FrancophonIA/ELRC3.0 huggingface dataset:
English: Volibris is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Maltese: Volibris huwa mediċina li tintuża waħidha jew flimkien ma' mediċini oħra għall-kura ta' adulti b'ipertensjoni arterjali fil-pulmun (PAH).
English: As for all medicines, data on the use of Volibris are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Volibris hija ssorveljata kontinwament.
English: It must not be used in patients with idiopathic pulmonary fibrosis (long-term disease in which hard fibrous tissue continuously forms in the lungs), with or without secondary pulmonary hypertension (high blood pressure in the lungs).
Maltese: M'għandux jintuża f'pazjenti li jbatu minn fibrożi pulmonari idjopatika (marda fit-tul fejn jifforma kontinwament tessut fibruż iebes fil-pulmuni), b'ipertensjoni pulmonari sekondarja jew mingħajrha (pressjoni għolja tad-demm filpulmuni).
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Volibris should be 5 mg a day and the patient should be closely monitored by their doctor.
Maltese: Meta tittieħed maċ-ċiklosporina (mediċina li tnaqqas l-attività tas-sistema immunitarja) id-doża ta' Volibris għandha tkun 5 mg kuljum u l-pazjenti għandhom ikunu sorveljati mill-qrib mit-tabib tagħhom.
English: After 12 weeks of treatment, patients taking 5 mg Volibris once a day could walk an average of 36 m more while patients taking placebo had got worse and could walk 9 m less.
Maltese: Wara 12 ġimgħa ta' kura, il-pazjenti li kellhom jieħdu 5 mg Volibris darba kuljum setgħu jimxu medja ta' 36 m aktar filwaqt li l-pazjenti li kienu qed jieħdu l-plaċebo marru għall-agħar u setgħu jimxu 9 m inqas.
English: Volibris is used in patients with class II or III disease.
Maltese: Volibris jintuża f'pazjenti bilmarda tal-klassi II jew III.
English: The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to become narrow.
Maltese: Aktar informazzjoni dwar Volibris tista' tinstab fis-sit elettroniku tal-Aġenzija:
English: For the full list of side effects with Volibris, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Volibris, ara l-fuljett ta' tagħrif.
English: Because it might be able to cause birth defects, Volibris must not be used in pregnant women or in women who could become pregnant unless they are using reliable contraception.
Maltese: Minħabba li jista' jikkaġuna difetti fit-twelid, Volibris m'għandux jintuża f'nisa tqal jew f'nisa li jistgħu joħorġu tqal sakemm ma jkunux qegħdin jużaw kontraċezzjoni affidabbli.
English: Truxima (rituximab)
Maltese: Truxima (rituksimab)
English: The full EPAR for Truxima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/truxima.
Maltese: ema.europa.eu/medicines/human/EPAR/truxima.
English: Other information about Truxima
Maltese: Informazzjoni oħra dwar Truxima
English: Truxima received a marketing authorisation valid throughout the EU on 17 February 2017.
Maltese: Truxima ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-17 ta' Frar 2017.
English: Truxima contains the active substance rituximab.
Maltese: Truxima fih is-sustanza attiva rituksimab.
English: Truxima is a ‘biosimilar medicine'.
Maltese: Truxima huwa ‘mediċina bijosimili'.
English: In addition, the two medicines had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73% (43 of 59 patients) with MabThera.
Maltese: Barra minn hekk, iż-żewġ mediċini kellhom effetti komparabbli fuq is-sintomi tal-artrite: wara 24 ġimgħa, il-proporzjon ta' pazjenti li kellhom titjib ta' 20 % fil-punteġġ tas-sintomi (imsejjaħ ACR20) kien ta' 74 % (114 minn 155 pazjent) bi Truxima u ta' 73 % (43 minn 59 pazjent) b'MabThera.
English: The reference medicine for Truxima is MabThera.
Maltese: Il-mediċina ta' referenza għal Truxima hija MabThera.
English: What are the risks associated with Truxima?
Maltese: X'inhuma r-riskji assoċjati ma' Truxima?
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Maltese: Effetti sekondarji serji oħra jinkludu riattivazzjoni tal-epatite B (ritorn ta' infezzjoni attiva preċedenti fil-fwied bil-virus tal-epatite B) u infezzjoni severa rari magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML).
English: • severe rheumatoid arthritis (an inflammatory condition of the joints)
Maltese: • artrite rewmatojde severa (kondizzjoni infjammatorja tal-ġogi);
English: Extensive laboratory studies comparing Truxima with MabThera have shown that rituximab in Truxima is highly similar to rituximab in MabThera in terms of chemical structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li qabblu Truxima ma' MabThera wrew li rituksimab fi Truxima huwa simili ħafna għal rituksimab f'MabThera f'termini ta' struttura kimika, purità u attività bijoloġika.
