FrancophonIA/ELRC3.0 huggingface dataset:
English: White opaque (size 4, 14.3 ± 0.3 mm) capsules with “DPH02” printed in black on the cap and “100” printed in black on the body.
Maltese: Kapsuli bojod, opaki (daqs 4, 14.3 ± 0.3 mm) b' "DPH02" stampati bl-iswed fuq il-kappa u "100" stampati bl-iswed fuq il- korp tal-kapsula
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma (see sections 4.4 and 5.3).
Maltese: Pazjenti rġiel għandhom jibqgħu jużaw metodu affidabbli ta' kontraċezzjoni waqt it-teħid ta' Miglustat Dipharma (ara sezzjonijiet 4.4 u 5.3).
English: Miglustat Dipharma 100 mg hard capsules
Maltese: Miglustat Dipharma 100mg kapsuli ibsin
English: Body surface area (m2) Recommended dose 200 mg three times a day 200 mg twice a day
Maltese: Erja tas-superfiċje talġisem (m2) Doża rrakkomandata 200 mg tliet darbiet kuljum200 mg darbtejn kuljum
English: • Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults.
Maltese: • Miglustat Dipharma huwa wżat għall-kura tal-marda ta' Gaucher ta' tip 1 ħafifa sa moderata fl-adulti.
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance accounting for 70-80% of the dose.
Maltese: Fil-biċċa l-kbira miglustat huwa eliminat permezz ta' eskrezzjoni renali, b'irkupru mill awrina tal-mediċina mhux mibdula li jammonta għal 70-80% tad-doża.
English: Miglustat Dipharma 100 mg hard capsules miglustat
Maltese: Miglustat Dipharma 100 mg kapsuli ibsin miglustat
English: Dosage in Niemann-Pick type C disease
Maltese: • Għall-marda ta' Niemann-Pick ta' tip Ċ:
English: Miglustat Dipharma is a white opaque 100 mg capsule with “DPH02” printed in black on the top and “100” printed in black on the body.
Maltese: Miglustat Dipharma huwa abjad opak ta '100 mg kapsula b' "DPH02" stampat bl-iswed fuq il-quċċata u "100" stampat bl-iswed fuq il- korp tal-kapsula.
English: Each capsule contains 100 mg miglustat.
Maltese: Kull kapsula iebsa fiha 100 mg miglustat.
English: Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Maltese: (tneħħija tal-krejatinina ta' <30 ml/min/1.73 m2) mhuwiex irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: The most common serious adverse reaction reported with miglustat treatment in clinical trials was peripheral neuropathy (see section 4.4).
Maltese: L-aktar reazzjoni avversa komuni u serja rrappurtata b'kura ta' miglustat fi studji kliniċi kienet newropatija periferali (ara sezzjoni 4.4).
English: The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Maltese: inibizzjoni fuq glucosylceramide synthase hi r-raġuni għat-terapija tat-tnaqqis tas-sottostrat (substrate reduction therapy) fil-marda ta' Gaucher.
English: Pack size of 84x1 capsules in perforated unit dose blisters.
Maltese: Daqs tal-pakkett ta' 84x1 f'folji perforati ta' doża ta' unità waħda.
English: The usual treatment for type 1 Gaucher disease is enzyme replacement therapy.
Maltese: Marda ta' Gaucher ta' Tip 1 Għalkemm ma saru l-ebda paraguni diretti ma' Terapija tas-Sostituzzjoni tal-Enzimi (Enzyme
English: Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Maltese: Miglustat Dipharma fih is-sustanza attiva miglustat li tappartieni għal grupp ta' mediċini li jaffettwaw il-metaboliżmu.
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Maltese: Replacement Therapy - ERT) f'pazjenti bil-marda ta' Gaucher ta' tip 1 li qatt ma ġew ikkurati qabel, m'hemmx evidenza li miglustat għandu vantaġġ ta' effikaċja jew ta' sigurtà fuq ERT. ERT hi l-kura standard għall-pazjenti li jeħtieġu kura għall-marda ta' Gaucher ta' tip 1 (ara sezzjoni 5.1).
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Maltese: 50-70 ml/min/1.73 m2, l-għoti għandu jinbeda b'doża ta' 100 mg darbtejn kuljum f'pazjenti bil-marda ta' Gaucher ta' tip 1, u b'doża ta' 200 mg darbtejn kuljum (aġġustata għal erja tas-superfiċje tal-ġisem f'pazjenti taħt l-età ta' 12-il sena) f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ.
