FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are taking any other medicine that is known to be affected by iron (for example medicines containing the active substance alendronate (used to treat certain bone disorders) or doxycycline (an antibiotic)) or has the potential to be affected by iron (for example medicines containing the active substance levothyroxine (used to treat thyroid function disorder)), make sure that you take this medicine at least one hour before taking Velphoro or at least two hours after taking Velphoro.
Maltese: Jekk qed tieħu kwalunkwe mediċina oħra li hi magħrufa li tiġi affettwata mill-ħadid (pereżempju mediċini li fihom is-sustanza attiva alendronate (użata fit-trattament ta' ċerti disturbi fl-għadam) jew doxycycline (antibijotiku)) jew li għandha l-potenzjal li tiġi affettwata mill-ħadid (pereżempju mediċini li fihom is-sustanza attiva levothyroxine (użata fit-trattament ta' disturb fil-funzjoni tattirojde)), aċċerta ruħek li tieħu din il-mediċina mill-inqas siegħa qabel ma tieħu Velphoro jew millinqas sagħtejn wara li tieħu Velphoro.
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola li tomgħodhom
English: Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table 1.
Maltese: Reazzjonijiet avversi li ġew irrappurtati mill-użu ta' Velphoro f'dożi minn 250 mg ta' ħadid/jum sa 3,000 mg ta' ħadid/jum f'dawn il­pazjenti (n=835) huma elenkati f'Tabella 1.
English: Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro.
Maltese: Pazjenti bi storja medika riċenti ta' peritonite (fl­aħħar 3 xhur), ta' disturbi sinifikanti gastriċi u epatiċi, u pazjenti li jkunu għamlu operazzjoni gastrointestinali maġġuri, ma ġewx inklużi fl­istudji kliniċi b'Velphoro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
Maltese: NUMRU(I) TAL­AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/943/001 30 pillola li tomgħodhom
English: This study was an open-label, randomised, activecontrolled (sevelamer carbonate), parallel group study for up to 55 weeks.
Maltese: Dan l­istudju kien studju open-label, li fih il­parteċipanti ntgħażlu b'mod każwali, ikkontrollat b'mod attiv (sevelamar carbonate), u grupp parallel, li dam sa 55 ġimgħa.
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallfructose,malassorbiment tal-glucose-galactose jew nuqqas ta'sucrase-isomaltase, m'għandhomx jieħdu din il­mediċina.
English: Since absorption of iron from Velphoro is minimal (see section 5.2), excretion of iron from Velphoro in breast milk is unlikely.
Maltese: Billi l­assorbiment ta' ħadid minn Velphoro hu minimu (ara sezzjoni 5.2), it­tneħħija tal-ħadid minn Velphoro fil-ħalib tas-sider hi improbabbli.
English: LIST OF EXCIPIENTS Contains sucrose, potato starch and pregelatinised maize starch.
Maltese: Fih is­sucrose, starch tal-patata u starch tal-qamħirrun ġelatinizzat minn qabel.
English: In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.
Maltese: Fl­istudji fit-tul li damu 55 ġimgħa, il­maġġoranza ta' dawn ir-reazzjonijiet avversi ta' dijarea kienu temporanji, seħħew kmieni filbidu tal-kura u wasslu għat-twaqqif tal-kura fi 3.1% tal-pazjenti.
English: Multipacks are available for the blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each).
Maltese: Pakketti multipli huma disponibbli għall-pakketti bil-folji b'90 pillola li tomgħodhom (pakkett multiplu li fih 3 pakketti individwali ta' 30 × 1 pillola li tomgħodhom kull wieħed).
English: In animal studies, there were no adverse effects on mating performance, fertility, and litter parameters following treatment with Velphoro (see section 5.3).
Maltese: Fi studji dwar l­annimali, ma kien hemm ebda effetti avversi fuq il­prestazzjoni tat-tgħammir, fertilità, u l­parametri tal-frieħ wara l­kura b'Velphoro (ara sezzjoni 5.3).
English: Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.
Maltese: Velphoro fih is­sucrose u starches (karboidrati)
English: Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin).
Maltese: Dejta minn studji kliniċi wriet li Velphoro ma jaffettwax l­effetti tat-tnaqqis tal-lipidi tal-inibituri ta' HMG-CoA reductase (eż. atorvastatin u simvastatin).
