FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of agitation, hypertonia, hypotonis, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja, ipotonja, rogħda, ħedla, skumdità respiratorja, jew disturb fit-tmigħ.
English: Metabolism and nutrition disorders Weight gain
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Żieda filpiż
English: In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Maltese: Fi studji kliniċi, l-inċidenza tal-marda ta' Parkinson u distonja f'pazjenti kkurati b' olanzapine kienet numerikament ogħla, imma statistikament mhux differenti b'mod sinifikattiv mill-plaċebo.
English: This medicine contains 0.75 mg aspartame in each 7.5 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 0.75 mg aspartame f'kull 7.5 mg pillola li tinħall fil-ħalq.
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information).
Maltese: Fertilità L-effetti fuq il-fertilità mhumiex magħrufa (ara sezzjoni 5.3 għal informazzjoni ta' qabel l-użu kliniku).
English: EU/1/07/415/001 (14 tablets) EU/1/07/415/002 (28 tablets) EU/1/07/415/003 (35 tablets) EU/1/07/415/004 (56 tablets) EU/1/07/415/005 (70 tablets)
Maltese: EU/1/07/415/001 (14-il pillola) EU/1/07/415/002 (28 pillola) EU/1/07/415/003 (35 pillola) EU/1/07/415/004 (56 pillola) EU/1/07/415/005 (70 pillola)
English: Zalasta 2.5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Maltese: Zalasta 2.5 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali.
English: Zalasta 5 mg orodispersible tablets EU/1/07/415/032-036
Maltese: Zalasta 5 mg pilloli li jinħallu fil-ħalq EU/1/07/415/032-036
English: This medicine contains 0.50 mg aspartame in each 5 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 0.50 mg aspartame f'kull 5 mg pillola li tinħall fil-ħalq.
English: Potential interactions affecting olanzapine
Maltese: Is-sustanza attiva hi olanzapine.
English: Neuroleptic malignant syndrome (see section 4.4) Discontinuation symptoms
Maltese: Sindromu Newrolettiku Malinn (ara sezzjoni 4
English: In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Maltese: F'pazjenti b'episodju manijaku jew imħallat ta' disturb bipolari, olanzapine wera effikaċja superjuri għallplaċebo u għal valproate semisodium (divalproex) fit-tnaqqis tas-sintomi manijaċi fuq perjodu ta' 3 ġimgħat.
English: Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister.
Maltese: Zalasta 2.5 mg pilloli: disponibbli f'kaxxi ta'14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Maltese: Zalasta 7.5 mg pilloli: disponibbli f'kaxxi ta'14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: Zalasta 10 mg tablets Each tablet contains 10 mg olanzapine.
Maltese: Zalasta 10 mg pilloli Kull pillola fiha 10 mg olanzapine.
English: Zalasta 20 mg tablets Each tablet contains 20 mg olanzapine.
Maltese: Zalasta 20 mg pilloli Kull pillola fiha 20 mg olanzapine.
English: Zalasta 10 mg orodispersible tablets EU/1/07/415/042-046
Maltese: Zalasta 10 mg pilloli li jinħallu fil-ħalq EU/1/07/415/042-046
English: Zalasta 15 mg tablets Each tablet contains 15 mg olanzapine.
Maltese: Zalasta 15 mg pilloli Kull pillola fiha 15 mg olanzapine.
English: Zalasta 2.5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Maltese: Zalasta 2.5 mg pilloli Pakkett ta' folji (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 jew 70 pillola f'kaxxa.
English: In patients with Parkinson's disease Zalasta may worsen the symptoms.
Maltese: F'pazjenti bil-marda ta' Parkinson Zalasta jista' jiggrava s-sintomi.
