FrancophonIA/ELRC3.0 huggingface dataset:
English: On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Maltese: Fit-23 ta' Novembru 2009, Antigenics Therapeutics Limited għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq għal Oncophage, maħsub bħala trattament addizzjonali wara intervent kirurġiku għal karċinoma lokalizzata taċ-ċelloli renali b'riskju għoli ta' rikorrenza.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Oncophage is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Oncophage jinsab hawnhekk.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Oncophage for use as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiż-żmien talirtirar, is-CHMP kien ta opinjoni negattiva, filwaqt li rrakkomanda li l-awtorizzazzjoni għat-tqegħid fissuq għal Oncophage għall-użu bħala trattament addizzjonali wara intervent kirurġiku għal karċinoma lokalizzat taċ-ċelloli renali b'riskju għoli ta' rikorrenza tiġi rrifjutata.
English: How was Oncophage expected to work?
Maltese: Għalxiex kien mistenni li jintuża Oncophage?
English: The company presented results of a study involving 818 adults with localised renal cell carcinoma that had been surgically removed and who had a high risk of the cancer coming back.
Maltese: Il-kumpanija ppreżentat riżultati ta' studju li kien jinvolvi 818-il adult b'karċinoma lokalizzata taċ-ċelloli renali li kienet tneħħiet permezz ta' intervent kirurġiku u li kienu f'riskju għoli li l-kanċer jitfaċċalhom mill-ġdid.
English: The effects of Oncophage were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Oncophage għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour.
Maltese: Minħabba li l-proteini f'vitespen ikunu simili għall-proteini fuq iċ-ċelloli tal-kanċer, kien mistenni li s-sistema immunitarja tattakka wkoll liċ-ċelloli tal-kanċer, biex b'hekk tipprevjeni r-rikorrenza jew it-tifrix tat-tumur oriġinali.
English: The active substance in oncophage, vitespen, is made up of proteins (‘heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells.
Maltese: Is-sustanza attiva f'Oncophage, vitespen, hija magħmula minn proteini (‘heat shock protein-peptide complex-96') li jkunu ġew estratti miċ-ċelloli tal-kanċer tal-pazjent. Meta Oncophage jingħata lill-pazjent, is-sistema difensiva tal-ġisem (sistema immunitarja) titgħallem tagħraf il-proteini f'vitespen bħala barranin u tagħti bidu għal reazzjoni immunitarja.
English: The company informed the CHMP that there are no patients in the European Union currently receiving Oncophage as part of a clinical trial or a formal compassionate use or named patient programme.
Maltese: Il-Kumitat innota wkoll li lkumpanija ma kinitx ipprovdiet informazzjoni biżżejjed dwar il-kontenut tal-mediċina u dwar il-proċess ta' manifattura.
English: It was to be used when there is a high risk of the cancer coming back after the patient has had surgery to remove the tumour.
Maltese: Kellu jintuża meta jkun hemm riskju għoli ta' rikorrenza tal-kanċer wara li l-pazjent ikun sarlu intervent kirurġiku sabiex jitneħħa t-tumur.
English: Oncophage was expected to be used in patients with renal cell carcinoma (a type of kidney cancer) that had not yet spread to other parts of the body (localised).
Maltese: Oncophage kien mistenni li jintuża f'pazjenti b'karċinoma taċ-ċelloli renali (tip ta' kanċer tal-kliewi) li ma jkunx għadu infirex għal partijiet oħrajn tal-ġisem (lokalizzat).
English: Strength Pharmaceutical form
Maltese: Numru ta' l-EU Isem Qawwa Għamla farmaċewtika
English: Further information on Prolia 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: Prolia received a marketing authorisation valid throughout the EU on 26 May 2010.
Maltese: Prolia rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-26 ta' Mejju 2010.
English: The medicine contains the active substance denosumab.
Maltese: Il-mediċina fiha s-sustanza attiva denosumab.