English: Truxima has been compared with MabThera given into a vein in a study involving 372 patients with active rheumatoid arthritis.
Maltese: Truxima ġie mqabbel ma' MabThera mogħti ġo vina fi studju li fih ħadu sehem 372 pazjent bl-artrite rewmatojde attiva.
English: The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B lymphocytes (types of white blood cells).
Maltese: Is-sustanza attiva fi Truxima, ir-rituksimab, hija antikorp monoklonali (tip ta' proteina) imfassal biex jagħraf u jeħel ma' proteina msejħa CD20 preżenti fuq il-wiċċ tal-linfoċiti B (tipi ta' ċelloli bojod taddemm).
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer)
Maltese: • linfoma follikulari u linfoma diffuża mhux ta' Hodgkin b'ċelloli B kbar (żewġ tipi ta' linfomi mhux ta'
English: When rituximab attaches to CD20, it causes the death of B lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B lymphocytes are involved in joint inflammation).
Maltese: Meta r-rituksimab teħel ma' CD20, tikkawża l-mewt tal-linfoċiti B, u dan jgħin fil-linfoma u fisCLL (fejn il-linfoċiti-B ikunu saru kanċerużi) u fl-artrite rewmatojde (fejn il-linfoċiti B huma involuti flinfjammazzjoni tal-ġogi).
English: • moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (the linings of internal organs).
Maltese: • pemfigus vulgaris moderata għal severa, marda awtoimmuni karatterizzata b'infafet u erożjoni tal ġilda mifruxa u membrani mukużi (il-kisjiet tal-organi interni). ‘Awtoimmuni' tfisser li l-marda hija kkawżata mis-sistema immunitarja (id-difiżi naturali tal-ġisem) li tattakka ċ-ċelloli tal-ġisem stess.
English: The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Maltese: Il-kumpanija li tqiegħed Truxima fis-suq ser tipprovdi lit-tobba u lill-pazjenti li jużaw il-mediċina għallkondizzjonijiet mhux kanċerużi b'materjal edukattiv dwar il-ħtieġa li l-mediċina tingħata fejn ikun hemm faċilitajiet għar-risuxxitazzjoni disponibbli u dwar ir-riskju ta' infezzjoni, inkluż PML.
English: This means that Truxima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Truxima huwa simili ħafna għal mediċina bijoloġika oħra (il-”mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: The study showed that Truxima and MabThera led to similar levels of rituximab in the blood.
Maltese: L-istudju wera li Truxima u MabThera wasslu għal livelli simili ta' rituksimab fid-demm.
English: As for all medicines, data on the use of Truxima are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Truxima hija ssorveljata kontinwament.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Maltese: Jiġi bħala konċentrat sabiex isir soluzzjoni li għandha tingħata permezz ta' infużjoni (dripp) ġo vina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Truxima has a highly similar structure, purity and biological activity to MabThera 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, Truxima għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit bl-istess mod fil-ġisem.
English: The risk of such reactions decreases in subsequent infusions.
Maltese: Ir-riskju ta' dawn ir-reazzjonijiet jonqos f'infużjonijiet sussegwenti.
English: What measures are being taken to ensure the safe and effective use of Truxima?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Truxima?
English: The safety of Truxima has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Maltese: Is-sigurtà ta' Truxima ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza MabThera.
English: Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the medicines produced similar responses.
Maltese: Studji ta' appoġġ f'pazjenti blartrite rewmatojde u f'pazjenti b'linfoma follikulari avvanzata indikaw ukoll li l-mediċini pproduċew risponsi simili.
English: For the full list of side effects of Truxima, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Truxima, ara l-fuljett ta' tagħrif.
English: In GPA and MPA, destroying the B lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Maltese: F'GPA u f'MPA, il-qerda tal-linfoċiti B tnaqqas il-produzzjoni tal-antikorpi li huma maħsuba li għandhom rwol importanti fl-attakk tal-vażi tad-demm u jikkawżaw l-infjammazzjoni.
English: Side effects reported with Truxima are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Truxima huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: All these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Truxima ser jaġixxi bl-istess mod bħal MabThera f'termini ta' effikaċja u sigurtà fl-użu approvat tiegħu.
English: How does Truxima work?
Maltese: Kif jintuża Truxima?
English: In addition, a study comparing Truxima to MabThera in rheumatoid arthritis adult patients showed that both medicines are similarly effective.
Maltese: Barra minn hekk, studju li qabbel Truxima ma' MabThera f'pazjenti adulti bl-artrite rewmatojde wera li ż-żewġ mediċini għandhom effikaċja simili.
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Truxima if they have severe heart problems.
Maltese: Barra minn hekk pazjenti bl-artrite rewmatojde, b'GPA, b'MPA jew b'pemfigus vulgaris ma għandhomx jingħataw Truxima jekk ikollhom problemi tal-qalb serji.
