FrancophonIA/ELRC3.0 huggingface dataset:
English: Candesartan cilexetil is an angiotensin receptor blocker (ARB).
Slovenian: Kandesartan cileksetil je zaviralec angiotenzinskega receptorja (ARB).
English: The approved mutual recognition wording stated “Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.” There were some differences in Member States (MSs') summary of product characteristics' (SPCs) in the approved indication: most countries stated ‘Essential hypertension', one mentioned the word ‘arterial' (which was omitted in the final proposal), and one included the word ‘adult' (which was considered in the final proposal).
Slovenian: Odobreno besedilo iz postopka z medsebojnim priznavanjem je „Esencialna hipertenzija, ko samostojno zdravljenje s kandesartan cileksetilom ali hidroklorotiazidom ni zadostno.“ Med povzetki glavnih značilnosti zdravila v državah članicah je bilo nekaj razlik v odobreni indikaciji: v večini držav je navedena „Esencialna hipertenzija“, v eni je omenjena „arterijska“ (kar je bilo izbrisano iz končnega predloga), v še eni pa je bila vključena beseda „odrasli“ (kar je bilo obravnavano v končnem predlogu).
English: Section 5.1 Pharmacodynamic Properties
Slovenian: Poglavje 5.1 Farmakodinamične lastnosti
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: In line with the SPC Guideline (2009), two MSs included “Treatment of” followed by the indication.
Slovenian: V skladu s smernico za povzetek glavnih značilnosti zdravila (2009) je bilo v dveh državah članicah navedeno besedilo „Zdravljenje“, čemur je sledila indikacija.
English: This section was shortened and harmonised taking into account the current scientific knowledge and in line with the discussions for other sections of the SPC.
Slovenian: To poglavje je bilo skrajšano in usklajeno z upoštevanjem trenutnega znanstvenega vedenja ter razprave v zvezi z drugimi poglavji povzetka glavnih značilnosti zdravila.
English: In particular, regarding interactions with potassium sparing diuretics, or other medicinal products that may increase serum potassium levels, other medicinal products that induce torsades de pointes, NSAIDS, colestipol or cholestyramine, nondepolarising skeletal muscle relaxants, calcium supplements or vitamin D, betablockers and diazoxide, anticholinergic agents, amantadine, cytotoxic medicinal products, alcohol intake, barbiturates, anaesthetics, antidiabetic medicinal products, pressor amines, iodinated contrast media and cyclosporine, among others.
Slovenian: Zlasti v zvezi z interakcijami z diuretiki, ki varčujejo s kalijem, drugimi zdravili, ki morda zvišajo serumske ravni kalija, drugimi zdravili, ki sprožijo torsades de pointes, nesteroidnimi protivnetnimi zdravili, kolestipolom ali holestiraminom, nedepolarizirajočimi relaksansi skeletnih mišic, dopolnili kalcija ali vitamina D, zaviralci beta in diazoksidom, antiholinergičnimi sredstvi, amantadinom, citotoksičnimi zdravili, vnosom alkohola, barbituratov, anestetiki, antidiabetiki, presorskimi amini, jodiranimi kontrastnimi sredstvi in ciklosporinom ter drugim.
English: All countries' SPCs for candesartan/HCT 16/12.5 mg or higher strengths included a recommendation on dose titration of candesartan before switching to the fixed dose combination.
Slovenian: V povzetkih glavnih značilnosti kombinacije kandesartan/HCT 16/12,5 mg ali več je bilo v vseh državah članicah dodano priporočilo o titraciji odmerka kandesartana pred prehodom na kombinacijo s fiksnim odmerkom.
English: In particular, the indication and its associated posology recommendation, the contraindications and the pregnancy and lactation sections were harmonised.
Slovenian: Usklajene so bile zlasti indikacije, z njimi povezana priporočila za odmerjanje, kontraindikacije ter poglavji o nosečnosti in dojenju.
English: Furthermore, hydrochlorothiazide was omitted, as Atacand Plus contains hydrochlorothiazide.
Slovenian: Poleg tega je bil izbrisan hidroklorotiazid, saj zdravilo Atacand Plus vsebuje hidroklorotiazid.
