FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: the following may affect up to 1 in 1,000 people - pneumonia - signs include feeling short of breath and producing discoloured phlegm - high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart - blood problems such as unusual blood clotting or prolonged bleeding - severe allergic reactions, including widespread blistering rash and skin peeling - mental problems such as hearing voices or seeing things that are not there - fainting - having problems thinking or talking, having jerking movements, especially in your hands that you cannot control - stroke - signs include pain, weakness, numbness, or tingling in the limbs - having a blind or dark spot in your field of vision - heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death - blood clots in your legs (deep vein thrombosis) - signs include intense pain or swelling of the legs - blood clots in your lungs (pulmonary embolism) - signs include feeling short of breath or pain while breathing
Maltese: uġigħ fl-istonku titfewwaq tħossok nervuż Rari: dawn li ġejjin jistgħu jaffettwaw sa 1 minn kull 1,000 persuna pulmonite - is-sinjali jinkludu qtugħ ta' nifs u produzzjoni ta' mħat imdennes pressjoni għolja tad-demm fil-vini u l-arterji tal-pulmuni (pressjoni għolja pulmonari) din tista' tikkawża ħsara serja fil-pulmun tiegħek u f'qalbek problemi fid-demm bħal tagħqid tad-demm mhux tas-soltu jew fsada fit-tul reazzjonijiet allerġiċi severi, inkluż raxx mifrux bl-infafet u tqaxxir tal-ġilda problemi mentali bħal smigħ ta' vuċijiet jew tara ħwejjeġ li ma jkunux hemm ħass ħażin problemi biex taħseb jew titkellem, movimenti bl-iskossi, speċjalment f'idejk li ma tistax tikkontrollahom puplesija - is-sinjali jinkludu wġigħ, dgħufija, tirżiħ, jew tingiż fid-dirgħajn u r-riġlejn ikollok tikka għamja jew skura fil-kamp viżiv tiegħek insuffiċjenza tal-qalb jew attakk tal-qalb li jistgħu jwasslu għal waqfien tat-taħbit tal-qalb jew mewt, problemi fir-ritmu tal-qalb, b'mewt f'daqqa emboli f'saqajk (trombożi fil-vini fil-fond) - is-sinjali jinkludu wġigħ qawwi jew nefħa fis- saqajn emboli fil-pulmun (emboliżmu pulmonari) - is-sinjali jinkludu qtugħ ta' nifs jew uġigħ waqt it- teħid tan-nifs fsada fl-istonku jew fl-imsaren - is-sinjali jinkludu rimettar tad-demm jew tgħaddi d-demm fl- ippurgar tiegħek sadd fl-imsaren (ostruzzjoni intestinali) speċjalment fl-“ileu”.
English: The AUC of posaconazole is: 4 times greater when administered with a high fat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5).
Maltese: L-AUC ta' posaconazole huwa: 4 darbiet ogħla meta jingħata ma' ikla b'kontenut għoli ta' xaħam (~ 50 gramma xaħam) u madwar 2.6 darbiet ogħla meta jingħata ma' ikla b'kontenut mhux għoli ta' xaħam jew b'suppliment nutrizzjonali (14- gramma xaħam) imqabbel mal-istat sajjem (ara sezzjoni 4.2 u 4.5).
English: Posaconazole AHCL contains glucose
Maltese: Kif jidher Posaconazole AHCL u l-kontenut tal-pakkett
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Vinca alkaloids
Maltese: - Candida albicans:
English: Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Maltese: L-għotja flimkien ma' sustrati ta' CYP3A4 terfenadine, astemizole, cisapride, pimozide, halofantrine jew quinidine peress li dan jista' jwassal għal żieda tal-konċentrazzjonijiet fil-plażma ta' dawn il- prodotti mediċinali, li jwasslu sabiex il-QTc jitwal u jkun hemm każijiet rari ta'
English: Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Maltese: - Pazjenti li qed jirċievu kimoterapija ta' remissjoni-induzzjoni għall-lewkimja majeloġenuża (AML) jew għal sindromi majelodisplastiċi (MDS) li jkunu mistennija li jikkawżaw newtropenja u li jkollhom riskju għoli li jiżviluppaw infezzjonijiet tal-fungu invażivi;
English: Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Maltese: Ħalli l antifungali azole, inkluż posaconazole, għal pazjenti li jirċievu alkalojdi vinka, inkluż vincristine,
English: Clinical isolates with decreased susceptibility to posaconazole have been identified.