English: 100 mg once a day
Maltese: 100 mg darbtejn kuljum
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Dipharma (see section 4).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża tiegħek, eż., għall-kapsula waħda (100 mg) darba jew darbtejn kuljum, jekk inti ssofri minn dijarea meta tieħu Miglustat Dipharma (ara sezzjoni 4).
English: Detailed information on this medicinal prodcut is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Thrombocytopenia Metabolism and nutrition disorders Very common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Use of Miglustat Dipharma in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Maltese: L-użu ta' Miglustat Dipharma f'pazjenti b'indeboliment kbir tal-kliewi (b'rata ta' tneħħija tal-krejatinina ta' < 30 ml/min/1.73 m2) mhux irrakkomandat.
English: The apparent volume of distribution of miglustat is 83 L. Miglustat does not bind to plasma proteins.
Maltese: Miglustat ma jeħilx mal-proteini talplażma.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical trials in patients treated with miglustat 100 mg t.i.d.
Maltese: Manifestazzjonijiet fl-għadam tal-marda ta' Gaucher tat-tip 1 kienu evalwati fi 3 studji kliniċi openlabel f'pazjenti kkurati b'miglustat 100 mg t.i.d. għal perijodu sa sentejn (n = 72).
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Maltese: Tagħrif farmakokinetiku kien miksub minn pazjenti pedjatriċi bil-marda ta' Gaucher ta' tip 3 b'età minn 3 snin sa 15-il sena u minn pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ b'età minn 5 snin sa16
English: • Miglustat Dipharma is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Maltese: • Miglustat Dipharma huwa wżat ukoll għall-kura ta' sintomi newroloġiċi progressive fil-marda ta' Niemann-Pick ta' tip Ċ fl-adulti u t-tfal.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
Maltese: Meta mqabbel mar-riżultati wara 6 xhur, il-kontroll tal-marda baqa' ma nbidilx wara 18 u 24 xahar ta' monoterapija ta' miglustat
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 agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Your doctor can give you more information.
Maltese: Sorsi oħra ta 'informazzjoni
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma.
Maltese: Għandek tuża metodu ta' kontraċezzjoni effettiv waqt li tieħu Miglustat Dipharma.
English: The most common adverse reactions reported in clinical trials with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati fi studji kliniċi b'miglustat kienu dijarea, gass flistonku, uġigħ addominali, telf ta' piż u rogħda (ara sezzjoni 4.4).
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Maltese: Avvenimenti gastro-intestinali, prinċipalment dijarea, kienu osservati f'aktar minn 80% tal-pazjenti,
English: Dosage in type 1 Gaucher disease
Maltese: Dożaġġ fil-marda ta' Gaucher ta' tip 1
English: Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
Maltese: Gaucher ta' tip 1, u 40 kellhom il-marda ta' Niemann-Pick ta' tip Ċ.
English: After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Maltese: 17.5% u 29.6%, rispettivament.
English: Miglustat has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Maltese: Miglustat ma ġiex studjat f'pazjenti b'passat ta' mard gastro-intestinali sinifikanti, inkluż il-marda ta'
English: Pack size of 84 capsules in non-perforated blisters.
Maltese: Daqs tal-pakkett daqs ta' 84 kapsula f'folji mhux imtaqqbin.
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Maltese: Tqalligħ, rimettar, nefħa/skumdità addominali, stitikezza,
English: The benefit of treatment with miglustat for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with miglustat (see section 4.4).
Maltese: Niemann-Pick ta' tip Ċ għandu jiġi evalwat fuq bażi regolari, eż. kull 6 xhur; jekk għandhiex titkompla it-terapija għandu jiġi ivvalutat mill-ġdid wara mill-inqas sena ta' kura b'miglustat, (ara sezzjoni 4.4).
English: Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Maltese: Miglustat Dipharma jista' jintuża biss għall-kura ta' dawk il-pazjenti fejn it-terapija ta' sostituzzjoni ta' l-enzimi mhijiex adattata (ara sezzjonijiet 4.4 u 5.1).
English: Miglustat Dipharma works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Maltese: Miglustat Dipharma jaħdem billi jinibixxi l-enzima msejjħa ‘glucosylceramide synthase' li hija responsabbli għallewwel pass fis-sintesi tal-biċċa l-kbira tal-glycosphingolipids.
