FrancophonIA/ELRC3.0 huggingface dataset:
English: Why was Levonelle reviewed?
Maltese: Għaliex ġie rieżaminat Levonelle?
English: On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Maltese: Fis-17 ta' Settembru 2014, il-kumpanija ta' Levonelle applikat għal bidla fl-awtorizzazzjoni għat-tqegħid fis-suq sabiex tinkludi l-mediċina ta' kontra l-HIV, efavirenz, bħala mediċina ta' interazzjoni fl-informazzjoni tal-prodott.
English: Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Maltese: Għalkemm l-Istati Membri qablu li efavirenz jinteraġixxi ma' levonorgestrel u li din l-informazzjoni għandha tkun inkluża fl-informazzjoni tal-prodott, l-Istati Membri ma kinux kapaċi jilħqu ftehim dwar kif din l-interazzjoni għandha tiġi mmaniġġjata u jekk ir-rakkomandazzjonijiet speċifiċi bħallaġġustament tad-doża kinux meħtieġa għan-nisa li jieħdu Levonelle waqt li jkunu qed jieħdu efavirenz jew mediċini oħra li jnaqqsu wkoll il-livell ta' levonorgestrel. Fl-1 ta' Ottubru 2015, ir-Renju Unit irrefera l-kwistjoni lis-CHMP għal arbitraġġ.
English: The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Maltese: Is-CHMP irrakkomanda li n-nisa li jużaw l-indutturi tal-enzima tal-fwied għandhom minflok jużaw kontraċettiv ta' emerġenza mhux ormonali (jiġifieri apparat tar-ram ta' ġewwa l-utru) li mhuwiex affetwat minn mediċini li jinduċu l-enzima tal-fwied.
English: EMA/311892/2014 EMEA/H/C/002546
Maltese: EMEA/H/C/002546
English: 23 May 2014
Maltese: 23 ta' Mejju 2014
English: It was to be available as capsules.
Maltese: Kellu jiġi bħala kapsuli.
English: Nerventra is a medicine that contains the active substance laquinimod.
Maltese: Nerventra huwa mediċina li fiha s-sustanza attiva lakwinimod.
English: Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Maltese: Rifjut tal-awtorizzazjoni għat-tqegħid fis-suq għal Nerventra (laquinimod) EMA/405467/2014
English: What is Nerventra?
Maltese: Kif huwa mistenni li jaħdem Nerventra?
English: The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a.
Maltese: Wieħed mill-istudji li involva 1,106 pazjenti qabbel Nerventra ma' plaċebo (trattament finta), filwaqt li t-tieni studju f'1,331 pazjent qabbel Nerventra ma' plaċebo u mediċina oħra li tintuża biex tikkura MS, interferon-beta 1a.
English: The company that applied for authorisation is Teva Pharma GmbH.
Maltese: Il-kumpanija li applikat għallawtorizzazjoni hija Teva Pharma
English: Refusal of the marketing authorisation for Nerventra (laquinimod)
Maltese: Rifjut tal-awtorizzazjoni għat-tqegħid fis-suq għal Nerventra (laquinimod)
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Maltese: Wara li qies ir-raġujnijiet għal din it-talba, isCHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazjoni għat-tqegħid fis-suq fit-22 ta' Mejju 2014.
English: Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
Maltese: Nerventra kien mistenni li jintuża għall-sklerożi multipla (MS), marda fejn is-sistema immunitarja ma taħdimx sew, u tikkawża infjammazzjoni li teqred l-għant protettiv madwar in-nervituri fil-moħħ u lkorda spinali.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Maltese: Fit-23 ta' Jannar 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazjoni għat-tqegħid fis-suq għall-prodott mediċinali Nerventra, maħsub għall-kura tal-isklerożi multipla.
English: What was Nerventra expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Nerventra?
English: Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Maltese: Nerventra kien mistenni li jintuża għat-tip ta' MS magħrufa bħala MS remittenti rikadenti, fejn ilpazjent ikollu flare-ups tas-sintomi (rikaduti) segwiti b'perjodi ta' rkupru (remissjonijiet).
English: The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Maltese: Il-mod eżatt ta' kif jaħdem Nerventra mhuwiex magħruf, iżda huwa maħsub li għandu effett modulatur fuq is-sistema immunitarja (id-difiża tal-ġisem).
English: During the re-examination, the CHMP considered advice from an expert group in neurology.
Maltese: Waqt l-eżaminazzjoni mill-ġdid, is-CHMP ikkunsidra pariri minn grupp espert fin-newroloġija.