Maltese: Reżistenza Iżolati kliniċi li kienu anqas suxxettibli għal posaconazole kienu identifikati.
English: rash, pruritis
Maltese: tnaqqis tas-smigħ
English: Coccidioidomycosis
Maltese: Farmakokinetiċi f'popolazzjonijiet speċjali
English: The filled and sealed bottle is packed into a carton along with a graduated polystyrene spoon (2.5 mL and 5 mL) for dispensing and administration of the suspension.
Maltese: Il-flixkun mimli u ssiġillat huwa ppakkjat f'kartuna flimkien ma' kuċċarina tal-polystyrene ggradwata (2.5 mL u 5 mL) għaddispensjoni u għall-għoti tas-suspensjoni.
English: Posaconazole AHCL can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped; - infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; - infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
Maltese: infezzjonijiet ikkawżati minn fungu tal-familja tal-Aspergillus li ma jkunux tjiebu meta jkunu ġew ikkurati bil-mediċini kontra l-fungu amphotericin B jew itraconazole jew meta dawn ilmediċini kellhom jitwaqqfu; infezzjonijiet ikkawżati minn fungu tal-familja Fusarium li ma jkunux tjiebu meta jkunu ġew ikkurati b'amphotericin B jew meta amphotericin B kellu jitwaqqaf;
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Maltese: Huwa importanti b'mod partikolari li tipprova taċċerta ruħek li jinkisbu l-ogħla livelli filplażma f'pazjenti infettati b'Aspergillus (ara sezzjonijiet 4.2 u 5.2 dwar il-korsijiet tad-dożi rakkomandati u l- effetti tal-ikel fuq l-assorbiment).
English: Cases of elevated ciclosporin levels resulting in serious adverse reactions, including nephrotoxicity and one fatal case of leukoencephalopathy, were reported in clinical efficacy studies.
Maltese: Każijiet ta' żidiet fil-livelli ta' ciclosporin li wasslu għal reazzjonijiet avversi severi, inkluża nefrotossiċità u każ fatali ta' lewko-enċefalopatija, kienu rrappurtati fi studji dwar l-effikaċja klinika.
English: Children Posaconazole AHCL should not be used in children (17 years of age and younger).
Maltese: Posaconazole AHCL m'għandux jintuża fi tfal (ta' 17-il sena u iżgħar).
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Maltese: b: F'1899 dan kien il-perijodu minn meta kienu randomized sa l-aħħar doża tal-prodott mediċinali li qed jiġi studjat u
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Maltese: It-tagħrif mikrobijoloġiku jindika li posaconazole huwa attiv kontra Rhizomucor, Mucor, u Rhizopus; iżda it-tagħrif kliniku għadu limitat wisq sabiex tkun evalwata l-effikaċja ta' posaconazole kontra dawn l-aġenti kawżattivi.
English: LIST OF EXCIPIENTS Contains glucose.
Maltese: Fih glucose.
English: Patients with glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti b'malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: abnormal dreams, confusional state, sleep disorder
Maltese: ħolm stramb, stat konfużjonali, disturb fl-irqad disturb psikotiku, dipressjoni
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Maltese: L-imaniġġar tal- pazjenti għandu jinkludi evalwazzjoni permezz ta' laboratorju talfunzjoni epatika (l-aktar testijiet tal- funzjoni tal-fwied u bilirubin).
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Maltese: Il-valuri ECOFF għal posaconazole, li jiddistingwu l-popolazzjoni li tinstab fin-natura minn iżolati li akkwistaw reżistenza, ġew stabbiliti bil-metodoloġija EUCAST.