English: Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Maltese: Il­livelli ta' phosphorous fis-serum jitnaqqsu bħala konsegwenza tat-tnaqqis fl­assorbiment talphosphate dijetiku.
English: In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 - 2,000 mg iron per day (3 to 4 tablets).
Maltese: Fil-prattika klinika, il­kura se tiġi bbażata fuq il­bżonn li jkunu kkontrollati l­livelli ta' phosphorous fis-serum, għalkemm il­pazjenti li jirrispondu għat-terapija b'Velphoro ġeneralment jiksbu livelli ottimali ta' phosphorous fis-serum b'dożi ta' 1,500 - 2,000 mg ta' ħadid kuljum (3 jew 4 pilloli).
English: Patients with diabetes should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Maltese: Pazjenti bid-dijabete għandhom jiġi avżati li pillola waħda ta' Velphoro hi ekwivalenti għal madwar 1.4 g ta' karboidrati (ekwivalenti għal 0.116 unitajiet ta' ħobż).
English: Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.
Maltese: Kwalunkwe każijiet ta' doża eċċessiva ta' Velphoro (eż. ipofosfatemija) għandhom jiġu kkurati minn prattika klinika standard.
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets
Maltese: TAL-PRODOTT MEDIĊINALI Velphoro 500 mg pilloli li tomgħodhom.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s­sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The distribution studies in humans were not performed.
Maltese: L­istudji dwar id­distribuzzjoni fil-bnedmin ma twettqux.
English: Brown, circular tablets embossed with PA500 on one side.
Maltese: Pilloli kannella, tondi, imnaqqxa b'PA500 fuq naħa waħda.
English: • Haemochromatosis and any other iron accumulation disorders.
Maltese: • Emokromatożi u kwalunkwe disturbi oħra ta' akkumulazzjoni tal-ħadid.
English: In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose dependent effects were observed in healthy volunteers.
Maltese: F'2 studji ta' Fażi 1, ġie konkluż li l­potenzjal għal eċċess ta' ħadid hu minimu u ma ġew osservati l­ebda effetti li jiddependu fuq id­doża f'voluntiera b'saħħithom.
English: Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches.
Maltese: Velphoro hu mediċina li fiha s­sustanza attiva sucroferric oxyhydroxide li hi magħmula mill-ħadid, zokkor (sucrose) u starches.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX)
Maltese: FOLJI TA' 6 PILLOLI LI TOMGĦODHOM), PARTI MINN PAKKETT MULTIPLU (MINGĦAJR IL­KAXXA BLU)
English: At the end of week 24, 93 patients on hemodialysis whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks.
Maltese: Fl­aħħar ta' ġimgħa 24, 93 pazjent fuq l­emodijalisi li l­livelli tagħhom tal-phosphorus fis-serum kienu kkontrollati (<1.78 mmol/L) b'Velphoro fl­ewwel parti tal-istudju, intgħażlu mill-ġdid b'mod każwali biex ikomplu l­kura jew biddoża ta' manteniment tagħhom wara 24 ġimgħa (N=44 jew doża baxxa mhux effettiva ta' kontroll 250 mg ta' ħadid/jum, N=49) ta' Velphoro għal 3 ġimgħat addizzjonali.
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 agreed subsequent updates of the RMP.
Maltese: L­MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Maltese: Id­doża tas-soltu tal-bidu rakkomandata hi hi l-ekwivalenti ta' 1,500 mg ta' ħadid kuljum (3 pilloli).
English: Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Maltese: Ħadid bħala sucroferric oxyhydroxide
English: - When taking Velphoro you should adhere to your recommended diet and treatments prescribed by your doctor such as calcium supplements, vitamin D3 or calcimimetics.
Maltese: - Meta tkun qed tieħu Velphoro għandek issegwi d-dieta u t-trattamenti rakkomandati li ppreskrivilek it-tabib tiegħek bħal supplimenti tal-kalċju, vitamina D3 jew kalċimimetiċi.