English: The effects of Nerventra were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Nerventra ġew l-ewwel ittestjati f'mudelli esperimentali qabel ma ġew studjati fil-bniedem.
English: The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Maltese: Minbarra dan, il-Kumitat ma kienx konvint mill-effikaċja tal-miżuri proposti mill-kumpanija għall-prevenzjoni ta' tqala f'nisa li jieħdu l-mediċina.
English: The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis.
Maltese: Jekk qed tiehu sehem fi prova klinika u għandek bżonn iktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li qed jagħtihielek.
English: At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.
Maltese: Il-grupp espert ta l-parir li r-riskji li dehru fl-istudji fl-annimali kienu jkunu aċċettabli kieku deher benefiċċju ċar fl-istudji kliniċi, għalkemm skema stretta ta' prevenzjoni ta' tqala kienet tkun meħtieġa.
English: EMA/510659/2015
Maltese: EMA/510659/2015 EMEA/H/C/003776
English: The full EPAR and risk management plan summary for Fexeric 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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom jifforma kompost li mbagħad jiġi eliminat mal-ippurgar.
English: Other information about Fexeric
Maltese: Informazzjoni oħra dwar Fexeric
English: Fexeric is available as 1 g tablets.
Maltese: Fexeric jiġi bħala pilloli ta' 1 g.
English: This is a summary of the European public assessment report (EPAR) for Fexeric.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fexeric.
English: In the first study, Fexeric was as effective as sevelamer carbonate, an approved medicine, in lowering phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both treatments resulted in a reduction in phosphate levels of around 2 mg/dl.
Maltese: Fl-ewwel studju, Fexeric kien effikaċi daqs sevelamer carbonate, mediċina approvata, fit-tnaqqis tallivelli ta' fosfat f'359 pazjent b'mard tal-kliewi fit-tul: wara 12-il ġimgħa ż-żewġ kuri rriżultaw fi tnaqqis fil-livelli ta' fosfat ta' madwar 2 mg/dl.
English: What are the risks associated with Fexeric?
Maltese: X'inhuma r-riskji assoċjati ma' Fexeric?
English: The active substance in Fexeric, ferric citrate coordination complex, is a phosphate binder.
Maltese: Is-sustanza attiva f'Fexeric, il-kumpless ta' koordinazzjoni taċ-ċitrat ferriku, hija sustanza li teħel malfosfat.
English: The maximum dose is 12 tablets per day.
Maltese: Id-doża massima hija ta' 12-il pillola kuljum.
English: The study showed that blood-phosphate levels fell on average by 0.7 mg/dl with Fexeric compared with 0.3 mg/dl with placebo.
Maltese: L-istudju wera li l-livelli ta' fosfat fid-demm bħala medja naqsu b'0.7 mg/dl b'Fexeric meta mqabbel ma' 0.3 mg/dl bi plaċebo.
English: It contains the active substance ferric citrate coordination
Maltese: Fih is-sustanza attiva kumpless ta' koordinazzjoni taċ-ċitrat ferriku.
English: Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease.
Maltese: Fexeric huwa mediċina li tintuża biex tikkontrolla iperfosfatemija (livelli għoljin ta' fosfat fid-demm) f'adulti b'mard tal-kliewi fit-tul.
English: In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months.
Maltese: Fit-tieni studju, 149 pazjent li ma kinux fuq dijalisi rċevew Fexeric jew plaċebo għal 3 xhur.
English: The overall safety profile was considered acceptable and comparable to other phosphate binders.
Maltese: Il-profil globali tas-sigurtà kien ikkunsidrat aċċetabbli u komparabbli ma' sustanzi oħra li jeħlu mal-fosfat.
English: The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals.
Maltese: Id-doża tal-bidu rakkomandata hija 3 sa 6 pilloli kuljum, li jittieħdu f'dożi diviżi flimkien mal-ikliet.
English: Fexeric must not be used in patients with low blood-phosphate levels, patients who have severe problems with the stomach and gut (such as bleeding from the gut), and those with iron accumulation disorders such as haemochromatosis.
Maltese: Fexeric ma għandux jintuża f'pazjenti b'livelli baxxi ta' fosfat fid-demm, f'pazjenti li għandhom problemi serji bl-istonku u l-musrana (bħal fsada mill-musrana), u f'dawk b'disturbi ta' akkumulazzjoni tal-ħadid bħal emokromatożi.
English: The CHMP considered that Fexeric is effective at controlling blood-phosphate levels in patients with long-term kidney disease, whether they are on dialysis or not.