English: Due to the risk of prolonged sedation it is recommended that dose adjustments should be considered when posaconazole is administered concomitantly with any benzodiazepine that is metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) (see section 4.4).
Maltese: Minħabba r-riskju li l-pazjent jitraqqad għal żmien twil huwa rakkomandat li jiġi kkunsidrat li ddożi jiġu aġġustati meta posaconazole jingħata fl-istess ħin ma' kwalunkwe benzodiazepin li jiġi metabolizzat minn CYP3A4 (eż. midazolam, triazolam, alprazolam) (ara sezzjoni 4.4).
English: Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis
Maltese: Rata ta' suċċess kliniku kienet definita bħala n-numru ta' każijiet meqjusa li għandhom rispons kliniku (fejqan jew titjib) diviż man-numru totali ta' każijiet eliġibbli għall-analiżi
English: Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Maltese: rifabutin u rifampicin (jintużaw għall-kura ta' ċerti infezzjonijiet).
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Maltese: Rarament, reazzjonijiet epatiċi aktar severi li wasslu għall-mewt kienu rrappurtati.
English: Posaconazole AHCL with food and drink
Maltese: Posaconazole AHCL ma' ikel u xorb
English: The following medicines may decrease the effectiveness of Posaconazole AHCL by decreasing the amount of Posaconazole AHCL in the blood: - rifabutin and rifampicin (used to treat certain infections).
Maltese: Posaconazole AHCL jista' possibilment iżid ir-riskju ta' effetti sekondarji ta' xi mediċini oħrajn billi jżid l-ammont ta' dan il-mediċini fid-demm.
English: In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
Maltese: Fi studju ta' 136 pazjent newtropeniku pedjatriku ta' 11-il xahar - 17-il sena kkurati b'posaconazole suspensjoni orali f'dożi sa 18 mg/kg/ġurnata
English: EU (MA) number
Maltese: Numru tal-UE (AM)
English: Packaging Content Package size
Maltese: Il-Pakkett Kontenut Daqs talpakkett
English: EU Number
Maltese: Numru talproċedura tal-UE
English: Target Species
Maltese: Speċijiet fil-mira
English: Route of Administration
Maltese: Mnejn Jingħata
English: The full EPAR for Insulin lispro Sanofi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Insulin lispro Sanofi jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In one study, in patients with type 1 diabetes, HbA1c reduced by 0.44 and 0.46 percentage points with Insulin lispro Sanofi and Humalog respectively after 26 weeks; in the second study, in patients with type 2 diabetes, the corresponding figures were 0.93 versus 0.88 percentage points.
Maltese: Fi studju wieħed, f'pazjenti bid-dijabete tat-tip 1, HbA1c naqset b'0.44 u 0.46 punt perċentwali b'Insulin lispro Sanofi u b'Humalog rispettivament wara 26 ġimgħa; fit-tieni studju, f'pazjenti biddijabete tat-tip 2, il-figuri korrispondenti kienu 0.93 kontra 0.88 punt perċentwali.
English: The reference medicine for Insulin lispro Sanofi is Humalog 100 U/ml solution.
Maltese: Il-mediċina ta' referenza għal Insulin lispro Sanofi hija Humalog 100 U/ml soluzzjoni.
English: It contains the active substance insulin lispro.
Maltese: Dan fih is-sustanza attiva insulin lispro.
English: Insulin lispro Sanofi is a ‘biosimilar medicine'.
Maltese: Insulin lispro Sanofi huwa ‘mediċina bijosimili'.
English: Laboratory studies comparing Insulin lispro Sanofi with the reference medicine Humalog have shown that the active substance in Insulin lispro Sanofi is highly similar in terms of structure, purity and biological activity to that of Humalog.
Maltese: Studji tal-laboratorju li jqabblu Insulin lispro Sanofi mal-mediċina ta' referenza Humalog urew li ssustanza attiva f'Insulin lispro Sanofi hija simili ħafna f'termini ta' struttura, purità u attività bijoloġika ma' dik ta' Humalog.
English: Two further studies in a total of 1,012 patients compared Insulin lispro Sanofi with Humalog and found them to be similarly effective at reducing blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose levels are controlled over time.
Maltese: Żewġ studji oħra f'total ta' 1,012-il pazjent qabblu Insulin lispro Sanofi ma' Humalog u sabu li huma effettivi b'mod simili biex inaqqsu l-livelli ta' sustanza msejħa emoglobina glikosilata (HbA1c) fiddemm, li tagħti indikazzjoni ta' kemm qed jiġu kkontrollati tajjeb il-livelli tal-glukożju fid-demm mażżmien.
English: Other information about Insulin lispro Sanofi
Maltese: Informazzjoni oħra dwar Insulin lispro Sanofi
English: Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children with diabetes who need insulin.
Maltese: Insulin lispro Sanofi huwa mediċina li tintuża biex tikkontrolla l-livelli tal-glukożju (taz-zokkor) fiddemm f'adulti u fi tfal bid-dijabete li jkollhom bżonn l-insulina.
English: It can also be given with an infusion pump.
Maltese: Dan jista' ingħata wkoll b'pompa tal-infużjoni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements for biosimilar medicines, Insulin lispro Sanofi has a highly similar structure, purity and biological activity to Humalog and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Insulin lispro Sanofi għandu struttura, purità u attività bijoloġija simili ħafna għal Humalog u jiġi distribwit fil-ġisem bl-istess mod.
English: What are the risks associated with Insulin lispro Sanofi?
Maltese: -riskji asso ċjati ma' Insulin lispro Sanofi?
English: Why is Insulin lispro Sanofi approved?
Maltese: Għaliex ġie approvat Insulin lispro Sanofi?
English: Insulin lispro Sanofi is given as an injection under the skin in the upper arm, thigh, buttock or belly.
Maltese: Insulin lispro Sanofi jingħata bħala injezzjoni taħt il-ġilda fin-naħa ta' fuq tad-driegħ, fil-koxxa, filwarrani jew fiż-żaqq.
English: In addition, studies have shown that both medicines produce similar levels of the active substance in the body.
Maltese: Barra minn hekk, l-istudji wrew li ż-żewġ mediċini jipproduċu livelli simili tassustanza attiva fil-ġisem.
English: In addition, studies show that both medicines have similar effects in reducing blood glucose levels and similar side effects.
Maltese: Barra minn hekk, listudji juru li ż-żewġ mediċini għandhom effetti simili biex inaqqsu l-livelli tal-glukożju fid-demm u effetti sekondarji simili.
English: How does Insulin lispro Sanofi work?
Maltese: Insulin lispro Sanofi.
English: For the full list of all side effects and restrictions with Insulin lispro Sanofi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Insulin lispro Sanofi, ara l-fuljett ta' tagħrif.
English: Packaging Content Package size Withdrawal Period
Maltese: Ippakkjar Kontenut Daqs tal-pakkett Perjodu ta'
English: EU Number
Maltese: Tiżmim
English: Target species
Maltese: Użu Lokalizzat
English: CVMP/431317/06
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: 28 September 2012
Maltese: 28 ta' Settembru 2012
English: France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom).
Maltese: Finlandja, Franza, l-Ungerija, l-Islanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja, u r-Renju Unit).
English: Yvidually is a combined contraceptive pill.
Maltese: Yvidually hija pillola kontraċettiva kkombinata.
English: What is Yvidually?
Maltese: X'inhu Yvidually?
English: EMA/265750/2012 Rev. 1 EMEA/H/A-29/1330
Maltese: 1 EMEA/H/A-29/1330
English: It contains two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone.
Maltese: Fiha żewġ sustanzi attivi, ethinylestradiol u drospirenone, li huma miksubin minn ormoni naturali prodotti fl-ovarji: ethinylestradiol huwa miksub mill-estroġenu u drospirenone huwa miskub mill-progesterone.
