FrancophonIA/ELRC3.0 huggingface dataset:
English: It was also noted that the IS-CV was not as high for the 8mg and 16mg strengths (18% and 25%).
Maltese: Kien innutat ukoll li l-IS-CV ma kienx għoli daqshekk għallqawwiet ta' 8mg u 16mg (18% u 25%).
English: The reference product is Reminyl 8mg/16mg and 24mg in the form of prolonged release capsules.
Maltese: Il-prodott ta' referenza huwa Reminyl 8mg/16mg u 24mg fl-għamla ta' kapsuli b'rilaxx prolungat.
English: In the study protocol of the multiple dose study, AUCT and Cmaxss after the 24 mg dose were proposed as primary parameters (for which bioequivalence was shown in the conventional bioequivalence range), while Cminss was not defined as primary pharmacokinetic parameter.
Maltese: Fil-protokoll tal-istudju, tal-istudju bid-doża multipla, AUCT u Cmaxss wara d-doża ta' 24 mg ġew proposti bħala l-parametri primarji (li għalihom, il-bijoekwivalenza intweriet fil-firxa ta' bijoekwivalenza konvenzjonali), filwaqt li Cminss ma kienx definit bħala parametru farmakokinetiku primarju.
English: As apparent from the protocol, Cmin (defined as minimum drug concentration in the dosing interval) was pre-specified as secondary parameter (descriptive statistics) and descriptive Cmin data had already been reported in the initial submission.
Maltese: Kif jidher ċar mill-protokoll, Cmin (definit bħala konċentrazzjoni minima tal-mediċina fl-intervall taddożaġġ) kien speċifikat minn qabel bħala parametru sekondarju (statistika deskrittiva) u dejta deskrittiva għal Cmin kienet diġà ġiet irrapportata fis-sottomissjoni inizjali.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mod ta' kif jingħata, applikant fl-Istati Membri
English: Additionally the Applicant also presented as supportive data the peak-trough-fluctuation (%PTF) values for all three strengths and an analysis using repeated measurements of Cmin pd at days 10, 11 and 12 (i.e. at the 24 mg dose) of the multiple dose study.
Maltese: Barra minn hekk, l-Applikant ippreżenta wkoll bħala dejta ta' appoġġ, il-valuri tal-peak-troughfluctuation (%PTF) għat-tliet qawwiet kollha u analiżi li tuża kejl ripetut ta' Cmin pd fil-jiem 10, 11 u 12 (jiġifieri mad-doża ta' 24 mg) tal-istudju tad-doża multipla.
English: The Applicant was requested by the CHMP to provide justification for the choice of the method for Cmin calculation in the steady state study and also to discuss which definition of Cmin would best reflect the prolonged release characteristics of the product and allow detection of possible differences between test and reference product.
Maltese: L-Applikant kien mitlub mis-CHMP illi jipprovdi ġustifikazzjoni għall-għażla tal-metodu għall-kalkolu ta' Cmin fl-istudju ta' stat-stabbli u anki biex jiddiskuti liema definizzjoni ta' Cmin tkun tirrifletti l-aħjar ilkaratteristiċi ta' rilaxx prolungat tal-prodott u li tippermetti li jkunu identifikati differenzi possibbli bejn il-prodtt test u l-prodott ta' referenza.
English: A study at steady state with the highest strength (24 mg) after gradual dose increase (8 mg and
Maltese: Studju bi stat fiss bl-ogħla qawwa (24 mg) wara żieda gradwali tad-doża (8 mg u 16 mg għal 4
English: The intra-subject coefficient of variation (IS-CV) of Cminss was found to be markedly higher in comparison to Cmaxss (37.2 % vs. 11.1% for the 24mg strength).
Maltese: Il-koeffiċjent ta' varjazzjoni intra-soġġett (IS-CV) ta' Cminss instab li huwa ogħla sewwa meta mqabbel ma' Cmaxss (37.2 % vs.