English: Zalasta 15 mg orodispersible tablets EU/1/07/415/047-051
Maltese: Zalasta 15 mg pilloli li jinħallu fil-ħalq EU/1/07/415/047-051
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Maltese: Fi studju tal-ko-terapija ta' pazjenti ttrattati bil-litju jew b'valproate għal minimu ta' ġimagħtejn, iż-żieda ta' 10 mg ta' olanzapine (ko-terapija bil-litju jew b'valproate) wasslet għal tnaqqis ikbar fissintomi tal-manija meta mqabbel mal-litju jew ma' valproate wara 6 ġimgħat.
English: This medicine contains 1.50 mg aspartame in each 15 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 1.50 mg aspartame f'kull 15 mg pillola li tinħall fil-ħalq.
English: The daily dose of Zalasta is between 5 mg and 20 mg.
Maltese: Iddoża ta' kuljum ta' Zalasta hija bejn 5 mg u 20 mg.
English: BLISTER FOR ZALASTA 15 mg TABLETS
Maltese: FOLJA GĦAL ZALASTA 15 mg PILLOLI
English: BLISTER FOR ZALASTA 5 mg TABLETS
Maltese: FOLJA GĦAL ZALASTA 5 mg PILLOLI
English: Zalasta 5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Maltese: Zalasta 5 mg pilloli Pakkett ta'folji (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 jew 70 pillola f'kaxxa.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Maltese: Olanzapine wera wkoll riżultati ta' l-effikaċja komparabbli għal haloperidol f'termini talproporzjon ta' pazjenti f'remissjoni sintomatika mill-manija għad-dipressjoni wara 6 ġimgħat u 12-il ġimgħa.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Maltese: Fi studji li damu sa tliet xhur fil-ġrieden u sa sena fil-firien u l-klieb, l-effetti predominanti kienu ddipressoni tas-sistema nervuża ċentrali, l-effetti antikolinerġiċi u, disturbi ematoloġiċi periferali.
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Maltese: Olanzapine hu indikat għat-trattament ta' l-iskiżofrenija.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Maltese: olanzapine (doża medja kuljum ta' 4.4 mg) jew it-tul ta' żmien tat-trattament.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56-< 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Maltese: Tibdil fil-livelli taz-zokkor waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥5.56-<7 mmol/l) għal għoljin (≥7m mol/l) kienu komuni ħafna.
English: Zalasta 5 mg tablets Each tablet contains 5 mg olanzapine.
Maltese: Zalasta 5 mg pilloli Kull pillola fiha 5 mg olanzapine.
English: Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Maltese: L-effetti riversibbli konsistenti ma' livell elevat ta' prolactin fil-firien kienu jinkludu tnaqqis fit-toqol ta' l-ovarji u ta' l-utru u tibdiliet morfoloġiċi fl-epitilju vaġinali u fil-glandoli tas-sider.
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża ta' olanzapine jekk ikun inbeda trattament b'inibitur tas-CYP 1A2.
English: In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Maltese: Fi studju tal-prevenzjoni tar-rikorrenza li dam 12-il xahar f'pazjenti b'episodji manijaċi li kellhom remissjoni fuq olanzapine u li mbagħad tqassmu b'mod każwali fil-grupp ta' olanzapine u ieħor talplaċebo, olanzapine wera superjorità statistikament sinjifikanti fuq il-plaċebo fuq il-punt finali primarju tar-rikorrenza bipolari.
English: CARTON FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS
Maltese: KARTUNA GĦAL ZALASTA 5 mg PILLOLI
English: Neutropenia
Maltese: Prijapiżmu
English: 14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
Maltese: 14-il pillola li jinħall fil-ħalq 28 pillola li tinħall fil-ħalq 35 pillola li tinħall fil-ħalq 56 pillola li tinħall fil-ħalq 70 pillola li tinħall fil-ħalq
English: Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 10.
Maltese: Zalasta 10 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali bl-iskrizzjoni 10.
English: Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Maltese: Zalasta 15 mg pilloli: disponibbli f'kaxxi ta'14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: Zalasta 15 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Maltese: Zalasta 15 mg pilloli Pakkett ta' folji (OPA/Al/PVC, Al-foil): 14, 28, 35, 56 jew 70 pillola f'kaxxa.