English: Other information about Prolia
Maltese: Informazzjoni oħra dwar Prolia
English: Uncommon or rare cases of cellulitis (inflammation of deep skin tissue), hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone have been seen in patients taking Prolia.
Maltese: Każijiet mhux komuni jew rari ta' ċellulite (infjammazzjoni tat-tessut fil-fond fil-ġilda), ipokalċimija (kalċju baxx fid-demm), ipersensittività (allerġija), osteonekrożi tax-xedaq (ħsara fl-għadam tax-xedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew illaxkar tas-snien) u fratturi mhux tas-soltu fl-għadma tal-koxxa dehru filpazjenti li ħadu Prolia.
English: Osteoporosis in women
Maltese: Osteoporożi fin-nisa
English: Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Maltese: Prolia ntwera li huwa aktar effettiv minn risedronate (mediċina bisfosfonata) biex iżid id-densità talgħadam fi studju ewlieni wieħed li involva 795 adult ikkurati b'mediċini kortikosterojdi.
English: The active substance in Prolia, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL.
Maltese: Is-sustanza attiva fi Prolia, id-denosumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' struttura speċifika fil-ġisem imsejħa RANKL.
English: Prolia has been compared with placebo in one main study involving 242 men with osteoporosis.
Maltese: Prolia tqabbel ma' plaċebo fi studju ewlieni wieħed li involva 242 raġel bl-osteoporożi.
English: In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Maltese: Fil-pazjenti li kienu ġew ikkurati b'kortikosterojdi sa 3 xhur qabel l-istudju, id-densità tal-għadam fis-sinsla lumbari żdiedet bi 3.1 % wara sena ta' kura bi Prolia meta mqabbel ma' żieda ta' 0.8 % b'risedronate.
English: Osteoporosis in men
Maltese: Osteoporożi fl-irġiel
English: Prolia is available as a solution for injection in prefilled syringes, each containing 60 mg denosumab.
Maltese: Prolia jiġi bħala soluzzjoni għall-injezzjoni f'siringi mimlijin minn qabel, u kull waħda jkun fiha 60 mg denosumab.
English: Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Maltese: Prolia ntwera li huwa aktar effettiv minn plaċebo biex jikkura telf tal-għadam fi studju ewlieni wieħed li involva 1,468 raġel li rċevew kura għall-kanċer tal-prostata li kienu f'riskju miżjud ta' frattura.
English: What are the risks associated with Prolia?
Maltese: Kif jaħdem Prolia?
English: Prolia reduces the risk of fractures in the spine;
Maltese: Prolia jnaqqas ir-riskju ta' frattura tas-sinsla tad-dahar;
English: In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
Maltese: Fl-ewwel wieħed minn dawn l-istudji, 2 % tan-nisa li rċevew Prolia kellhom frattura ġdida fis-sinsla tad-dahar wara 3 snin ta' kura meta mqabbel ma' 7 % tan-nisa li rċevew plaċebo.
English: In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Maltese: Fl-irġiel li ħadu Prolia, id-densità tal-għadam żdiedet b'5.7 % wara sena ta' kura meta mqabbel ma' żieda ta' 0.9 % flirġiel li ħadu plaċebo.
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Maltese: RANKL hija involuta fl-attivazzjoni talosteoklasti, iċ-ċelloli fil-ġisem li huma involuti fit-tkissir tat-tessut tal-għadam.
English: Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
Maltese: Prolia ntwera li huwa aktar effettiv minn plaċebo (kura finta) biex inaqqas fratturi f'żewġ studji ewlenin li involvew total ta' aktar minn 8,000 mara bl-osteoporożi li kienu għaddew mill-menopawża.
English: In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Maltese: Filpazjenti li kienu ġew ikkurati b'kortikosterojdi għal aktar minn 3 xhur qabel l-istudju, id-densità talgħadam fis-sinsla lumbari żdiedet bi 3.6 % wara sena ta' kura bi Prolia meta mqabbel ma' żieda ta' 2.0 % b'risedronate.