English: This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures.
Maltese: Dan jista' jwassal għal disturbi fil-funzjoni newroloġika bħal moviment bilmod ta' lgħajnejn, disturbi fil-bilanċ, biex tibla', u fil-memorja, u aċċessjonijiet.
English: Miglustat Dipharma may make you feel dizzy.
Maltese: Miglustat Dipharma jista' jikkawża sturdament.
English: Among the 41 patients enrolled in the trial 14 patients were treated with miglustat for more than 3 years.
Maltese: Fost il-41 pazjent li ħadu sehem fil-prova 14-il pazjent kienu kkurati b'miglustat għal aktar minn 3 snin.
English: Elderly There is no experience with the use of miglustat in patients over the age of 70.
Maltese: Anzjani M'hemmx esperjenza bl-użu ta' miglustat f'pazjenti b'età 'l fuq minn 70 sena.
English: Capsule shell Gelatine
Maltese: Qoxra tal-kapsula
English: There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Maltese: Hemm relazzjoni mill-qrib bejn il-funzjoni tal-kliewi u t- tneħħija ta' miglustat, u l-espożizzjoni għal miglustat tiżdied ħafna f'pazjenti b'indeboliment serju tal- kliewi (ara sezzjoni 5.2).
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Maltese: Miglustat kien studjat f'indikazzjonijiet fejn ċertu avvenimenti rrapportati bħala reazzjonijiet avversi, bħal sintomi/sinjali newroloġiċi u newropsikoloġiċi, disfunzjoni konoxxittiva u tromboċitopenja jista' jkunu kkawżata wkoll mill-marda li ġa hemm.
English: Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Maltese: Il-marda ta' Gaucher hi marda metabolika li tintiret ġenetikament li hi kkawżata min-nuqqas filkapaċità tal-ġisem biex ikisser il-glucosylceramide, li jirriżulta fil-ħżin ta' lysosomal ta' dan il-materjal u f'patoloġija mifruxa.
English: This means a daily maximum of six capsules (600 mg).
Maltese: Dan ifisser massimu ta' sitt kapsuli kuljum (600 mg).
English: The greatest prevalence was observed between 6 and 12 months.
Maltese: L-ikbar prevalenza kienet osservata bejn 6 u 12-il xahar.
English: Check with your doctor or pharmacist if you are not sure.For typer 1 Gaucher disease: For adults the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Maltese: • Għall-marda ta' Gaucher ta' tip 1: Għall-adulti, id-doża tas-soltu hija kapsula (100 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
English: Overall the data show that treatment with miglustat can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Maltese: Globalment it-tagħrif wera li kura b'miglustat tista' tnaqqas il-progressjoni tas-sintomi newroloġiċi klinikament rilevanti f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ.
English: Other medicines and Miglustat Dipharma
Maltese: Mediċini oħra u Miglustat Dipharma
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Maltese: Meta miglustat jittieħed ma' l-ikel, ir-rata ta' l-assorbiment tonqos (Cmax naqset b'36% u tmax intlaħaq sagħtejn iktar tard min-normal), imma dan m'għandu l-ebda effett statistikament sinifikanti fuq lammont ta' assorbiment ta' miglustat (AUC naqset b'14%).
English: The neurological manifestations are considered secondary to the abnormal accumulation of glycosphingolipids in neuronal and glial cells.
Maltese: glycosphingolipids fiċ-ċelluli newronali u glijali.
English: An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Maltese: Studju open-label, mhux komparattiv ta' sentejn kien jinvolvi 42 pazjenti bil-marda ta' Gaucher ta' tip
English: No.
Maltese: Le.
English: EMA/527628/2011 Rev. 1 Directorate
Maltese: EMA/527628/2011 Rev.
English: Questions about competing interests and transparency
Maltese: Mistoqsijiet dwar interessi kunfliġġenti u trasparenza
English: Questions about the Agency
Maltese: 1 Direttorat
English: 13 February 2017
Maltese: 13 ta' Frar 2017
English: Frequently asked questions EMA/527628/2011
Maltese: Mistoqsijiet frekwentiEMA/527628/2011
English: These 'Community herbal monographs'
Maltese: Dawn il-'monografiji erbali tal
English: • cosmetics.
Maltese: • il-prodotti kożmetiċi.
English: How can I get onto a clinical trial?