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Maltese: Ġiet żviluppata tolleranza għad-dipressjoni tas-sistema nervuża ċentrali.
English: Each tablet contains 5 mg olanzapine.
Maltese: Kull pillola fiha 5 mg olanzapine.
English: Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Maltese: Zalasta 5 mg pilloli: disponibbli f'kaxxi ta'14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Maltese: Epatite (inkluż mard tal-fwied tattip epatoċellulari, kolestatiku jew tat-tnejn flimkien)
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t-temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni talfrixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija tal-ġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section
Maltese: Disturbi fil-fwied u fil-marrara Żieda ta' aminotransferases talfwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet filbidu tal-kura (ara sezzjoni 4.4)
English: Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Maltese: Id-doża inizjali rrakkomandata għal olanzapine hi 10 mg kuljum.
English: Hypothermia
Maltese: Pankreatite
English: Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Maltese: Zalasta 15 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali bl-iskrizzjoni 15.
English: It may be harmful for patient with phenylketonuria (PKU).
Maltese: Jista' jikkaġuna ħsara lil pazjent b'phenylketonuria (PKU).
English: Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 5.
Maltese: Zalasta 5 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali bl-iskrizzjoni 5.
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3;
Maltese: Kien hemm aktar nies li jpejpu fost is-suġġetti b'ċirrożi (4/6; 67 %) milli fost is-suġġetti li ma kellhom ebda disfunzjoni epatika
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' >75 sena u d-demenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' trattament b'olanzapine.
English: Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Maltese: Interazzjonijiet potenzjali li jaffettwaw olanzapine Billi olanzapine jiġi metabolizzat bis-CYP1A2, sustanzi li speċifikament jinduċu jew jinibixxu dan lisoenzim jistgħu jaffettwaw il-farmakokinetika ta' olanzapine.
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Maltese: Is-sorveljanza terapewtika tal-livelli ta' valproate fil-plażma ma indikatx li hu meħtieġ aġġustament fiddoża ta' valproate wara l-introduzzjoni ta' olanzapine fl-istess ħin.
English: This medicine contains 2.00 mg aspartame in each 20 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 2.00 mg aspartame f'kull 20 mg pillola li tinħall fil-ħalq.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension.
Maltese: Tużax adrenalina, dopamina jew sustanzi oħra simpatomimetiċi b'attività betaagonistika bħax l-istimulazzjoni beta tista' tkompli tbaxxi l-pressjoni.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see also section 4.4).
Maltese: Doża inizjali iktar baxxa (5 mg kuljum) mhix indikata bħala rutina iżda għandha tkun ikkunsidrata għal dawk li jkollhom 65 sena jew iktar meta xi fatturi kliniċi jitolbu dan (ara wkoll sezzjoni 4.4).
English: Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Maltese: Ma ntweriex li l-farmakokinetika ta' olanzapine tiġi affettwata minn fluoxetine (inibitur tas-CYP2D6), dożi waħdanin ta' sustanzi kontra l-aċtu (aluminju, manjeżju) jew cimetidine.
English: Further information on Jivi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Jivi.
Maltese: ema.europa.eu/medicines/human/EPAR/Jivi.
English: Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) huma komuni b'Jivi (li jaffettwaw sa 1 minn kull 10) u jistgħu jinkludu nefħa, ħruq u tingiż fis-sit tal-injezzjoni, dehxiet ta' bard, fwawar, raxx bil-ħakk, uġigħ ta' ras, urtikarja, pressjoni tad-demm baxxa, letarġija, dardir u rimettar, nuqqas ta' sabar, taħbit mgħaġġel tal-qalb, tagħfis fis-sider u tħarħir.
English: Other information about Jivi
Maltese: Informazzjoni oħra dwar Jivi
English: Jivi contains the active substance damoctocog alfa pegol.
Maltese: Jivi fih is-sustanza attiva damoctocog alfa pegol.