English: If you have diabetes you should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Maltese: Jekk għandek id-dijabete, għandek tiġi avżat li pillola waħda ta' Velphoro hi ekwivalenti għal madwar 1.4 g ta' karboidrati (ekwivalenti għal 0.116 unitajiet ta' ħobż).
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
Maltese: 100-101 Terrasse Boieldieu Tour Franklin La
English: Concomitant administration of Velphoro did not affect the bioavailability of these medicinal products as measured by the area under the curve (AUC).
Maltese: L­għoti fl­istess ħin ta' Velphoro ma affettwax il­bijodisponibilità ta' dawn il­prodotti mediċinali kif imkejjel mill-erja taħt il­kurva (AUC).
English: However, the degradation product of Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)oxyhydroxide and be absorbed.
Maltese: Madankollu, il­prodott ta' degradazzjoni ta' Velphoro, l­ispeċi ta' ħadid mononukleari, jista' jintreħa mill-wiċċ ta' polynuclear iron(III)­oxyhydroxide u jiġi assorbit.
English: (listed in section 6) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron.
Maltese: (imniżżla fis-sezzjoni 6) - jekk għandek storja medika ta' akkumulazzjoni mhux normali ta' ħadid fl­organi tiegħek
English: Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Maltese: Velphoro għandu jintuża fil-kuntest ta' approċċ terapewtiku multiplu, li jista' jinkludi suppliment talcalcium, 1,25­dihydroxy Vitamin D3 jew wieħed mill-analogi tagħha, jew kalċimimetiċi biex jikkontrollaw l­iżvilupp ta' mard tal-kliewi fl­għadam.
English: Package leaflet: Information for the patient Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Maltese: Kull pillola li tomgħodha fiha 500 mg ta' ħadid bħala sucroferric oxyhydroxide.
English: Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration
Maltese: Il­professjonisti tal­kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia (see section 4.2 for information on paediatric use).
Maltese: L­Aġenzija Ewropea għall-Mediċini ddiferiet l­obbligu li jiġu ppreżentati riżultati tal-istudji b'Velphoro f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' iperfosfataemija (ara sezzjoni 4.2 għal informazzjoni dwar l­użu pedjatriku).
English: Only for the blister packs: - Separate the blister pack at perforations.
Maltese: Għall-pakketti bil-folji biss: - Issepara l­pakkett tal-folji fil-perforazzjonijiet.
English: Common (may affect up to 1 in 10 people): feeling sick (nausea), constipation, vomiting, indigestion, pain in stomach and gut, gas, tooth discolouration, change in taste.
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): tħossok imdardar (dardir), stitikezza, rimettar, indiġestjoni, uġigħ fl­istonku u fl­imsaren, gass, tibdil fil-kulur tas-snien, tibdil fit-togħma.
English: The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed.
Maltese: Il­parti attiva ta' Velphoro, pn­FeOOH, hi prattikament insolubbli u għalhekk ma tiġix assorbita.
English: Chewable tablet.
Maltese: - Żomm dan il­fuljett.
English: The majority of the adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported adverse reactions being diarrhoea and discoloured faeces (very common).
Maltese: Il-maġġoranza tarreazzjonijiet avversi rrappurtati mill-provi kienu disturbi gastrointestinali, bl-iktar reazzjoni avversi li ġew irrappurtati b'mod frekwenti jkunu dijarea u tibdil fil-kulur tal-ippurgar (komuni ħafna).
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANCE
Maltese: Défense 8 92042 Paris la Défense Cedex Franza
English: BATCH NUMBER Lot:
Maltese: Kodiċi ATC:
English: Clinical studies have demonstrated that the systemic absorption of iron from Velphoro is low.
Maltese: Studji kliniċi wrew li l­assorbiment sistemiku ta' ħadid minn Velphoro hu baxx.
English: Discoloured (black) stool may visually mask gastrointestinal bleeding (see section 4.5).
Maltese: Tibdil fil-kulur talippurgar/ippurgar iswed jista' viżwalment jaħbi ħruġ ta' demm gastrointestinali (ara sezzjoni 4.5).
English: Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2 - 4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
Maltese: Il­livelli ta' phosphorous fis-serum għandhom ikunu mmonitorjati u d­doża ta' Velphoro ttritrata ‘l fuq jew ‘l isfel f'inkrementi ta' 500 mg ta' ħadid (pillola waħda) kuljum kull 2 - 4 ġimgħat sakemm jintlaħaq livell aċċettabbli ta' phosphorous fis-serum, b'monitoraġġ kontinwu wara dan.