English: The CHMP endorsed this updated information proposed by the MAH as harmonised text: “In controlled clinical studies with candesartan cilexetil/hydrochlorothiazide adverse reactions were mild and transient.
Slovenian: CHMP je potrdil to posodobljeno informacijo, ki jo je predlagal imetnik dovoljenja za promet z zdravilom kot usklajeno besedilo: „V kontroliranih kliničnih študijah s kombinacijo kandesartan cileksetil/hidroklorotiazid so bili neželenih učinki blagi in prehodni.
English: Based on the above, the CHMP considers the benefit risk ratio of Atacand Plus to be favourable and the harmonised PI to be appropriate.
Slovenian: Na osnovi navedenega je CHMP upošteval, da je razmerje med koristmi in tveganji za zdravilo Atacand Plus ugodno in da je usklajeno navodilo za uporabo ustrezno.
English: The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to the active substances or to any of the excipients, severe renal and hepatic impairment and/or cholestasis, refractory hypokalaemia and hypercalcaemia, and gout.
Slovenian: CHMP se je strinjal tudi z vključitvijo kontraindikacije pri bolnikih s preobčutljivostjo na zdravilne učinkovine ali katero koli pomožno snov ter hudo ledvično ali jetrno okvaro in/ali holestazo, refraktarno hipokaliemijo in hiperkalciemijo ter protinom.
English: The CHMP considered that the benefit/risk balance of candesartan cilexetil/hydrochlorothiazide is positive for the below mentioned indication and the proposed wording was supported and in line with current SPC guideline: “Treatment of essential hypertension, in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy”.
Slovenian: CHMP je menil, da je razmerje med koristmi in tveganji za kombinacijo kandesartan cileksetil/hidroklorotiazid pozitivno za spodaj navedeno indikacijo, zato je bilo predlagano besedilo podprto in v skladu s trenutno smernico za povzetek glavnih značilnosti zdravila: „Zdravljenje esencialne hipertenzije pri odraslih bolnikih, ko samostojno zdravljenje s kandesartan cileksetilom ali hidroklorotiazidom ne uravnava krvnega tlaka optimalno.“
English: These subheadings in this section of the SPCs were revised in accordance with the SPC Guideline (2009).
Slovenian: Podnaslovi v tem poglavju povzetka glavnih značilnosti zdravila so bili popravljeni v skladu s smernico za povzetek glavnih značilnosti zdravila (2009).
English: Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended.
Slovenian: Priporoča se titracija odmerka s posameznimi komponentami (kandesartan cileksetil in hidroklorotiazidom).
English: In particular, updates on clinical efficacy in elderly hypertensive patients, where results from a trial in elderly patients were included, the pharmacodynamic effects of HCT, and the clinical efficacy of candesartan/HCT in hypertensive patients were considered.
Slovenian: Predvsem so obravnavali posodobitve o klinični učinkovitosti pri starostnikih s hipertenzijo (saj so bili vključeni rezultati preskušanja pri starostnikih), farmakodinamične učinke hidroklorotiazida in klinična učinkovitost kombinacije kandesartan cileksetil/hidroklorotiazid pri bolnikih s hipertenzijo.
English: The CHMP endorsed the harmonised text finding the proposed wording acceptable and in line with that of other ARB or antihypertensive SPCs.
Slovenian: CHMP je potrdil usklajeno besedilo, saj je bilo predlagano besedilo sprejemljivo in v skladu z besedilom drugih povzetkov glavnih značilnosti zdravil ARB in antihipertenzijskih zdravil.
English: Warnings regarding renal impairment, kidney transplantation pregnancy, renal artery stenosis, intravascular volume depletion, anaesthesia and surgery, hepatic impairment, aortic and mitral valve stenosis, primary hyperaldosteronism, electrolyte imbalance, metabolic and endocrine effects, photosensitivity, pregnancy and others were harmonised.
Slovenian: Usklajena so bila opozorila o okvarjenem delovanju ledvic, presaditvi ledvic v nosečnosti, stenozi ledvične arterije, zmanjšanem intravaskularnem volumnu, anesteziji in kirurškem posegu, okvari delovanja jeter, stenozi aortne in mitralne zaklopke, primarnem hiperaldosteronizmu, neravnovesju elektrolitov, presnovnih in endokrinih učinkih, občutljivosti za svetlobo, nosečnosti in drugem.
English: Atacand Plus contains candesartan cilexetil and hydrochlorothiazide (HCT).
Slovenian: Zdravilo Atacand Plus vsebuje kandesartan cileksetil in hidroklorotiazid (HCT).
English: This section was updated in accordance with the SPC Guideline (2009), including all ADRs listed in most countries, as the harmonised text.
Slovenian: To poglavje je bilo kot usklajeno besedilo posodobljeno v skladu s smernico za povzetek glavnih značilnosti zdravila (2009), vključno z vsemi neželenimi učinki, navedenimi v večini držav.
English: A full contraindication in pregnancy and during lactation was previously included in most SPCs.
Slovenian: V večino povzetkov glavnih značilnosti zdravila je bila že prej vključena kontraindikacija v nosečnosti in v obdobju dojenja.
English: Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Slovenian: Zdravilo Atacand Plus se lahko uporablja pri bolnikih, ko samostojno zdravljenje s kandesartan cileksetilom ali hidroklorotiazidom ali manjšimi odmerki zdravila Atacand Plus ne uravnava krvnega tlaka optimalno.
English: When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered.
Slovenian: Če je klinično primerno, lahko opravite neposreden prehod iz samostojnega zdravljenja na zdravilo Atacand Plus.
English: In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted the harmonised set of PI for Atacand Plus and associated names.
Slovenian: CHMP je na osnovi ocene predlogov in odgovorov imetnika dovoljenja za promet z zdravilom ter po razpravi znotraj Odbora sprejel usklajene komplete navodila za uporabo zdravila Atacand Plus in z njim povezanih imen.
English: Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.
Slovenian: Titracija odmerka kandesartan cileksetila je priporočljiva, če prehajate iz samostojnega zdravljenja s hidroklorotiazidom.
English: The sections on use in the elderly, patients with intravascular volume depletion, patients with renal impairment, patients with hepatic impairment and paediatric population were also harmonised.
Slovenian: Usklajena so bila tudi poglavja o uporabi pri starostnikih, bolnikih z zmanjšanim intravaskularnim volumnom, bolnikih z okvarjenim delovanjem jeter in otrocih.
English: The changes to the SPC were taken into account in the amendments to the PL and labelling as appropriate.
Slovenian: Spremembe povzetka glavnih značilnosti zdravila so bile po potrebi upoštevane pri dopolnitvah navodila za uporabo in označevanja.
English: Cough was added as a very rare ADR to section 4.8 of the SPC, as a result of the PSUR evaluation for candesartan/HCT.
Slovenian: Kot zelo redek neželeni učinek je bil v poglavje 4.8 povzetka glavnih značilnosti zdravila dodan kašelj, zaradi ocene rednega posodobljenega poročila o varnosti zdravila za kombinacijo kandesartan cileksetil/hidroklorotiazid.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Atacand Plus and associated names (see Annex I).
Slovenian: • Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
English: Based on the information provided, the CHMP endorsed the harmonised text for the AIIRA as the standard warning elaborated by the CHMP's PhVWP for all AIIRA: the use of AIIRAs in the first trimester of pregnancy is not recommended; the use of AIIRAs in the second and third trimester is contraindicated.
Slovenian: Na osnovi predloženih informacij je CHMP usklajeno besedilo za AIIRA potrdil kot standardno opozorilo za vse AIIRA.
English: This wording was considered in the proposed harmonised SPC.
Slovenian: Besedilo je bilo obravnavano v predlaganem usklajenem povzetku glavnih značilnosti zdravila.
English: Based on the information available in the MS'sSPC, this section was updated.
Slovenian: To poglavje je bilo posodobljeno na osnovi razpoložljivih informacij v povzetkih glavnih značilnosti zdravila v državah članicah.
English: Adopted at the 11-14 June 2019 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 11. in 14. junijem 2019
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, takoj obvestite svojega zdravnika.
English: What you need to know before you take [Product name] Pregnancy
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Nosečnost
English: Please see Section 4.4 “Interference with laboratory testing”.
Slovenian: Glejte poglavje 4.4 „Vpliv na laboratorijske preiskave“.
English: Possible side effects Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1 000 bolnikov):
English: Results should be interpreted in conjunction with clinical findings
Slovenian: Rezultate je treba interpretirati v povezavi s kliničnimi izsledki.
English: Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis
Slovenian: Redki: eksfoliativni dermatitis 2) 2) O primerih so poročali pri bolnikih z diagnozo psoriaze
English: Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine.
Slovenian: Pri interpretaciji teh laboratorijskih rezultatov pri bolnikih, ki prejemajo sulfasalazin, je potrebna previdnost.
English: You may need treatment with [Product name] during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Slovenian: Morda boste med nosečnostjo potrebovali zdravljenje z zdravilom [ime zdravila], če morebitna korist odtehta morebitno tveganje za vas in vašega nerojenega otroka.
English: Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
Slovenian: Epidemiološke študije dajejo nasprotujoče si rezultate glede tveganja za prirojene malformacije.
English: Interference with laboratory testing
Slovenian: Vpliv na laboratorijske preiskave
English: • redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
Slovenian: • pordelost in luščenje kože na večjem predelu telesa, kar lahko srbi ali boli (eksfoliativni dermatitis)
English: What you need to know before you take sulfasalazine Tell your doctor if you are taking or have recently taken [Product name], or any other sulfasalazine containing products, because they may affect results of blood and urine tests.
Slovenian: Kaj morate vedeti, preden boste vzeli sulfasalazin Obvestite zdravnika, če jemljete ali ste pred kratkim jemali zdravilo [ime zdravila] ali katero koli drugo zdravilo, ki vsebuje sulfasalazin, ker lahko vpliva na rezultate krvnih in urinskih preiskav.
English: Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose.
Slovenian: Primeri tovrstnih testov so preiskave sečnine, amoniaka, LDH, α-HBDH in glukoze.
English: Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.
Slovenian: Ženske v rodni dobi je treba seznaniti z morebitnimi tveganji uporabe propiltiouracila med nosečnostjo.
English: Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome.
Slovenian: Posebna opozorila in previdnostni ukrepi […] Preveliko odmerjanje lahko razkrije obstoječi Brugadov sindrom.
English: Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength.
Slovenian: Sulfasalazin ali njegovi presnovki lahko vplivajo na absorbanco ultravijolične svetlobe, zlasti pri 340 nm, in lahko povzročajo motnje nekaterih laboratorijskih testov, ki za merjenje absorbance ultravijolične svetlobe okoli te valovne dolžine uporabljajo NAD(H) ali NADP(H).
English: Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS)
Slovenian: Pogostnost „neznani“: Reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
English: Fertility, pregnancy and lactation Women of childbearing potential
Slovenian: Plodnost, nosečnost in dojenje
English: The potential of [Product name] to cause harm to an unborn baby is uncertain.
Slovenian: Ni gotovo, ali zdravilo [ime zdravila] lahko škoduje nerojenemu otroku.
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Slovenian: Rivaroksaban se ne sme uporabljati za tromboprofilakso pri bolnikih, ki so pred kratkim prestali transkatetrsko zamenjavo aortne zaklopke (TAVR- transcatheter aortic valve replacement).
English: If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.
Slovenian: Če se propiltiouracil uporablja med nosečnostjo, je priporočeno skrbno spremljanje matere, ploda in novorojenčka.
English: Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379)
Slovenian: Loperamid - Brugadov sindrom v okviru zlorabe loperamida (št. EPITT 19379)
English: Tell your doctor, or seek medical attention immediately if you have the following side effects: Frequency not known (cannot be estimated from the available data): - Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): - vnetje očesa (uveitis) s simptomi, kot so pordelost očesa, bolečina, občutljivost za svetlobo, izcedek iz oči, prikazovanje majhnih pikic ali zamegljen vid
English: Frequency not known: uveitis
Slovenian: Neznana pogostnost: uveitis
English: Consult with the testing laboratory regarding the methodology used.
Slovenian: Glede uporabljene metodologije se posvetujte z laboratorijem, kjer opravljajo preiskave.
English: Animal studies are insufficient with respect to reproductive toxicity.
Slovenian: Študije vpliva na sposobnost razmnoževanja na živalih niso zadostne.
English: Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones.
Slovenian: Propiltiouracil med nosečnostjo je treba dajati v najmanjšem učinkovitem odmerku, brez dodajanja ščitničnih hormonov.
English: Propylthiouracil is able to cross the human placenta.
Slovenian: Propiltiouracil lahko prehaja skozi človeško placento.
English: […] Overdose can unmask existing Brugada syndrome.
Slovenian: Preveliko odmerjanje […] Preveliko odmerjanje lahko razkrije obstoječi Brugadov sindrom.
English: Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332)
Slovenian: Temozolomid - reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)(št. EPITT 19332)
English: Rivaroxaban - Premature ending of the GALILEO study in patients who have received an artificial heart valve through a transcatheter aortic valve replacement (TAVR) (EPITT no
Slovenian: Rivaroksaban - predčasen zaključek študije GALILEO pri bolnikih, ki so prejeli umetno srčno zaklopko s transkatetrsko zamenjavo aortne zaklopke (TAVR) (št. EPITT 19294)
English: It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses.
Slovenian: Možno je, da se med zdravljenjem z velikimi odmerki sulfasalazina motnje pokažejo tudi pri merjenju alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST), kreatin-kinaze v mišicah/možganih (CK-MB), glutamatdehidrogenaze (GLDH) ali tiroksina.
English: Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354)
Slovenian: Sekukinumab - generalizirani eksfoliativni dermatitis (št. EPITT 19354)
English: Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351)
Slovenian: Sulfasalazin - motnje testov z reakcijo dihidronikotinamidadenindinukleotida/dihidronikotinamidade nindinukleotidfosfata (NADH/NADP) (št. EPITT 19351)
English: Topiramate - Uveitis (EPITT no 19345)
Slovenian: Topiramat - uveitis (št. EPITT 19345)
English: Patients with prosthetic valves
Slovenian: Bolniki z umetnimi zaklopkami
English: Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy.
Slovenian: Pred zdravljenjem s propiltiouracilom med nosečnostjo je potrebna individualna ocena razmerja med tveganji in koristmi.
English: Undesirable effects Eye disorders
Slovenian: Preglednica z neželenimi učinki
English: Overdose
Slovenian: Očesne bolezni
English: 3.75 micrograms propagated in eggs ** haemagglutinin
Slovenian: namnožen v jajcih ** hemaglutinin
English: Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection
Slovenian: Suspenzija in emulzija za emulzijo za injiciranje
English: After mixing, 1 dose (0.5 ml) contains: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Slovenian: A/Indonesia/05/2005 (H5N1) podobnemu sevu (PR8-IBCDC-RG2) 3,75 mikrogramov**
English: Strength Pharmaceutical form
Slovenian: KG Arzneimittel
English: Linoladiol EstradiolEmulsion
Slovenian: Linoladiol EstradiolEmulsion vaginalna emulzija Dermalna uporaba,
English: Linoladiol N 0,1 mg/g vaginal cream
Slovenian: Linoladiol N 0,1 mg/g vaginal cream vaginalna krema Vaginalna uporaba,
English: 0.01 % w/w estradiol containing medicinal products for topical use Member
Slovenian: Zdravila za topično uporabo, ki vsebujejo 0,01 % m/m estradiola Država članica (v EGP)
English: 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member
Slovenian: Zdravila za topično uporabo, ki vsebujejo 0,005 % m/m estradiola/0,4 % m/m prednizolona Država članica (v EGP)
English: Further information on Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Tafinlar so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tafinlar is available as capsules (50 and 75 mg).
Slovenian: Zdravilo Tafinlar je na voljo v obliki kapsul (50 in 75 mg).
English: What measures are being taken to ensure the safe and effective use of Tafinlar?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tafinlar?
English: Other information about Tafinlar
Slovenian: Druge informacije o zdravilu Tafinlar
English: Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013.
Slovenian: Za zdravilo Tafinlar je bilo 26. avgusta 2013 izdano dovoljenje za promet, veljavno po vsej EU.