English: In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries.
Maltese: Fit-tieni parti tal-istudju, 17-il pazjent irċevew Jiri biex jikkontrollaw il-fsada waqt 20 kirurġija maġġuri.
English: What are the risks associated with Jivi?
Maltese: X'inhuma r-riskji assoċjati ma' Jivi?
English: In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.
Maltese: Fit-tieni studju fuq 61 tifel u tifla li kellhom inqas minn 12-il sena, Jivi li ngħata bħala kura preventiva, naqqas in-numru ta' episodji ta' fsada għal madwar 3 episodji fis-sena.
English: The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Maltese: Il-kumpanija li tqiegħed Jivi fis-suq ser twettaq studju biex jiġu investigati l-effetti potenzjali talakkumulazzjoni ta' PEG fil-korojde pleksus tal-moħħ u f'organi oħra.
English: The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body's factor VIII.
Maltese: Is-sustanza attiva f'Jivi, id-damoctocog alfa pegol, taħdem bl-istess mod bħall-fattur VIII tal-ġisem.
English: In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year.
Maltese: Fi studju fuq 134 pazjent minn 12-il sena ‘l fuq, 114-il pazjent li ngħataw Jivi bħala kura preventiva kellhom madwar 2 episodji ta' fsada fis-sena.
English: As for all medicines, data on the use of Jivi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Jivi hija ssorveljata kontinwament.
English: However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Maltese: Madankollu, studji fillaboratorju juru li PEG, li hija parti mis-sustanza attiva f'Jivi, tista' takkumula fil-ġisem, inkluż fi struttura fil-moħħ imsejħa korojde pleksus, wara kura fit-tul.
English: Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control.
Maltese: Wara kura bi prodotti tal-fattur VIII, inkluż Jivi, ċerti pazjenti jistgħu jiżviluppaw inibituri (antikorpi) kontra l-fattur VIII, u dan jipprevjeni lill-mediċina milli taħdem b'mod effikaċi u jirriżulta f'telf talkontroll tal-fsada.
English: Part of the active substance is a substance called polyethylene glycol, ‘PEG', which is included to help the medicine remain in the body for longer and thereby prolong its action.
Maltese: Parti mis-sustanza attiva hija sustanza msejħa polietilenglikol, “PEG”, li hija inkluża biex tgħin lillmediċina tibqa' fil-ġisem għal aktar żmien u għaldaqstant ittawwal l-azzjoni tagħha.
English: Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.
Maltese: Minħabba li dan potenzjalment jista' jikkawża problemi speċjalment fi tfal taħt it-12-il sena, Jivi huwa approvat biss għall-użu fl-adulti u fi tfal minn 12-il sena ‘il fuq.
English: How does Jivi work?
Maltese: Kif jaħdem Jivi?
English: The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year.
Maltese: L-20 pazjent li ngħataw Jivi għall-kura tal-fsada meta seħħet kellhom madwar 23 episodju ta' fsada fis-sena.
English: Why is Jivi authorised in the EU?
Maltese: Għaliex Jivi huwa awtorizzat fl-UE?
English: Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Maltese: Jivi ma għandux jintuża f'pazjenti b'allerġija għall-proteini tal-ġrieden jew tal-ħemsters.
English: Jivi was rated good or excellent at stopping bleeding in all surgeries.
Maltese: Jivi ġie kklassifikat bħala tajjeb jew eċċellenti biex iwaqqaf il-fsada fil-kirurġiji kollha.
English: Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Maltese: L-istudji juru li Jivi huwa effettiv għall-prevenzjoni u l-kura tal-episodji ta' fsada f'pazjenti bl-emofilja A u s-sigurtà tiegħu hija komparabbli ma' dik ta' prodotti tal-fattur VIII oħrajn.