Maltese: Fexeric intwera li huwa effikaċi fil-kontroll tal-livelli ta' fosfat fid-demm f'żewġ studji ewlenin f'pazjenti b'mard tal-kliewi fit-tul u iperfosfatemija.
English: A risk management plan has been developed to ensure that Fexeric is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Fexeric jintuża bl-aktar mod sigur possibbli.
English: Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl.
Maltese: Iż-żewġ studji eżaminaw it-tibdil fl-ammont ta' fosfat fiddemm, imkejjel f'mg/dl.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Fexeric huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: What benefits of Fexeric have been shown in studies?
Maltese: Għaliex ġiet approvat Fexeric?
English: The most common side effects with Fexeric (which may affect more than 1 in 10 people) are changes in bowel movements (diarrhoea or constipation) and discoloured faeces.
Maltese: L-effetti sekondarji l-aktar komuni b'Fexeric (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma tibdil fil-mod kif jaħdmu l-imsaren (dijarea jew stitikezza) u tibdil fil-kulur tar-rawt.
English: Fexeric was shown to be effective at controlling blood-phosphate levels in 2 main studies in patients with long-term kidney disease and hyperphosphataemia.
Maltese: Dan iwaqqaf il-fosfat milli jiġi assorbit fil-ġisem u jgħin biex iżomm il-livelli ta' fosfat fid-demm baxxi.
English: EMA/23705/2010 EMEA/H/C/1102
Maltese: EMEA/H/C/1102
English: 20 January 2009
Maltese: 20 ta' Jannar 2009
English: The application was withdrawn at ‘day 180'.
Maltese: L-applikazzjoni ġiet irtirata fil-‘jum 180'.
English: The active substance in Sliwens, eplivanserin, is a 5-hydroxytryptamine receptor antagonist.
Maltese: Is-sustanza attiva f'Sliwens, eplivanserin, hija ‘antagonista tar-riċettur tal-hydroxytryptamin-5'.
English: Sliwens is a medicine that contains the active substance eplivanserin.
Maltese: Sliwens huwa mediċina li fiha s-sustanza attiva eplivanserin.
English: It was to be available as tablets.
Maltese: Huwa disponibbli bħala pilloli.
English: There was also a lack of information comparing the long-term use of Sliwens with placebo.
Maltese: Kien hemm ukoll nuqqas ta' informazzjoni fit-tqabbil tal-użu fit-tul ta' Sliwens ma' placebo.
English: study involving 283 adults compared Sliwens with lormetazepam (another medicine used to treat insomnia) looked at how sleepy the patients were the morning after taking Sliwens.
Maltese: Studju ieħor, il-ħames wieħed, involva 283 adult u qabbel Sliwens ma' lormetazepam (mediċina oħra użata għall-kura tal-insonnja).
English: What is Sliwens?
Maltese: X'inhu Sliwens?
English: The studies compared Sliwens with placebo (a dummy treatment).
Maltese: Dawn l-istudji qabblu Sliwens ma' plaċebo (trattament finta).
English: It blocks receptors in the brain called 5-hydroxytryptamine type 2 receptors, which are involved in regulating the daily cycle of being asleep and being awake.
Maltese: Dan jimblokka r-riċetturi fil-moħħ imsejħa riċetturi hydroxytryptamine-5 tat-tip 2, li huma involuti firregolamentazzjoni taċ-ċiklu ta' kuljum li tkun rieqed u mqajjem.
English: On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.
Maltese: Fit-18 ta' Diċembru 2009, Sanofi-Aventis uffiċjalment infurmat lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bix-xewqa li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Sliwens, għall-użu f'adulti b'insonnja kronika (fit-tul) li għandhom diffikultà biex jibqgħu reqdin.
English: Withdrawal of marketing authorisation application for Sliwens (eplivanserin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Sliwens (eplivanserin)
English: A fifth
Maltese: Il-kejl
English: The company presented results of four main studies involving over 3,000 adults who had difficulty staying asleep.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' erba' studji ewlenin li involvew aktar minn 3,000 adult li kellhom diffikultà biex jibqgħu mqajmin.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija u fassal lista ta' mistoqsijiet.
English: Summary of the application at the time of withdrawal
Maltese: Sommarju tal-applikazzjoni fiż-żmien l-irtirar
English: What was Sliwens expected to be used for?
Maltese: Kif kien mistenni li jaħdem Sliwens?
English: The effects of Sliwens were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Sliwens ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: The CHMP considered the effect of Sliwens on sleep to be small.
Maltese: Għal xiex kien mistenni li jintuża Sliwens?
English: Sliwens was expected to be used in adults with long-term insomnia (difficulty sleeping).
Maltese: Sliwens kien mistenni jintuża f'adulti li jbatu minn insonnja fit-tul (diffikultà biex torqod).
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 Sliwens could not have been approved.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiżżmien tal-irtirar, is-CHMP wera xi tħassib u kellu l-opinjoni proviżorja li Sliwens ma setax jiġi approvat.
English: Budapest H-1138 Hungary
Maltese: Budapest H-1138
English: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti,
Maltese: B-dul Theodor Pallady nr. 50, sector 3,
English: Baxter Hungary Kft Népfürdő u. 22.
Maltese: L-Ungerija Baxter Hungary Kft Népfürdő u. 22.
English: Leskoškova cesta 9D 1000 Ljubljana Slovenia
Maltese: Leskoškova cesta 9D 1000 Ljubljana
English: Strada Fânarului nr. 2A, 500464 Braşov, Romania
Maltese: Strada Fânarului nr. 2A, 500464 Braşov,
English: Box 35, Taxiarhes, Trikala,
Maltese: P.O. Box 35, Taxiarhes, Trikala,
English: Belgium Baxter SA Bd Rene Branquart, 80 7860 Lessines Belgium
Maltese: Il-Belġju Baxter SA Bd Rene Branquart, 80 7860 Lessines Belgium
English: Fresenius Kabi Norge AS Postboks 430
Maltese: In-Norveġja Fresenius Kabi Norge AS Postboks 430
English: 1753 Halden Norway
Maltese: 1753 Halden
English: Baxter Deutschland GmbH, Edissonstrasse 4+Unterschleissheim,
Maltese: Il-Bulgarija Baxter Deutschland GmbH, Edissonstrasse 4+Unterschleissheim,
English: Medias International d.o.o.
Maltese: Is-Slovenja Medias International d.o.o.
English: Fresenius Kabi EOOD "Alexander Jendov" str.
Maltese: Il-Bulgarija Fresenius Kabi EOOD "Alexander Jendov" str.
English: B. Braun Adria d.o.o Hondlova 2/9
Maltese: Il-Kroazja B. Braun Adria d.o.o Hondlova 2/9
English: Serumwerk Bernburg AG
Maltese: Il-Ġermanja Serumwerk Bernburg AG
English: Tammasaarenkatu 1 P.O.Box 119
Maltese: Il-Finlandja Baxter Oy Tammasaarenkatu 1 P.O.Box 119
English: Baxter S.p.A. Piazzale dell industria,
Maltese: Piazzale dell industria,
English: Belgium Fresenius Kabi NV Molenberglei 7
Maltese: Il-Belġju Fresenius Kabi NV Molenberglei 7
English: Crown Tower ul.Hrubieszowska 2 Warszawa
Maltese: Crown Tower ul.Hrubieszowska 2
English: 105b 06406 Bernburg Germany
Maltese: Hallesche Landstr. 105b 06406 Bernburg
English: S.C. INFOMED FLUIDS S.R.L.,
Maltese: INFOMED FLUIDS S.R.L.,
English: Kruczkowskiego 8 00-380 Warszawa Poland
Maltese: 00-380 Warszawa
English: Kennedya 6b 10000 Zagreb Croatia
Maltese: Kennedya 6b 10000
English: Luxembourg Baxter S.A. Boulevard René Branquart 80
Maltese: Boulevard René Branquart 80
English: S.C. INFOMED FLUIDS S.R.L.
Maltese: INFOMED FLUIDS S.R.L.
English: Baxter Deutschland GmbH
Maltese: Il-Ġermanja Baxter Deutschland GmbH
English: IP24 3SE United Kingdom
Maltese: 3SE United Kingdom
English: Baxter Healthcare GmbH
Maltese: L-Awstrija Baxter Healthcare GmbH
English: S.C. FRESENIUS KABI ROMÂNIA S.R.L.
Maltese: FRESENIUS KABI ROMÂNIA S.R.L.
English: Fresenius Kabi Austria GmbH
Maltese: L-Awstrija Fresenius Kabi Austria GmbH
English: Baxter Polska Sp. z o.o.
Maltese: Il-Polonja Baxter Polska Sp. z o.o. ul.