English: EMA/601019/2014 EMEA/H/C/003951
Maltese: EMEA/H/C/003951
English: Budesonide/Formoterol Teva is a ‘hybrid medicine'.
Maltese: Budesonide/Formoterol Teva huwa ‘mediċina ibrida'.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li Budesonide/Formoterol Teva 160/4.5 mikrogrammi u 320/9 mikrogrammi wrew li għandhom profil ta' kwalità komparabbli u li huma ekwivalenti għall-qawwiet korrispondenti ta' Symbicort Turbohaler.
English: The reference medicine for Budesonide/Formoterol Teva is Symbicort Turbohaler.
Maltese: Il-mediċina ta' referenza għal Budesonide/Formoterol Teva hija Symbicort Turbohaler.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Budesonide/Formoterol Teva budesonide / formoterol
Maltese: Tagħrif ieħor dwar Budesonide/Formoterol Teva
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Budesonide/Formoterol Teva valida fl-Unjoni Ewropea kollha fid-19 ta' Novembru 2014.
English: Why is Budesonide/Formoterol Teva approved?
Maltese: Għaliex Budesonide/Formoterol ġie approvat?
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Budesonide/Formoterol Teva.
English: Budesonide/Formoterol Teva is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Maltese: Budesonide/Formoterol Teva jintuża wkoll biex itaffi s-sintomi tal-marda pulmonari ostruttiva kronika severa (COPD) fl-adulti li kellhom aggravamenti (feġġiet) tal-marda fil-passat minkejja kura regolari.
English: This summary was last updated in 11-2014.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 11-2014.
English: What are the benefits and risks of Budesonide/Formoterol Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Budesonide/Formoterol Teva?
English: Budesonide/Formoterol Teva is a medicine that contains the active substances budesonide and formoterol.
Maltese: Budesonide/Formoterol Teva huwa mediċina li fiha s-sustanzi attivi budesonide u l-formoterol.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva is given using a different inhaler.
Maltese: Dan ifisser li huwa simili għall-‘mediċina ta' referenza' li fiha l-istess sustanzi attivi, iżda Budesonide/Formoterol Teva jingħata bl-użu ta' inalatur differenti.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cells.
Maltese: Dan jaħdem b'mod simili għall-ormoni tal-kortikosterojdi prodotti b'mod naturali, u jnaqqas l-attività tassistema immunitarja billi jeħel ma' riċetturi f'diversi tipi ta' ċelloli immuni.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Maltese: Dan jista' jintuża f'pazjenti li l-marda tagħhom ma tkunx qiegħda tiġi kkontrollata sew bil-kura b'mediċina oħra tal-ażma msejħa kortikosterojdi u “agonisti tal-beta-2 li jaħdmu għal żmien qasir” li jittieħdu man-nifs, jew f'pazjenti li l-marda tagħhom qiegħda tiġi kkontrollata sew bil-kura bil-kortikosterojdi u b'“agonisti tal-beta-2 li jaħdmu għal żmien twil” li jittieħdu man-nifs.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Maltese: Budesonide jappartjeni għal grupp ta' mediċini antiinfjammatorji magħrufin bħala kortikosterojdi.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Budesonide/Formoterol Teva jintuża bl-aktar mod sigur possibbli.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles.
Maltese: Dan jaħdem billi jeħel ma' riċetturi magħrufin bħala riċetturi tal-beta-2 li jinsabu fil-muskoli.
English: Studies were carried out to show that Budesonide/Formoterol Teva is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Maltese: Studji li twettqu juru li Budesonide/Formoterol Teva huwa bijoekwivalenti għall-mediċina ta' referenza (jiġifieri jipproduċi l-istess livell tas-sustanza attiva fil-ġisem) u li ż-żewġ mediċini jaġixxu bl-istess mod.
English: The two active substances in Budesonide/Formoterol Teva are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Maltese: Iż-żewġ sustanzi attivi f'Budesonide/Formoterol Teva huma magħrufa sew u huma preżenti f'diversi mediċini użati biex jikkuraw l-ażma u COPD, jew waħedhom jew flimkien ma' mediċini oħrajn.
English: How does Budesonide/Formoterol Teva work?
Maltese: X'inhu Budesonide/Formoterol Teva u għal xiex jintuża?
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
Maltese: TAL-PRODOTT (SmPC)
English: Section 5.1 • “Terpenic derivatives may lower the epileptogenous threshold.”
Maltese: Sezzjoni 5.1 • “Id-derivattivi terpeniċi jistgħu jnaqqsu l-livell epileptoġenu.
English: Lactation
Maltese: Tqala
English: Section 4.2 • {(Invented) Name} is contraindicated in children less than 30 months (see section 4.3).