English: AstraZeneca Kft. H-1113 Budapest Bocskai út 134-146 Hungary
Maltese: H-1113 Budapest Bocskai út 134-146 Hungary
English: AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark
Maltese: AstraZeneca A/S Arne Jacobsens Allé 13 2300
English: SIMESA S.p.A Palazzo Galileo Via F. Sforza 20080 Basiglio (MI) Italy
Maltese: SIMESA S.p.A Palazzo Galileo Via F. Sforza 20080
English: Belgium NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium
Maltese: NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium
English: AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy
Maltese: AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080
English: Gartunavagen, S-151 85 Sodertalje, Sweden
Maltese: S-151 85 Sodertalje
English: 1 place Renault 92844 Rueil-Malmaison Cedex France
Maltese: Rueil-Malmaison Cedex France
English: Luxembourg NV AstraZeneca SA Rue Egide van Ophemstraat B-1180 Brussel
Maltese: NV AstraZeneca SA Rue Egide van Ophemstraat B-1180 Brussel Belgium
English: Radnička cesta 80 10 000 Zagreb Croatia
Maltese: AstraZeneca d.o.o. Radnička cesta 80 10 000
English: Theotokopoulou & Astronafton str 151 25 Maroussi
Maltese: Theotokopoulou & Astronafton str
English: AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom
Maltese: Capability Green Luton LU1 3LU United Kingdom
English: Netherlands AstraZeneca BV Louis Pasteurlaan 5
Maltese: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Maltese: AstraZeneca UK Limited 2 Kingdom Street London W2 6BD United Kingdom
English: Plendil 10mg Prolongedrelease, Film-coated Tablets
Maltese: Plendil 10mg Prolonged-release, Film-coated Tablets
English: Felodipin AstraZeneca
Maltese: Felodipin AstraZeneca 5 mg
English: Plendil 2.5mg Prolongedrelease, Film-coated Tablets
Maltese: Plendil 2.5mg Prolonged-release, Film-coated Tablets
English: PLENDIL ER 10 mg
Maltese: PLENDIL ER 10 mg 10 mg
English: Slovak Republic AstraZeneca AB S-151 85 Sodertalje Sweden
Maltese: Astra Zeneca AB Gartunavagen, S-151 85
English: Astra Zeneca AB
Maltese: Ir-Repubblika Slovakka AstraZeneca AB
English: C/Serrano Galvache 56
Maltese: C/Serrano Galvache 56 Edificio Roble 28033 Madrid Spain
English: Croatia
Maltese: Zagreb Croatia
English: Annex I List of the names, pharmaceutical form, strength of the medicinal product, route of administration, Marketing Authorisation Holders in the Member States
Maltese: mediċinali, mnejn jingħata, id-detenturi ta` l-awtorizzazzjoni għat tqegħid fis-suq fl-istati membri
English: Plendil 5 mg Retard
Maltese: PLENDIL 5 mg Retard 5 mg
English: PLENDIL 5 mg Retard
Maltese: Plendil 5 mg Retard 5 mg
English: AstraZeneca d.o.o.
Maltese: AstraZeneca Kft.
English: United Kingdom AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU
Maltese: AstraZeneca UK Ltd. 600
English: Edificio Roble
Maltese: Il-Kroazja
English: Manufacturer MolMed SpA 58 Via Olgettina
Maltese: Manifattur MolMed SpA 58 Via Olgettina
English: Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, the Netherlands
Maltese: Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, l-Olanda
English: Store at 15-30°C.
Maltese: Aħżen f'temperatura ta' 15-30°C.
English: Store at 15-30°C
Maltese: Aħżen f'temperatura ta' 15-30°C
English: CD34+ cells/kg:
Maltese: CD34+ ċelluli/kg:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta 'l-ewwel awtorizzazzjoni: 26 ta' Mejju 2016
English: Guillain-Barré syndrome
Maltese: Sindrome ta' GuillainBarré
English: This will take about 20 minutes
Maltese: Dan għandu jieħu madwar 20 minuta.
English: Milan Italy
Maltese: Milan L-Italja
English: Survival n
Maltese: Sopravivenza n