English: 34212 Melsungen Germany
Maltese: D-34212 Melsungen Germany
English: 10000 Zagreb Croatia
Maltese: 1000 Ljubljana Slovenija
English: Baxter Healthcare Limited,
Maltese: Ir-Renju Unit Baxter Healthcare Limited,
English: FRESENIUS KABI ITALIA Srl
Maltese: FRESENIUS KABI ITALIA
English: Box 1110 +1120 DE-34209 Melsungen Germany
Maltese: B. Braun Melsungen AG P.O. Box 1110 +1120 DE-34209 Melsungen Germany
English: 75174 Uppsala, Sweden
Maltese: 75174 Uppsala,
English: Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) Spain
Maltese: Pouet de Camilo, 2 46394
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Maltese: Il-Polonja Berlin-Chemie AG Glienicker Weg 125
English: UAB “BERLIN CHEMIE MENARINI BALTIC” Jasinskio 16a, LT-01112 Vilnius, Lithuania
Maltese: Il-Litwanja UAB “BERLIN CHEMIE MENARINI BALTIC”
English: S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania
Maltese: Ir-Rumanija S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A,
English: D-34212 Melsungen
Maltese: 34212 Melsungen
English: Baxter AS Gjerdumsvei 11 0484 Oslo Norway
Maltese: In-Norveġja Baxter AS Gjerdumsvei 11
English: Fresenius Kabi Polska Sp. z o.o.
Maltese: Il-Polonja Fresenius Kabi Polska Sp. z o.o.
English: Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H
Maltese: Il-Polonja Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H
English: B. BRAUN MELSUNGEN AG,
Maltese: Ir-Rumanija B. BRAUN MELSUNGEN AG,
English: Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1
Maltese: Il-Finlandja B. Braun Melsungen AG Carl-Braun-Strasse 1
English: Str.1, D34212 Melsungen, Germany
Maltese: Str.1, D34212 Melsungen,
English: Fresenius Kabi Polska Sp.z o.o
Maltese: L-Estonja Fresenius Kabi Polska Sp.z o.o
English: B. Braun Melsungen AG Carl-Braun-Str. 1
Maltese: Il-Belġju B. Braun Melsungen AG Carl-Braun-Strasse 1
English: Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1
Maltese: In-Norveġja B. Braun Melsungen AG Carl-Braun-Straße 1
English: 0.450.55 AV. MW 200K, sodium chloride
Maltese: MW 200K, sodium chloride
English: B.Braun Melsungen AG Carl-Braun-Strasse 1 D-34212 Melsungen Germany
Maltese: B.Braun Melsungen A.G. Carl-Braun-Straße 1 D-34212 Melsungen Germany
English: Hallesche Landstr.
Maltese: Manor Park
English: In Plegridy,
Maltese: Fi Plegridy,
English: Further information on Plegridy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/plegridy.
Maltese: Aktar informazzjoni dwar Plegridy tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/plegridy.
English: This overview was last updated in 11-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'11-2019.
English: Plegridy contains the active substance peginterferon beta-1a.
Maltese: Plegridy fih is-sustanza attiva peginterferon beta-1a.
English: Other information about Plegridy
Maltese: Informazzjoni oħra dwar Plegridy
English: Plegridy is available as a solution for injection in pre-filled pens or pre-filled syringes that contain 63, 94 or 125 micrograms peginterferon beta-1a.
Maltese: Plegridy jiġi bħala soluzzjoni għall-injezzjoni f'pinen mimlija lesta jew siringi mimlija lesta li fihom 63, 94 jew 125 mikrogramma peginterferon beta-1a.
English: Plegridy received a marketing authorisation valid throughout the EU on 18 July 2014.
Maltese: Plegridy irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Lulju 2014.
English: The most common side effects with Plegridy (which may affect more than 1 in 10 people) are headache, muscle pain, joint pain, influenza (flu)-like symptoms, pyrexia (fever), chills, asthenia (weakness), and erythema (reddening of the skin), pain or pruritus (itching) at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni bi Plegridy (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, uġigħ fil-muskoli, uġigħ fil-ġogi, sintomi li jixbhu lill-influwenza, piressija (deni), sirda, astenija (dgħufija), u eritema (ħmura tal-ġilda), uġigħ jew prurite (ħakk) fis-sit tal-injezzjoni.
English: The active substance in Plegridy is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Maltese: Is-sustanza attiva fi Plegridy hija l-proteina interferon beta-1a, wieħed minn grupp ta' interferoni li jista' jiġi prodott b'mod naturali mill-ġisem biex jgħinu jiġġieled il-viruses u attakki oħra.