English: The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Maltese: Id­doża rakkomandata tal-bidu ta' Velphoro hija ta' 1,500 mg ta' ħadid kuljum (3 pilloli), maqsuma mal-ikliet tal-jum.
English: Dyspnoea
Maltese: Treddigħ
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
Maltese: NUMRU(I) TAL­AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/943/003
English: However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
Maltese: Madankollu, l­ebda evidenza ta' indeboliment tal-fwied jew ta' alterazzjoni sinifikanti tal-enzimi talfwied ma ġew osservati fl­istudji kliniċi b'Velphoro.
English: Pack sizes of 30 or 90 chewable tablets.
Maltese: Daqsijiet tal-pakkett ta' 30 jew 90 pillola li tomgħodhom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
Maltese: NUMRU(I) TAL­AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/943/004
English: Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to help control the phosphorus level in their blood when it is too high (hyperphosphataemia).
Maltese: Velphoro hu indikat għall-kontroll tal-livelli ta' phosphorus fis-serum f'pazjenti CKD adulti li jkunu fuq HD jew PD. M'hemm l­ebda dejta klinika disponibbli dwar Velphoro f'pazjenti fi stadji iktar bikrija ta' indeboliment tal-kliewi.
English: One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the efficacy and safety of Velphoro in this population.
Maltese: Studju kliniku wieħed ta' fażi 3 twettaq f'pazjenti b'CKD li kienu fuq id­dijalisi biex tiġi investigata l­effikaċja u s­sigurtà ta' Velphoro f'din il­popolazzjoni.
English: Diarrhoea* Faeces discoloured
Maltese: Togħma anormali talprodott
English: There are no data on the effect of Velphoro on fertility in humans.
Maltese: M'hemmx dejta dwar l­effett ta' Velphoro fuq il­fertilità fil-bnedmin.
English: Description of selected adverse reactions *Diarrhoea
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula *Dijarea
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il­pakketti tad-daqsijiet kollha jkunu fis-suq.
English: There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Maltese: M'hemmx dejta klinika disponibbli mill-użu ta' sucroferric oxyhydroxide fuq tqaliet esposti filbniedem.
English: Skin and subcutaneous tissue disorders
Maltese: Gass Tibdil fil-kulur tas-snien
English: 27 April 2010
Maltese: 27 ta' April 2010
English: EMA/183104/2010 Veterinary Medicines
Maltese: EMA/183104/2010
English: The mutual recognition procedures (DE/V/0103/001/II/007, DE/V/0103/002/II/007 and DE/V/0103/004/II/007) started on 3 December
Maltese: IlProċeduri ta' Rikonoxximent Reċiproċi (DE/V/0103/001/II/007, DE/V/0103/002/II/007 u DE/V/0103/004/II/007) bdew fit-3 ta' Diċembru 2008.
English: Article 6(12) of Regulation (EC) No 1084/2003.
Maltese: Artikolu 6(12) tar-Regolament (KE) Nru 1084/2003.
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Maltese: Mediċini Veterinarji
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the reference Member State was Germany and the concerned Member States were Austria, Belgium, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal and Sweden.
Maltese: L-applikazzjoni ġiet sottomessa fil-qafas talArtikolu 6 tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003, fejn l-Istat Membru ta' Referenza kien il-Ġermanja u l-Istati Membri Kkonċernati kienu l-Awstrija, il-Belġju, id-Danimarka, il-Greċja, Spanja, il-Finlandja, l-Irlanda, l-Italja, il-Lussemburgu, l-Olanda, in-Norveġja, il-Portugall u l-Iżvezja.
English: Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products that contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Maltese: Vasotop P 0.625 mg, Vasotop P 1.25 mg u Vasotop P 2.5 mg pilloli huma prodotti mediċinali veterinarji li fihom l-ingredjent attiv ramipril f'konċentrazzjonijiet ta' 0.625 mg, 1.25 mg u 2.5 mg rispettivament.
