NSAR-i lahko zmanjšajo učinek diuretikov in drugih antihipertenzivnih zdravil.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
Slovenian: Če se pri teh bolnikih pojavijo klinični znaki poslabšanja, je treba ustrezno ukrepati, vključno s prenehanjem zdravljenja z etorikoksibom.
English: While knowledge about effects of multiple sulfotransferases is presently limited and the clinical consequences for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e.g., oral salbutamol and minoxidil).
Slovenian: Ker je znanje o učinkih različnih sulfotransferaz še omejeno in ker klinične posledice velikega števila zdravil še preučujejo, je umestna previdnost pri sočasni uporabi etorikoksiba in drugih zdravil, ki jih primarno presnavljajo človeške sulfotransferaze (npr. peroralni salbutamol in minoksidil).
English: The dose for acute gout should not exceed 120mg daily, limited to a maximum of 8 days treatment.
Slovenian: Odmerek za akutni urični artritis ne sme preseči 120 mg na dan in mora biti omejen na največ 8 dni zdravljenja.
English: In rabbits, no treatment-related external or skeletal foetal malformations were seen.
Slovenian: Pri kuncih niso opazili nobenih z zdravljenjem povezanih zunanjih ali skeletnih malformacij ploda.
English: Fluid retention, oedema and hypertension
Slovenian: Zadrževanje tekočine, edemi in hipertenzija
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance (see section 4.8).
Slovenian: O hudih reakcijah na koži, tudi s smrtnim izidom, vključno z eksfoliativnim dermatitisom, StevensJohnson-ovim sindromom in toksično epidermalno nekrolizo, so med postmarketinškimi raziskavami poročali zelo redko v povezavi z uporabo NSAR-ov in nekaterih selektivnih zaviralcev COX-2 (glejte 4.8).
English: If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
Slovenian: Če se pojavijo znaki jetrne okvare ali če trajno merimo nenormalne vrednosti jetrnih testov (trikratna zgornja meja normalne vrednosti), moramo zdravljenje z etorikoksibom ukiniti.
English: Etoricoxib was not carcinogenic in mice.
Slovenian: Etorikoksib ni deloval karcinogeno pri miših.
English: In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity.
Slovenian: V kliničnih raziskavah enkratni odmerki etorikoksiba do 500 mg in večkratni odmerki do 150 mg dnevno 21 dni niso imeli pomembnih toksičnih učinkov.
English: 4.2 Posology and method of administration <INVENTED NAME> is administered orally and may be taken with or without food.
Slovenian: < IZMIŠLJENO IME > je za peroralno uporabo in se lahko jemlje s hrano ali brez nje.
English: In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.
Slovenian: V kliničnih raziskavah je bil profil neželenih učinkov podoben pri bolnikih z OA ali RA, ki so jih z etorikoksibom zdravili leto dni ali več.
English: A prespecified, combined analysis of eight clinical trials of approximately 4000 patients with OA, RA, or chronic low back pain assessed the incidence rate for the following endpoints: 1) discontinuation for upper GI symptoms; 2) discontinuation for any GI adverse experiences; 3) new use of gastroprotective medications; and 4) new use of any GI medications.
Slovenian: V vnaprej opredeljeni, kombinirani analizi osmih kliničnih raziskav, ki je zajela približno 4000 bolnikov z OA, RA ali kronično bolečino v križu, so ocenjevali pojavnost naslednjih opazovanih dogodkov: 1) prekinitev zdravljenja zaradi simptomov v zgornjih prebavilih, 2) prekinitev zdravljenja zaradi kakršnihkoli prebavnih neželenih učinkov, 3) uvedba zdravljenja z gastroprotektivnimi pripravki in 4) uvedba zdravljenja s katerimkoli zdravilom za zdravljenje bolezni prebavil.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Slovenian: Razmisliti je treba o spremljanju ledvične funkcije po začetku kombiniranega zdravljenja in periodično potem.
English: Follow-up measures of the Marketing Authorisation Holder As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below: Area
Slovenian: Nadaljnji ukrepi imetnika dovoljenja za promet z zdravilom Glede na zahteve CHMP-ja se je imetnik dovoljenja za promet strinjal, da bo izvedel nadaljnje ukrepe kot so navedeni spodaj
English: - Addition of a warning for patients with a history of any drug allergy.
Slovenian: - Dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo.
English: all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Slovenian: vsi dostopni podatki kažejo povečano tveganje neželenih kardiovaskularnih reakcij pri skupini zaviralcev Cox-2 in soglašal, da obstaja povezava med trajanjem jemanja in odmerki ter verjetnostjo pojava kardiovaskularne reakcije.
English: In preclinical studies, etoricoxib has been demonstrated not to be genotoxic.
Slovenian: V predkliničnih raziskavah se je pokazalo, da etorikoksib ni genotoksičen.