Maltese: Kif nista' nieħu sehem fi prova klinika?
English: • herbal supplements;
Maltese: • is-supplimenti erbali;
English: The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
Maltese: 00am sal-5.30pm, mit-Tnejn sal-Ġimgħa.
English: How is the financial transparency of patient and consumer organisations evaluated?
Maltese: Kif inhi vvalutata t-trasparenza finanzjarja tal-organizzazzjonijiet talpazjenti u tal-konsumaturi?
English: Frequently asked questions
Maltese: Mistoqsijiet frekwenti
English: Some content is translated into other official European Union (EU) languages, including public summaries and product information in European public assessment reports (EPARs), question-and-answer documents for the public, information on recruitment, work programmes and summaries of the annual report.
Maltese: Xi kontenut huwa tradott f'lingwi uffiċjali oħrajn tal-Unjoni Ewropea (UE), inkluż sommarji pubbliċi u informazzjoni dwar il-prodott f'rapporti pubbliċi Ewropej ta' valutazzjoni (EPARs), dokumenti ta' mistoqsija u tweġiba għall-pubbliku, informazzjoni dwar ir-reklutaġġ, programmi ta' ħidma u sommarji tar-rapport annwali.
English: Questions about clinical trials
Maltese: Mistoqsijiet dwar provi kliniċi
English: Can the Agency tell me when a medicine will be approved?
Maltese: L-Aġenzija tista' tgħidli meta ser tiġi approvata mediċina?
English: Page 8/15
Maltese: Paġna 8/15
English: Fees are adjusted each year for inflation.
Maltese: Il-ħlasijiet jiġu aġġustati kull sena minħabba l-inflazzjoni.
English: Can the Agency supply me with branded merchandise?
Maltese: Kif inhuma vvalutati l-prodotti kożmetiċi?
English: For the Committee for Advanced Therapies, the Committee (CAT) for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), EMA publishes monthly meeting reports in the week following the committee's plenary meeting.
Maltese: Għall-Kumitat għat-Terapiji Avvanzati, il-Kumitat (CAT) għall-Prodotti Mediċinali Orfni (COMP) u lKumitat Pedjatriku (PDCO), l-EMA tippubblika rapporti dwar il-laqgħat fix-xahar fil-ġimgħa wara llaqgħa plenarja tal-kumitat.
English: They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.
Maltese: Normalment ma jiġux ivvalutati mill-awtoritajiet regolatorji talmediċini, sakemm ma jkunx fihom sustanza li jkollha attività farmakoloġika jew jaffermaw użu mediċinali.
English: • the availability of medicines;
Maltese: • id-disponibbiltà tal-mediċini;
English: How are the Agency's committee members selected?
Maltese: Istati Membri?
English: • authorised through national procedures and not centrally through EMA.
Maltese: • tkun awtorizzata permezz ta' proċeduri naturali u mhux ċentralment mill-EMA.
English: I am experiencing a side effect from a medicine.
Maltese: Qed nesperjenza effett sekondarju minn mediċina.
English: What type of information is available on a medicine evaluated by the Agency?
Maltese: X'tip ta' informazzjoni hija disponibbli dwar mediċina vvalutata millAġenzija?
English: • homoeopathic medicines;
Maltese: • il-mediċini omeopatiċi;
English: No. Advertising of medicines is controlled by medicines regulatory authorities in Member States and other national regulatory bodies, together with self-regulation by the pharmaceutical industry.
Maltese: Ir-riklamar ta' mediċini huwa kkontrollat mill-awtoritajiet regolatorji tal-mediċini fl-Istati Membri u korpi regolatorji nazzjonali oħrajn, flimkien ma' awtoregolazzjoni mill-industrija farmaċewtika.
English: Page 7/15
Maltese: Paġna 7/15
English: For information on clinical trials, talk to your doctor or nurse.
Maltese: Għal informazzjoni dwar provi kliniċi, kellem lit-tabib jew l-infermier tiegħek.
English: How are herbal medicines evaluated?
Maltese: Kif inhuma vvalutati l-mediċini erbali?
English: These include clinical trials and compassionate-use programmes, which Member Sates regulate.
Maltese: Dawn jinkludu provi kliniċi u programmi ta' użu ta' kompassjoni, li jirregolaw l-Istati Membri.
English: Page 10/15
Maltese: Paġna 10/15
English: Page 11/15
Maltese: Paġna 11/15
English: The Agency is not involved in recruiting volunteers for clinical trials.