English: Why was Yvidually reviewed?
Maltese: Għaliex ġie rivedut Yvidually?
English: Bayer B.V. submitted Yvidually to the Netherlands medicines regulatory agency for a decentralised procedure.
Maltese: Bayer B.V. ippreżentat Yvidually lill-aġenzija regolatorja tal-mediċini tal-Pajjiżi l-Baxxi għal proċedura deċentralizzata.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Finland,
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-'Istat Membru ta' referenza', f'dan ilkaż il-Pajjiżi l-Baxxi) jivvaluta mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-'Istati Membri kkonċernati', f'dan il-każ l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Ġermanja, il-Greċja, il
English: Yvidually is an ‘extended use' oral contraceptive, which means that it can be taken daily for up to 120 days.
Maltese: Yvidually huwa kontraċettiv orali ta' 'użu estiż', li jfisser li jista' jittieħed kuljum għal massimu ta' 120 jum.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Yvidually and associated names.
Maltese: Fid-19 ta' April 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost Stati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Yvidually u ismijiet assoċjati.
English: The option of a tablet-free interval at any time during day 25 to 120 of the treatment cycle is also allowed.
Maltese: L-għażla ta' intervall mingħajr pilloli fi kwalunkwe ħin matul jum 25 sa 120 taċ-ċiklu ta' kura hija permessa wkoll.
English: Yvidually will be available as tablets in an automated tablet dispenser device with a reminder function for when the next pill has to be taken.
Maltese: Yvidually sejjer ikun disponibbli bħala pilloli f'apparat dispenser tal-pilloli awtomatizzat b'funzjoni ta' tfakkira għal meta għandha tittieħed il-pillola li jmiss.
English: The CHMP also noted that the concerns over the tablet dispenser had been adequately addressed, as an additional study provided by the company showed that women find the dispenser easy to use and that there were no problems with posology compliance.
Maltese: Is-CHMP innota wkoll li t-tħassib dwar id-dispenser tal-pilloli ġie indirizzat b'mod adegwat, minħabba li studju addizzjonali pprovdut mill-kumpanija wera li nisa jsibu d-dispenser faċli biex jintuża u li ma kien hemm ebda problema bil-konformità mal-pożoloġija.
English: France was also concerned that the tablet dispenser had not been used in the main clinical studies.
Maltese: Franza kienet imħassba wkoll dwar il-fatt li d-dispenser tal-pilloli ma ntużax fl-istudji kliniċi prinċipali.
English: Yvidually works by changing the body's hormonal balance to prevent ovulation, by altering the mucus in the cervix (neck of the womb) and by thinning the endometrium (the lining of the womb).
Maltese: Yvidually jaħdem billi jibdel il-bilanċ ormonali tal-ġisem sabiex jimpedixxi l-ovulazzjoni, billi jibdel il-mukus fl-għonq tal-utru u billi jraqqaq l-endometriju (ir-rita tal-ġuf).
English: However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP for arbitration on 23 February 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil u l-Pajjiżi l-Baxxi rreferew il-kwistjoni lis-CHMP għal arbitraġġ fit-23 ta' Frar 2012.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Yvidually outweigh its risks, and the marketing authorisation can be granted in all EU Member States as well as Iceland and Norway.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Yvidually huma akbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fissuq tista' tingħata fl-Istati Membri tal-UE kollha kif ukoll fl-Islanda u fin-Norveġja.
English: This medicine will be marketed also as Flexyess.
Maltese: Din il-mediċina sejra tiġi kkummerċjalizzata wkoll bħala Flexyess.
English: The grounds for the referral were concerns by France about the effectiveness of the proposed extended use of the medicine and the irregular bleeding episodes that might occur during the days of intake of the pill.
Maltese: Filwaqt li ġew irrapportati tendenzi differenti fir-rigward ta' fsada matul il-jiem ta' teħid tal-pillola, dawn l-episodji ta' fsada jidher li ġew ittollerati tajjeb.