English: Caution should be exercised when co-administering etoricoxib with warfarin or other oral anticoagulants (see section 4.5).
Slovenian: Previdnost je potrebna pri sočasni uporabi etorikoksiba z varfarinom ali drugimi peroralnimi antikoagulanti (glejte 4.5).
English: COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 predstavlja izoobliko encima, za katero se je pokazalo, da jo inducirajo provnetni dražljaji in za katerega domnevajo, da je odgovoren predvsem za sintezo prostanoidnih mediatorjev bolečine, vnetja in vročine.
English: The use of etoricoxib in patients with creatinine clearance <30 ml/min is contraindicated (see sections 4.3 and 4.4).
Slovenian: Uporaba etorikoksiba pri bolnikih s kreatininskim očistkom < 30 ml /min je kontraindicirana (glejte 4.3 in 4.4).
English: Cyclosporin and tacrolimus: Although this interaction has not been studied with etoricoxib, coadministration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus.
Slovenian: Ciklosporin in takrolimus: Čeprav te interakcije z etorikoksibom niso preučevali, lahko sočasna uporaba ciklosporina ali takrolimusa in kateregakoli NSAR-a poveča nefrotoksični učinek ciklosporina ali takrolimusa.
English: SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Slovenian: ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: It is not known whether etoricoxib is excreted in human milk.
Slovenian: Ni znano, ali se etorikoksib izloča v materino mleko.
English: Therefore antiplatelet therapies should not be discontinued (see sections 4.5 and 5.1).
Slovenian: Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte zgoraj in poglavji 4.5 in 5.1).
English: These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.
Slovenian: Ta povečanja koncentracije estrogena je treba upoštevati pri izboru pomenopavzalnega hormonskega zdravljenja pri bolnicah, ki jemljejo etorikoksib, saj večja izpostavljenost estrogenu poveča tveganje neželenih učinkov, povezanih s hormonskim nadomestnim zdravljenjem.
English: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen,
Slovenian: - novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom; - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA) and the pain and signs of inflammation associated with acute gouty arthritis.
Slovenian: Simptomatsko lajšanje bolečine pri zdravljenju osteoartroze (OA), revmatoidnega artritisa (RA) ter bolečine in znakov vnetja, povezanih z akutnim uričnim artritisom.
English: To continue to monitor patient exposure to etoricoxib in GPRD and evaluate potential contribution of observational study(-ies).
Slovenian: Da bo v GPRD (General Practice Research Database) še naprej spremljal izpostavljenost bolnikov etorikoksibu ter ocenil možen prispevek opazovalne/ih študije/ij.
English: Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Slovenian: Po enkratnem intravenskem odmerku 25 mg radioaktivno označenega etorikoksiba, ki so ga dobili zdravi preiskovanci, se je 70 % radioaktivnosti izločilo v urinu in 20 % v blatu, večinoma v obliki presnovkov.
English: - Addition of a warning for prescribers relating to hypertension and monitoring blood pressure during treatment with etoricoxib.
Slovenian: - Dodano je opozorilo v zvezi s hipertenzijo in spremljanjem krvnega tlaka med zdravljenjem z etorikoksibom.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed (see section 4.4).
Slovenian: Zato je potrebno pri bolnikih, ki prejemajo peroralne antikoagulante, skrbno spremljati protrombinski čas, izražen z INR, še posebej prvih nekaj dni po začetku zdravljenja ali po spremembi odmerka etorikoksiba (glejte 4.4).
English: The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome; hepatotoxicity including hepatic failure, jaundice and pancreatitis.
Slovenian: V povezavi z NSAR-i so poročali o naslednjih resnih neželenih učinkih, ki jih pri etorikoksibu ne moremo izključiti: nefrotoksičnost, vključno z intersticijskim nefritisom in nefrotskim sindromom; hepatotoksičnost, vključno z jetrno odpovedjo, zlatenico in pankreatitisom.
English: It may also play a role in ulcer healing.
Slovenian: Lahko igra vlogo tudi pri celjenju razjed.
English: There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).
Slovenian: Kliničnih izkušenj pri bolnikih s hudo motnjo delovanja jeter (lestvica po Child-Pughu ≥ 10) nimamo, zato je pri teh bolnikih uporaba kontraindicirana (glejte 4.3, 4.4 in 5.2).
English: Dosing with food (a high-fat meal) had no effect on the extent of absorption of etoricoxib after administration of a 120-mg dose.
Slovenian: Jemanje s hrano (obrok z veliko maščobami) ni vplivalo na obseg absorbcije etorikoksiba po zaužitju 120 mg odmerka.
English: However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Slovenian: Vendar pa je treba to spremljati pri bolnikih z velikim tveganjem za toksične učinke digoksina, če se sočasno zdravijo z etorikoksibom in digoksinom.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for etoricoxib containing medicinal products.
Slovenian: Opomba: Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s členom 31, za zdravila, ki vsebujejo etorikoksib.