Maltese: L-Aġenzija mhijiex involuta fir-reklutaġġ ta' volontiera għal provi kliniċi.
English: In the European Union (EU), herbal medicines are authorised by medicines regulatory authorities in Member States.
Maltese: Fl-Unjoni Ewropea (UE), il-mediċini erbali huma awtorizzati minn awtoritajiet regolatorji tal-mediċini flIstati Membri.
English: Page 9/15
Maltese: Paġna 9/15
English: To help us direct your query to the right people within the Agency, please indicate whether you are making your enquiry for personal reasons (e.g. a patient or carer, a student, a researcher, a healthcare professional, etc.) or on behalf of an organisation.
Maltese: Sabiex tgħinna ngħaddu l-mistoqsija tiegħek lill-persuni l-aktar xierqa fl-Aġenzija, jekk jogħġbok indika jekk intix qed tagħmel il-mistoqsija tiegħek għal raġunijiet personali (eż. pazjent jew dawk li jieħdu ħsieb il-pazjenti, student, riċerkatur, professjonista fil-kura tas-saħħa, eċċ.) jew f'isem organizzazzjoni.
English: Page 6/15
Maltese: Paġna 6/15
English: If you would like to take part in a clinical trial, you should discuss it with your doctor or nurse, who may be able to refer you for a suitable trial.
Maltese: Jekk tixtieq tieħu sehem fi prova klinika, għandek tiddiskuti dan mat-tabib jew mal-infirmier tiegħek, li forsi jkun jista' jirreferik għal prova xierqa.
English: Page 12/15
Maltese: Paġna 12/15
English: Page 4/15
Maltese: Paġna 4/15
English: Page 14/15
Maltese: Paġna 14/15
English: If you wish to use an acronym for the Agency, use 'EMA'.
Maltese: Jekk tixtieq tuża akronimu għall-Aġenzija, uża 'EMA'.
English: Questions about medical advice
Maltese: Mistoqsijiet dwar mediċini
English: Page 13/15
Maltese: Paġna 13/15
English: Page 5/15
Maltese: Paġna 5/15
English: • browsing the A-to-Z list of human or veterinary medicines evaluated by the Agency;
Maltese: • tfittex fil-lista mill-A saż-Z ta' mediċini li ġew ivvalutati mill-Aġenzija għall-użu tal-bniedem u għall użu veterinarju;
English: • medical devices;
Maltese: • l-istrumenti mediċi;
English: For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights with evaluation outcomes of major public interest on the Friday following their monthly plenary meetings.
Maltese: Għall-Kumitat għall-Prodotti Mediċinali għall-Użu mil-Bniedem (CHMP) u għall-Kumitat dwar ilValutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), l-EMA tippubblika punti ewlenin tal-laqgħat birriżultati tal-valutazzjoni ta' interess pubbliku maġġuri l-Ġimgħa wara l-laqgħat plenarji fix-xahar tagħhom.
English: • searching by keyword;
Maltese: • is-supplimenti tal-ikel;
English: In the European Union (EU), there are two ways of getting a marketing authorisation for a medicine: the centralised procedure, via the Agency, which results in a single marketing authorisation valid throughout the EU; national authorisation procedures, where individual EU Member States authorise medicines for use in their own territory.
Maltese: Fl-Unjoni Ewropea (UE), awtorizzazzjoni għat-tqegħid fis-suq għal mediċina tista' tinkiseb b'żewġ modi: il-proċedura ċentralizzata, permezz tal-Aġenzija, li tirriżulta f'awtorizzazzjoni għat-tqegħid fis-suq waħda valida fl-UE kollha; proċeduri ta' awtorizzazzjoni nazzjonali, fejn Stati Membri individwali tal-UE jawtorizzaw mediċini għallużu fit-territorju tagħhom stess.
English: Each EPAR includes a summary for the public
Maltese: Dawn huma disponibbli għall-pubbliku.
English: The Agency also publishes a monthly newsletter called 'human medicines highlights', which provides key information on the Agency's recent activities on human medicines.
Maltese: Informazzjoni dwar mediċini awtorizzati fl-Istati Membri individwali permezz ta' proċeduri nazzjonali tista' tinkiseb biss permezz tal-awtoritajiet nazzjonali regolatorji tal-mediċini.
English: Page 15/15
Maltese: Paġna 15/15