Maltese: Sezzjoni 4.2 • {Isem (Ivvintat)} huwa kontra-indikat fit-tfal taħt it-30 xahar (ara sezzjoni 4.3).
English: LABELLING
Maltese: TIKKETTAR
English: Section 4.3 “Hypersensitivity to the active substances or to any of the excipients” “Children less than 30 months” “Children with a history of epilepsy or febrile convulsion” “Recent history of anorectal lesion”
Maltese: Sezzjoni 4.3 - “Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti” - “Tfal taħt it-30 xahar” - “Tfal b'passat mediku ta' epilessija jew ta' aċċessjoni bid-deni” - “Episodju reċenti ta' ferita anorettali”
English: • “Do not use concomitantly with other products (medicinal or cosmetic) containing terpenic derivatives whatever the route of administration (oral, rectal, cutaneous, or pulmonary).”
Maltese: • “Tużahx flimkien ma' prodotti oħra (mediċinali jew kosmetiċi) li fihom id-derivattivi terpeniċi irrispettivament mill-mod ta' kif jingħata (orali, rettali, b'mod kutanju jew pulmonarju).
English: • “Do not administer at a dose higher than recommended due to an increased risk of adverse drug reactions and disorders related to overdosage (see section 4.9).”
Maltese: • “Tagħtix doża ogħla minn dik irrakkomandata minħabba żieda fir-riskju ta' reazzjonijiet avversi tal-mediċina u ta' disturbi relatati ma' doża eċċessiva (ara sezzjoni 4.9).
English: - Do not prolong the treatment over 3 days due to the possible risks related to the accumulation of terpenic derivatives (for example camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) in the body including the brain, in particular neuropsychological disorders; and the risk of rectal burning.” - “Do not administer at doses higher than recommended due to an increased risk of adverse drug reactions and overdosage related disorders.” - “As this product is inflammable, do not go near a flame.” “Pregnancy and breast-feeding: - Do not use during pregnancy or breast-feeding”
Maltese: - Il-kura m'għandhiex iddum iżjed minn 3 ijiem minħabba r-riskji li jista' jkun hemm relatati mal-akkumulazzjoni ta' derivattivi terpeniċi (per eżempju gamfra , cineole, niaouli, sagħtar selvaġġ, terpineol, terpine, citral, mentol u żjut essenzjali tal-labar tal-pina, tal-ewkaliptu u tatterpentina) fil-ġisem, inkulż fil-moħħ, b'mod partikulari f'disturbi newropsikoloġiċi; u r-riskju ta' ħruq fir-rettu.
English: • “If required, appropriate symptomatic treatment should be given in specialized care unit”.
Maltese: • “Jekk ikun hemm bżonn, għandha tingħata kura sintomatika adattata f'unità ta' kura speċjalizzata.”.
English: Section 4.9 • “Repeated and prolonged use may cause rectal burning.”
Maltese: Sezzjoni 4.9 • “Użu ripetut u fit-tul jista' jikkawża ħruq fir-rettu.
English: terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) whatever the administration route (oral, rectal, cutaneous or pulmonary).”
Maltese: - Tużax {Isem(Ivvintat)} waqt li qed tieħu wkoll prodotti oħra (mediċinali jew kosmetiċi) li fiħom derivattivi terpeniċi (per eżempju gamfra , cineole, niaouli, sagħtar selvaġġ, terpineol, terpine, citral, mentol u żjut essenzjali tal-labar tal-pina, tal-ewkaliptu u tat-terpentina) irrispettivament mill-mod ta' kif jingħata (orali, rettali, b'mod kutanju jew pulmonarju).”
English: • “Do not use in children less than 30 months”
Maltese: - Tużax waqt it-tqala u t-treddigħ”
English: ANNEX III
Maltese: ANNESS III EMENDI LI GĦANDHOM JIĠU INKLUŻI
English: There are no or limited amount of data from the use of {Active substance} in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata dwar l-użu ta'{Sustanza attiva} f'nisa tqal.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin ikunu ssodisfati mill-MAH(s):
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Maltese: Il-MAHs għandhom jidentifikaw popolazzjoni speċifika ta' pazjenti li għalihom il-benefiċċji tal-prodott ikunu akbar mir-riskju.
English: Annex IV Conditions for the lifting of the marketing authorisation
Maltese: Anness IV Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni għattqegħid fis-suq
English: Conditions for the lifting of the suspension of the Marketing Authorisations
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-Awtorizzazzjoni għatTqegħid fis-Suq
English: Thalidomide Celgene is available as capsules (50 mg).
Maltese: Thalidomide Celgene jiġi bħala kapsuli (50 mg).
English: Thalidomide Celgene received a marketing authorisation valid throughout the EU on 16 April 2008.
Maltese: Thalidomide Celgene ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis16 ta' April 2008.