English: A single dose study with 24 mg was considered to be acceptable due to the poor tolerability of galantamine in patients and in healthy volunteers, provided that the following multiple dose study was performed, which included the 24 mg dose:
Maltese: Studju ta' doża waħda ta' 24 mg kien ikkunsidrat aċċettabbli minħabba t-tolleranza baxxa għal galantamine f'pazjenti u f'voluntiera b'saħħithom, diment li jsir dan l-istudju b'dożi multipli, li kien jinkludi d-doża ta' 24 mg:
English: However the CHMP highlighted Section 5 of the current CPMP Note for Guidance on Modified Release Oral and Transdermal Dosage Forms (CPMP/EWP/280/96 corr), which states that the following applies for the steady state study:
Maltese: Oral and Transdermal Dosage Forms) (CPMP/EWP/280/96 corr), li tistqarr li dan li ġej japplika għallistudju bi stat stabbli: “Il-valutazzjoni tal-bijoekwivalenza għandha tkun ibbażata fuq AUCτ, Cmax u Cmin bl-applikazzjoni ta' proċeduri statistiċi simili għal dawk tal-formolazzjonijiet ta' rilaxx immedjat.
English: 1) Cminss defined as the lowest concentration on a concentration-time curve at steady-state within one dosing interval including the pre-dose concentration value.
Maltese: 1) Cminss definit bħala l-inqas konċentrazzjoni fuq kurva ta' konċentrazzjoni-ħin fi stat-stabbli fi ħdan intervall ta' dożaġġ wieħed inkluż il-valur ta' konċentrazzjoni ta' qabel id-doża.
English: GALANTAX XL 8 mg prolonged-release tablets
Maltese: XL 8 mg prolonged-release tablets 8 mg
English: GALANTAX XL 24 mg prolonged-release tablets 24 mg
Maltese: XL 24 mg prolonged-release tablets
English: In the case of prolonged release formulations, Cmin is usually lower than Ctrough.
Maltese: Fil-każ tal-formolazzjonijiet b'rilaxx prolungat, Cmin huwa normalment aktar baxx minn Ctrough.
English: Cminss and peak-trough fluctuation (PTF) were considered as secondary parameters as well as all pharmacokinetic parameters for the other two dosage strengths The multiple dose study was designed to mirror clinical conditions by up-titration of all three doses.
Maltese: Cminss u l-‘peak-trough flactuation' (PTF) kienu ikkunsidrati bħala parametri sekondarji kif ukoll il-parametri farmakokinetiċi għaż-żewġ qawwiet ta' dożaġġ l-oħrajn.
English: GALANTAX XL 16 mg prolonged-release tablets
Maltese: XL 16 mg prolonged-release tablets 16 mg
English: It was clear, that the way for computing Cmin as Cminss was preferred initially, and descriptive statistics for this parameter were submitted in the final study report.
Maltese: Kien ċar li, inizjalment kien ippreferut il-mod ta' komputazzjoni ta' Cmin bħala Cminss, u statistika deskrittiva għal dan ilparametru ġiet sottomessa fir-rapport finali tal-istudju.
English: The CHMP was therefore of the view that the risk benefit ratio of Galantamine STADA is negative and that a marketing authorization should not be granted.
Maltese: Għalhekk, is-CHMP kien tal-opinjoni li l-proporzjon ta' riskju benefiċċju ta' Galantamine STADA huwa negattiv u li l-awtorizzazzjoni għat-tqegħid fis-suq ma għandhiex tingħata.
English: The two other ways of calculations (Cpd and Ctrough) were conducted post hoc after it became apparent that prespecified Cminss data did not result in acceptable 90%CI.
Maltese: Iż-żewġ modijiet l-oħra għall-kalkoli (Cpd u Ctrough) saru post hoc wara li kien ċar li id-data Cminss speċifikata minn qabel ma wasslitx għal 90%CI aċċettabbli.
English: The CHMP concluded that bioequivalence had not been shown and that the pharmacokinetic characteristics suggest inferior performance of Galantamine STADA prolonged release capsules in comparison with the reference product.
Maltese: Jekk il-valuri Cmin tal-prodott tat-test għandhom it-tendenza li jonqsu aktar mill-prodott ta' referenza, wieħed jista' jistenna wkoll effikaċja klinika aktar baxxa tal-prodott tat-test.
English: The CHMP was of the view that Cmin is considered to be an important rate parameter especially in multiple dose bioequivalence studies, and that demonstration of bioequivalence is of paramount importance.
Maltese: Is-CHMP kien tal-opinjoni li Cmin huwa kkunsidrat bħala parametru tar-rata importanti speċjalment fi studji ta' bijoekwivalenza ta' dożi multipli, u li t-turija tal-bijoekwivalenza hija ta' importanza kbira.
English: Furthermore the pooling of the pre-dose concentrations (Cmin) in the steady state study at day 10/11/12 as a proof of bioequivalence instead of standard non-pooled data (replicate design), was not considered to be acceptable by the CHMP.
Maltese: Barra minn hekk, il-ġabra flimkien tal-konċentrazzjonijiet ta' qabel id-doża (Cmin) fl-istudju ta' stat stabbli fil-jum 10/11/12 bħala prova tal-bijoekwivalenza minflok id-dejta standard mhux miġbura flimkien (disinn ta' replika), ma kinitx ikkunsidrata aċċettabbli mis-CHMP.
English: The CHMP were of the view that the requirements of this guideline are clear and they are based on the principle that using a derived parameter (such as %PTF) for the pharmacokinetic evaluation decreases the sensitivity to detect a possible difference between products
Maltese: Is-CHMP kien tal-opinjoni li l-ħtiġijiet ta' din il-linja gwida huma ċari u huma bbażati fuq il-prinċipju li lużu ta' parametru derivat (bħal %PTF) għall-evalwazzjoni farmakokinetika inaqqas is-sensittività li tkun innutata differenza possibbli bejn il-prodotti.
English: • Bioequivalence issues
Maltese: • Kwistjonijiet ta' bijoekwivalenza
English: Overall summary of the scientific evaluation of Galantamine STADA and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika għal Galantamine STADA u ismijiet assoċjati (ara Anness I)
English: Strength Pharmaceutical Form Route of administration
Maltese: Għamla Farmaċewtika
English: Three single dose studies and one steady state study have been conducted to establish bioequivalence of the prolonged release tablets Galantamine STADA in comparison to the reference product Reminyl prolonged release capsules.
Maltese: Saru tlett studji ta' doża waħda u studju wieħed ta' stat stabbli għall-istabiliment tal-bijoekwivalenza tal-pilloli b'rilaxx prolungat ta' Galantamine STADA kif imqabbla mal-prodott ta' referenza Reminyl kapsuli ta' rilaxx prolungat.
English: The CHMP agreed that although there is no explicit recommendation for computing of Cmin for prolonged release products at the present time, recommendations connected to immediate release products cannot be extrapolated to prolonged release products, which differ from immediate release products with respect to the shape of the pharmacokinetic profile.
Maltese: Is-CHMP qabel li għalkemm bħalissa ma hemm l-ebda rakkomandazzjoni espliċita għall-komputazzjoni ta' Cmin għal prodotti ta' rilaxx prolungat, rakkomandazzjonijiet relatati ma' prodotti ta' rilaxx immedjat ma jistgħux jiġu estrapolati għal prodotti b'rilaxx prolungat, li huma differenti mill-prodotti ta' rilaxx immedjat fir-rigward tal-għamla tal-profil farmakokinetiku.
English: The Applicant explained that the
Maltese: L-Applikant
English: In addition, tmax was in the same range for both products.
Maltese: Barra minn hekk, tmax kien fl-istess firxa għaż-żewġ prodotti.
English: Packaging
Maltese: Daqs tal-pakkett
English: Pharmaceutical Form
Maltese: 14-il pillola
English: Invented name Strength
Maltese: Isem ivvintat Qawwa
English: Ref. EMEA/599866/2007
Maltese: EMEA/599866/2007
English: London, 24 January 2008 Doc.
Maltese: Londra, 24 ta' Jannar 2008 Doc.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment idum sa 210t ijiem biex jevalwa applikazzjoni ġdida.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni ta' l-applikazzjoni meta ġiet irtirata?
English: What is Sinerem?
Maltese: X'inhu Sinerem ?
English: Active substance: Superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate
Maltese: Nanopartiċelli superparamanjetiċi ta' l-ossidu tal-ħadid stabbilizzati b'dextran u sodium citrate
English: Once in the lymphatic system, the nanoparticles are taken up by a certain type of immune system cell called ‘macrophages' within the lymph nodes.
Maltese: Ladarba jkunu fis-sistema limfatika, in-nanopartiċelli jinħatfu minn tip ta' ċellola fis-sistema immunitarja magħrufin bħala ‘macrophages' fil-linfonodi.
English: The active substance in Sinerem is iron oxide in the form of nanoparticles in a clear, colloidal (jellylike) solution of dextran, a type of sugar.
Maltese: Is-sustanza attiva f'Sinerem huwa ossidu tal-ħadid fil-forma ta' nanopartiċelli f'soluzzjoni ċara, kollojdali (qisha ġeli) ta' dextran, tip ta' zokkor.
English: It contains extremely small particles of iron oxide (nanoparticles).
Maltese: Fih partiċelli żgħar immens ta' l-ossidu tal-ħadid (nanopartiċelli).
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun ipprovdiet it-tweġibiet għall-mistoqsijiet, is-CHMP jirrevedihom u jista', qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet oħra fil-180 jum.
English: On 13 December 2007, Guerbet officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sinerem, intended for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Maltese: Fit-13 ta' Diċembru ta' l-2007, Guerbet għarrfu uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) li jixtiequ jirtiraw l-applikazzjoni tagħhom għal awtorizzazzjoni għat-tqegħid fis-suq għal Sinerem li kellu jintuża għall-karatterizzazzjoni tal-linfonodi viżwalizzati blMRI (immaġni tar-reżonanza manjetika) fl-evalwazzjoni ta' tumuri primarji mifruxa fil-kankrijiet talpelvis.
English: The application was at day 175 when the company withdrew.
Maltese: L-applikazzjoni kienet fil-175 jum meta l-kumpanija rtirat.
English: Sinerem was to be used in patients with pelvic cancers.
Maltese: Sinerem kellu jintuża f'pazjenti b'kankru fil-pelvis.
English: Sinerem is a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Sinerem hu trab li jinħall biex jifforma soluzzjoni għall-infużjoni (dripp fil-vina).
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sinerem could not have been approved for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Maltese: Skond l-analiżi tad-dejta u t-tweġibiet tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fi żmien lirtirar, is-CHMP kellu xi tħassib u kien ta' l-opinjoni proviżorja li Sinerem ma setax jiġi approvat għal użu dijanjostiku għall-karatterizzazzjoni tal-linfonodi viżwalizzati bl-MRI (produzzjoni ta' immaġni bir-reżonanza manjetika) fl-evalwazzjoni tal-firxa tat-tumuri primarji fil-kankrijiet manjetiċi.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Skond l-analiżi taddokumentazzjoni inizjali, is-CHMP ħejja lista ta' misoqsijiet fil-120 jum, li tintbagħat lill-kumpanija.
English: How is Sinerem expected to work?
Maltese: Kif kien mistenni jaħdem Sinerem ?
English: Pelvic cancers are cancers affecting organs in the lower abdomen, such as the prostate gland, the bladder, the womb or the cervix.
Maltese: Il-kankrijiet tal-pelvis huma kankrijiet li jaffettwaw l-organi fin-naħa t'isfel taż-żaqq, bħall-prostata, il-borża ta' l-awrina, l-utru jew l-għonq ta' l-utru.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Sinerem?
Maltese: Għal xiex kien mistenni li jintuża Sinerem ?
English: What were the main concerns of the CHMP?
Maltese: X'kien irrakkomanda s-CHMP f'dak iż-żmien?
English: This should help making a difference between normal lymph nodes that contain macrophages and therefore magnetic particles, and lymph nodes that are invaded with cancer cells and contain fewer macrophages and fewer magnetic particles.
Maltese: Sinerem kellu jintuża biex ikun magħruf jekk il-kankru kienx qed jinfirex, billi jgħin filviżwalizzazzjoni tal-linfonodi tal-pazjent, li huma parti mis-sistema limfatika, rettikolat ta' strutturi fil-ġisem li għandhom x'jaqsmu mad-difiża tal-ġisem (is-sistema immunitarja).
English: The patients then had an operation to remove the lymph nodes, and the results of the scans were compared by three different specialist readers to the results obtained when looking at the lymph nodes under a microscope to see if they contained any cancer cells.
Maltese: Ilpazjenti mbagħad saritilhom operazzjoni biex jitneħħewlhom il-linfonodi, u r-riżultati ta' l-iskenns tqabblu minn tliet qarrejja speċjalisti differenti mar-riżultati miksuba meta wieħed iħares lejn illinfonodi taħt il-mikroskopju biex wieħed jara jekk fihomx xi ċelloli tal-kankru.
English: The very small size of the particles allows them to be carried in the body, and to enter the lymphatic system.
Maltese: Id-daqs żgħir ħafna tal-partiċelli jħallihom jinġarru fil-ġisem, u jidħlu fis-sistema limfatika.
English: 30 May 2013 EMA/318380/2013
Maltese: 25 ta' Lulju 2013 EMA/318380/2013
English: The CMDh is a medicines regulatory body representing the EU Member States.
Maltese: Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-UE.
English: The French decision followed a national review of the medicine by ANSM.
Maltese: Id-deċiżjoni Franċiża ġiet wara reviżjoni nazzjonali tal-mediċina mill-ANSM.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
Maltese: Fid-29 ta' Mejju 2013, il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u lProċedura Deċentralizzata - Bniedem (CMDh) approva b'maġġoranza (26:1) r-rakkomandazzjoni talKumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-Aġenzija Ewropea għallMediċini, li kkonkluda li l-benefiċċji ta' Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 mikrogramma) u l-mediċini ġeneriċi tiegħu huma akbar mir-riskji, bil-kundizzjoni li jittieħdu diversi miżuri sabiex jiġi minimizzat ir-riskju ta' tromboemboliżmu (il-formazzjoni ta' emboli fil-vini u l-arterji).
English: Diane 35 was first authorised in 1985.
Maltese: Diane 35 kien awtorizzat l-ewwel darba fl-1985.
English: This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
Maltese: Din ir-reviżjoni ssottolinjat avvenimenti tromboemboliċi serji u użu off-label estensiv ta' dawn il-mediċini bħala kontraċettiv biss.
English: • The review confirmed the rare and known risk of thromboembolism with Diane 35 and its generics.
Maltese: • Ir-reviżjoni kkonfermat ir-riskju rari u magħruf ta' tromboemboliżmu b'Diane 35 u l-mediċini ġeneriċi tiegħu.
English: • Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
Maltese: • It-tobba għandhom jiddiskutu mal-pazjenti tagħhom ir-riskju ta' tromboemboliżmu u fatturi ta' riskju bħaż-żieda fl-età, it-tipjip, l-obeżità u l-immobilità fit-tul.
English: These medicines work by blocking the effects of a class of hormones called androgens.
Maltese: Dawn ilmediċini jaħdmu billi jimblukkaw l-effetti ta' kategorija ta' ormoni msejħa androġeni.
English: The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Maltese: Ir-reviżjoni ta' Diane 35 u l-mediċini ġeneriċi tiegħu nbdiet fi Frar 2013 fuq talba ta' Franza, skont lArtikolu 107i tad-Direttiva 2001/83/KE, magħrufa wkoll bħala l-proċedura urġenti tal-Unjoni.
English: Data on the risk of arterial thromboembolism (ATE) with Diane and its generics are sparse and indicate that this risk is lower than for VTE.
Maltese: Id-dejta dwar irriskju ta' tromboemboliżmu fl-arterji (ATE) b'Diane u l-mediċini ġeneriċi tiegħu hija limitata u tindika li dan ir-riskju huwa aktar baxx milli għal VTE.
English: • In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
Maltese: • Fil-kura tal-alopeċja androġenetika u l-akne mingħajr karatteristiċi androġeniċi, id-dejta dwar leffikaċja hija limitata.
English: Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Maltese: Il-mediċini li fihom cyproterone acetate 2 mg u ethinylestradiol 35 mikrogrammi kienu approvati permezz ta' proċeduri nazzjonali u huma disponibbli b'riċetta ta' tabib taħt diversi ismijiet kummerċjali fl-Istati Membri kollha tal-UE ħlief Ċipru.
English: Diane 35 and its generics act also as hormonal contraceptives and stopping them means that you will have to use another form of contraception to prevent unwanted pregnancies.
Maltese: Diane 35 u l-mediċini ġeneriċi tiegħu jaġixxu wkoll bħala kontraċettivi ormonali u t-twaqqif tagħhom ifisser li tkun trid tuża forma oħra ta' kontraċezzjoni biex tevita tqala mhux mixtieqa.
English: The risk of blood clots in the veins with these medicines is 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Maltese: Ir-riskju ta' emboli fil-vini b'dawn il-mediċini huwa darba u nofs sa darbtejn ogħla milli għal kontraċettivi orali kombinati (COCs) li fihom levonorgestrel u jista' jkun simili għar-riskju b'kontraċettivi li fihom gestodene, desogestrel jew drospirenone.
English: • In terms of effectiveness, the available data support the use of Diane 35 and its generics in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism, in women of reproductive age.
Maltese: • F'termini ta' effikaċja, id-dejta disponibbli tappoġġa l-użu ta' Diane 35 u l-mediċini ġeneriċi tiegħu fil-kura ta' akne moderata sa severa relatata ma' sensittività għall-androġen u/jew l-irsutiżmu, f'nisa ta' età riproduttiva.
English: Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
Maltese: Minkejja r-rakkomandazzjoni tal-PRAC, l-ANSM ipproċediet bis-sospensjoni tal-awtorizzazzjoni għattqegħid fis-suq ta' dawn il-mediċini fi Franza.
English: These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Maltese: Dawn jinkludu l-għoti ta' materjal edukattiv lill-preskritturi u lill-pazjenti, li jissottolinja r-riskji ta' tromboemboliżmu, pereżempju lista ta' kontroll għall-preskritturi sabiex ikun assigurat li r-riskji, flimkien mas-sinjali u s-sintomi, jiġu diskussi mal-pazjent.
English: Observational studies have shown that the risk of venous thromboembolism (VTE) with these medicines is 1.5 to 2 times higher than for COCs containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Maltese: Studji ta' osservazzjoni wrew li r-riskju ta' tromboemboliżmu fil-vini (VTE) b'dawn il-mediċini huwa darba u nofs sa darbtejn ogħla milli għal COCs li fihom levonorgestrel u jista' jkun simili għar-riskju b'kontraċettivi li fihom gestodene, desogestrel jew drospirenone.