English: As for all medicines, data on the use of Prolia are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Prolia hija ssorveljata kontinwament.
English: Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Maltese: Prolia jingħata darba kull 6 xhur bħala injezzjoni ta' 60 mg taħt il-ġilda fil-koxxa, fl-addome (fiż-żaqq) jew fin-naħa ta' wara tad-driegħ.
English: Bone loss in adults receiving long-term corticosteroid therapy
Maltese: Telf tal-għadam f'adulti li rċevew terapija kortikosterojde għal perjodu twil
English: Prolia must not be used in people with hypocalcaemia (low blood calcium levels).
Maltese: Prolia m'għandux jintuża f'persuni b'ipokalċimija (livelli baxxi ta' kalċju fid-demm).
English: • bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
Maltese: • telf tal-għadam f'adulti b'riskju miżjud ta' fratturi li jiġu kkurati għal perjodu twil b'mediċini kortikosterojdi li jingħataw mill-ħalq jew permezz ta' injezzjoni.
English: • osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones).
Maltese: • osteoporożi (marda li tagħmel l-għadam fraġli) f'nisa li jkunu għaddew mill-menopawża u fi rġiel li għandhom riskju miżjud ta' frattura (għadam miksur).
English: Bone loss in men receiving treatment for prostate cancer
Maltese: Telf tal-għadam fi rġiel li rċevew kura għall-kanċer tal-prostata
English: The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs, and bone, joint and muscle pain.
Maltese: L-effetti sekondarji l-aktar komuni bi Prolia (li dehru f'aktar minn pazjent 1 minn kull 10) huma uġigħ fid-dirgħajn jew fis-saqajn, u uġigħ fl-għadam, fil-ġogi u fil-muskoli.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Maltese: Aktar informazzjoni fuq Prolia tinstab fis-sit elettroniku tal-Aġenzija:
English: None
Maltese: Xejn
English: Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Maltese: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
English: Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Maltese: Zulvac BTV ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' April 2017.
English: Zulvac BTV (inactivated bluetongue vaccine containing either serotype 1, 4 or 8)1
Maltese: Zulvac BTV (tilqima inattivata kontra l-marda tal-ilsien blu li fiha s-serotip 1, 4 or 8)1
English: Zulvac BTV is a vaccine.
Maltese: Zulvac BTV huwa tilqima.
English: This summary was last updated in December 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Diċembru 2018.
English: The local reactions lasted up to 25 days.
Maltese: Ir-reazzjonijiet lokali damu sa 25 jum.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Maltese: It-tilqima fiha wkoll “aġġuvanti” (idrossidu tal-aluminju u Quil-A) li jtejbu r-rispons tas-sistema immunitarja.
English: The vaccine contains inactivated (killed) bluetongue virus.
Maltese: It-tilqima fiha l-virus inattivat (maqtul) tal-ilsien blu.
English: They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Maltese: Jista' jkun hemm ukoll noduli li jistgħu jinħassu taħt il-ġilda li jkunu sa 60 cm2 fid-daqs li jitnaqqsu biż-żmien iżda jistgħu jippersistu għal aktar minn 50 jum.
English: A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Maltese: Studju fil-laboratorju fuq il-ħrief imlaqqmin bis-serotip 4 wrew li t-tilqima tnaqqas il-livelli tas-serotip 4 fid-demm għal mill-inqas 12-il xahar filwaqt li studji bis-serotip 1 u 8 wrew nuqqas tas-serotipi rispettivi wara sena.
English: Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8.
Maltese: Zulvac BTV fih il-virus tal-ilsien blu ta' tip wieħed magħżul mis-serotipi 1, 4 u 8.
English: When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Maltese: BTV serotip 1, BTV serotip 4 u BTV serotip 8.
English: The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Maltese: L-effetti sekondarji l-aktar komuni b'Zulvac BTV fl-ifrat (li jistgħu jaffettwaw aktar minn annimal wieħed f'10 annimali) huma reazzjonijiet lokali fis-sit tal-injezzjoni u żieda għal perjodu qasir fit-temperatura tal-ġisem, sa 2.7˚C, matul il-jumejn wara t-tilqima.
English: Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Maltese: Zulvac BTV huwa tilqima li tintuża fin-nagħaġ u fl-ifrat biex tipproteġihom kontra l-marda tal-ilsien blu, infezzjoni kkawżata mill-virus tal-ilsien blu li jiġi trażmess mill-insetti dipteri.
English: The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Zulvac BTV fuq in-nagħaġ (li jistgħu jaffettwaw aktar minn annimal wieħed f'10 annimali) huma żieda għal perjodu qasir fit-temperatura tal-ġisem, sa 1.6˚C, matul il-jumejn wara t-tilqima u reazzjonijiet lokali fis-sit tal-injezzjoni.
English: Laboratory studies were conducted with the individual serotypes 1 and 8 in cattle which showed that protection starts 15 days after completion on the initial vaccination course of two injections for serotype 1 and 25 days after completion of the initial vaccination course for serotype 8.
Maltese: Saru studji fil-laboratorju bis-serotipi individwali 1 u 8 fl-ifrat li wrew li l-protezzjoni tinbeda 15-il jum wara li jitlesta l-ewwel kors ta' tilqim inizjali ta' żewġ injezzjonijiet għas-serotip 1 u 25 jum wara li jitlesta l- kors ta' tilqim inizjali għas-serotip 8.
English: Other information about Zulvac BTV?
Maltese: Aktar informazzjoni dwar Zulvac
English: In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk l-annimali jiġu esposti għall-virus tal-ilsien blu, is-sistema immunitarja tagħhom tkun kapaċi tipproduċi antikorpi aktar malajr.
English: Why is Zulvac BTV authorised in the EU?
Maltese: BTV huwa awtorizzat fl-UE?
English: The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Maltese: BTV fil-21 ta' Frar 2019.
English: Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype.
Maltese: Saru studji fil-laboratorju bis-serotipi individwali 1, 4 u 8 kif ukoll bil-kombinazzjoni ta' 1 u 8 fin-nagħaġ li wrew li l-protezzjoni tinbeda tliet ġimgħat wara li jitlesta l-kors inizjali ta' żewġ injezzjonijiet għal kull serotip.
English: Further laboratory studies showed protection lasts for one year for the respective serotypes.
Maltese: Studji ulterjuri fil-laboratorju wrew li l-protezzjoni ddum sena għas-serotipi rispettivi.
English: For cattle protection starts 15 days after the initial course of two injections for serotype 1 whilst protection starts 25 days after the initial course of two injections for serotype 8.
Maltese: Għall-ifrat il-protezzjoni tinbeda 15-il jum wara l-kors inizjali ta' żewġ injezzjonijiet għas-serotip 1 filwaqt li l-protezzjoni tinbeda 25 jum wara l-kors inizjali ta' żewġ injezzjonijiet għas-serotip 8.
English: 1 Previously known as Zulvac BTV Ovis.
Maltese: 1 Preċedentement magħruf bħala Zulvac
English: For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Maltese: Għal aktar informazzjoni dwar l-użu ta' Zulvac BTV, aqra l-fuljett ta' tagħrif jew ikkuntattja lill-veterinarju jew lill-ispiżjar tiegħek.
English: The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Maltese: BTV huma akbar mir-riskji tiegħu u rrakkomandat li jkun awtorizzat għall-użu fl-UE.
English: The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Maltese: L-ewwel injezzjoni tingħata lin-nagħaġ minn meta jkollhom 6 ġimgħat u lill-ifrat minn meta jkollhom 12-il ġimgħa; u t-tieni injezzjoni tingħata 3 ġimgħat wara.
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Maltese: It-tilqima tista' tipprevjeni l-preżenza tas-serotipi 1 jew 8 fid-demm u tnaqqas il-livelli tas-serotip 4.
English: Further laboratory studies showed protection lasts for one year for each serotype.
Maltese: Studji ulterjuri fil-laboratorju wrew li l-protezzjoni ddum sena għal kull serotip.
English: • the CHMP reviewed the available data submitted by the Applicant
Maltese: • is-CHMP analizza d-dejta disponibbli ppreżentata mill-Applikant
English: The marketing authorisation application for a generic simvastatin oral suspension to be marketed as Simvastatin Vale 20 mg/5 ml and 40 mg/5 ml and indicated in the treatment of hypercholesterolemia and cardiovascular disease prevention was supported by a single bioequivalence study comparing the 20 mg/5 ml oral suspension to the 20 mg immediate release tablet of the reference product.
Maltese: L-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal sospensjoni orali ġenerika simvastatin li għandha titqiegħed fis-suq bħala Simvastatin Vale 20 mg/5 ml u 40 mg/5 ml u indikat fil-kura ta' iperkolesterolemija u l-prevenzjoni ta' mard kardjovaskulari ġiet appoġġjata minn studju wieħed talbijoekwivalenza li qabbel is-sospensjoni orali ta' 20 mg/5 ml mal-pillola ta' rilaxx immedjat ta' 20 mg tal-prodott ta' referenza.
English: While the CHMP agreed that there was a deviation from the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), which states that for substances with linear pharmacokinetics, bioequivalence should in general be established with the highest strengths, it considered that this deviation should be considered in light of the available data and therefore assessed the Applicant dossier to determine the clinical relevance of the deviation.
Maltese: Filwaqt li s-CHMP qabel li kien hemm devjazzjoni mil-Linja Gwida tas-CHMP dwar l-Investigazzjoni talBijoekwivalenza (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), li tiddikjara li ġeneralment għas-sustanzi b'farmakokinetika lineari, il-bijoekwivalenza għandha tiġi stabbilita bl-ogħla qawwiet, huwa qies li din id-devjazzjoni għandha tiġi kkunsidrata fid-dawl tad-dejta disponibbli u għaldaqstant ivvaluta d-dossier tal-Applikant biex jiddetermina r-rilevanza klinika tad-devjazzjoni.
English: • the CHMP considered that the available data allowed extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength
Maltese: • is-CHMP qies li d-dejta disponibbli ppermettiet li ssir estrapolazzjoni tal-bijoekwivalenza murija mill-qawwa ta' 20 mg/5 ml għall-qawwa ta' 40 mg/5 ml
English: Overall, having considering the totality of the available evidence, the CHMP concluded that while a deviation from the current bioequivalence guideline is acknowledged, no potential serious risk to public health was identified, that extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength is possible and that both strengths of the proposed product can therefore be considered bioequivalent to the reference product.
Maltese: B'mod ġenerali, wara li kkunsidra t-totalità tal-evidenza għad-dispożizzjoni, is-CHMP ikkonkluda li filwaqt li jirrikonoxxi devjazzjoni mil-linja gwida attwali dwar il-bijoekwivalenza, ma nstab l-ebda riskju serju potenzjali għal saħħet il-pubbliku, li l-estrapolazzjoni tal-bijoekwivalenza murija mill-qawwa ta' 20 mg/5 ml għall-qawwa ta' 40 mg/5 ml hija possibbli u li għalhekk, iż-żewġ qawwiet tal-prodott propost jistgħu jitqiesu bijoekwivalenti għall-prodott ta' referenza.
English: The CHMP considered that the pharmacokinetics of simvastatin are fully linear across the therapeutic dose range, that simvastatin is well absorbed and that no significant differences in absorption between the proposed and the reference product could be identified.
Maltese: Is-CHMP qies li l-farmakokinetika ta' simvastatin hija kompletament lineari fi ħdan il-medda ta' dożi terapewtiċi, li simvastatin huwa assorbit sew u li ma setgħetx tiġi identifikata xi differenza importanti fl-assorbiment tal-prodott propost u dak ta' referenza.