English: The rapporteur and co-rapporteur appointed were Dr. R. Breathnach and Dr. M. Holzhauser-Alberti respectively.
Maltese: Ir-Rapporteur u l-Ko-Rapporteur maħturin kienu ttabib R. Breathnach u t-tabib M.
English: Ramipril is an angiotensin-converting enzyme (ACE) inhibitor.
Maltese: Ramipril huwa inibitur ta' enzim li jikkonverti l-angjotensini (ACE).
English: Opinion following an Article 6(12) referral for Vasotop P tablet for dogs EMA/183104/2010
Maltese: Opinjoni wara referenza skont l-Artikolu 6(12) għal Vasotop P pillola għall-klieb EMA/471371/2010
English: The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin) therapy.
Maltese: Fil-preżent, il-prodotti huma awtorizzati sabiex jintużaw fuq klieb għat-trattament ta' kollass konġestiv tal-qalb (klassifikazzjoni NYHA grad II, III u IV) minħabba mard tal-qalb valvulari deġenerattiv kroniku jew kardjomijopatija, bi jew mingħajr terapija dijuretika miżjuda (furosemide) jew terapija bi glycocide kardijaku (digoxin/methyldigoxin).
English: Oral explanations were given on 11 November
Maltese: Spjegazzjonijiet orali ngħataw fil-11 ta' Novembru 2009.
English: The final opinion was converted into a Decision by the European Commission on 27 April 2010.
Maltese: L-opinjoni finali nbidlet f'Deċiżjoni mill-Kummissjoni Ewropea fi 27 ta' April 2010.
English: Further to rapporteurs' assessment of the currently available data, the CVMP adopted on 8 December 2009 an opinion recommending that the variation application for the veterinary medicinal products Vasotop P 0.625 mg tablet for dogs, Vasotop P 1.25 mg tablet for dogs and Vasotop P 2.5 mg tablet for dogs and associated names does not satisfy the criteria for approval in respect of efficacy.
Maltese: Wara valutazzjoni mir-rapporteurs tad-dejta disponibbli fil-preżent, is-CVMP adotta, fit-8 ta' Diċembru 2009, opinjoni li tirrakkomanda li l-applikazzjoni tal-varjazzjoni għall-prodotti mediċinali veterinarji Vasotop P 0.625 mg, pillola għall-klieb, Vasotop P 1.25 mg, pillola għall-klieb u Vasotop P 2.5 mg, pillola għall-klieb u l-ismijiet assoċjati, ma tissodisfax il-kriterji għall-approvazzjoni fir-rigward taleffikaċja.
English: On 2 July 2009 Belgium referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns whether the marketing authorisation should be varied by adding cats as a new target species by considering if a placebo group is deemed necessary in a clinical field trial to assess the efficacy of ramipril in cats to reduce systolic blood pressure.
Maltese: Fit-2 ta' Lulju 2009, il-Belġju rrefera l-kwistjoni lill-Aġenzija skont l-Artikolu 39 tad-Direttiva 2001/82/KE kif emendata bir-referenza għall-Artikolu 6(12) tar-Regolament (KE) Nru 1084/2003 minħabba tħassib fir-rigward ta' jekk l-awtorizzazzjoni għat-tqegħid fis-suq għandhiex tiġi varjata billi l-qtates jiżdiedu bħala speċi fil-mira ġdida billi jiġi kkunsidrat jekk grupp plaċebo jitqiesx neċessarju fi prova prattika klinika sabiex tiġi vvalutata l-effikaċja ta' ramipril fi qtates biex titnaqqas il-pressjoni tad-demm sistolika.
English: Opinion following an Article 6(12)
Maltese: Opinjoni wara referenza skont l-Artikolu 6(12) 1 għal
English: The marketing authorisation holder (Intervet International B.V.) submitted applications for a type II variation subject to mutual recognition procedures for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows: For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (Intervet International B.V.) issottometta applikazzjonijiet għal varjazzjoni tat-Tip II soġġett għal Proċeduri ta' Rikonoxximent Reċiproku għal Vasotop P 0.625 mg, Vasotop P 1.25 mg u Vasotop P 2.5 mg pilloli għall-klieb sabiex jinkludi indikazzjoni ġdida għall-qtates kif ġej: