FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP agreed that the wording was not acceptable to be included in the harmonised text, since prevention of relapse is considered to be part of good clinical practise in the treatment of schizophrenia and as such not required to be clearly specified in the therapeutic indication section of the SmPC.
Maltese: Is-CHMP qabel li l-kliem ma kienx aċċettabbli li jiġi inkluż fit-test armonizzat, ġaladarba l-prevenzjoni ta' rikaduta titqies parti minn prattika klinika tajba fil-kura ta' skizofrenja u bħala tali mhijiex meħtieġa li tiġi speċifikata b'mod ċar fis-sezzjoni tal-indikazzjoni terapewtika tal-SmPC.
English: Due to the combination of the MRP/DCP and national granted MAs some divergent information has been identified in the product information (PI) for Seroquel and Seroquel XR.
Maltese: Minħabba l-kombinazzjoni tal-MRP/DCP u l-MAs mogħtija fuq livell nazzjonali, ġiet identifikata xi informazzjoni diverġenti fl-informazzjoni dwar il-prodott (PI) għal Seroquel u Seroquel XR. Għaldaqstant, dawn il-prodotti mediċinali kienu inklużi fil-lista ta' prodotti għall-armonizzazzjoni tal-PI, imfassla mis-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE.
English: Although there were no major divergences in the wording, a more concise text concerning cardiovascular to prevent redundancy was agreed aiming specific product information for the prescriber instead of common knowledge on symptoms and consequences of orthostatic hypotension.
Maltese: Għalkemm ma kien hemm ebda diverġenzi ewlenin fil-formulazzjoni, intlaħaq ftehim dwar test aktar konċiż li jikkonċerna l-kardjovaskulari biex tiġi evitata informazzjoni żejda, li jimmira informazzjoni speċifika dwar il-prodott għal min jikteb ir-riċetti minflok ta' għarfien komuni dwar is-sintomi u lkonsegwenzi ta' ipotensjoni ortostatika.
English: Ferring Magyarország Kft. Váci út 140.
Maltese: Magyarország Kft. Váci út 140.
English: SESTO FIORENTINO 50019 FIRENZE
Maltese: FIORENTINO 50019 FIRENZE
English: 169 27 Solna Sweden
Maltese: 169 27 Solna
English: 203 11 Malmö Sweden
Maltese: 203 11 Malmö
English: IS - Iceland Pfizer APS Lautrupvang 8
Maltese: IS - L-islanda Pfizer APS Lautrupvang 8
English: IS - Iceland Novo Nordisk AS Novo Allé
Maltese: IS - L-islanda Novo Nordisk AS Novo Allé
English: Ferring Läkemedel AB Box 4041
Maltese: SE - L-Isvezja Ferring Läkemedel AB Box 4041
English: FR - France LILLY France 13, rue Pagès
Maltese: FR - Franza LILLY France 13, rue Pagès
English: Pobřežní 394/12 186 00 Praha Czech Republic
Maltese: Pobřežní 394/12 186 00
English: Eli Lilly Sweden AB Box 721
Maltese: SE - L-Isvezja Eli Lilly Sweden AB Box 721
English: IS - Iceland Eli Lilly Danmark Nybrovej 110
Maltese: IS - L-islanda Eli Lilly Danmark Nybrovej 110
English: LV - Latvia Merck Serono S.p.A., Via Casilina 125, I-00176
Maltese: LV - Il-Latvja Merck Serono S.p.A., Via Casilina 125, I-00176
English: Ferring PortuguesaProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Maltese: Ferring Portuguesa - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
English: AT - Austria Eli Lilly GmbH Kölblgasse 8- 10
Maltese: AT - L-Awstrija Eli Lilly GmbH Kölblgasse 8- 10
English: AT - Austria Pfizer Corporation Austria Gesellschaft m.b.H.
Maltese: AT - L-Awstrija Pfizer Corporation Austria Gesellschaft m.b.H.
English: FI - Finland Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
Maltese: FI - Il-Finlandja Pfizer Oy, Tietokuja 4, 00330 Helsinki,
English: EL - Greece Merck A.E. Hellas Kifisias Avenue 41-45 (Building B)
Maltese: EL - Il-Greċja Merck A.E. Hellas Kifisias Avenue 4145 (Building B)
English: Eli Lilly Nederland BV Grootslag 1-5
Maltese: NL - L-Olanda Eli Lilly Nederland BV Grootslag 1-5
English: Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
Maltese: SI - Slovenja Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
English: CZ - Czech Republic
Maltese: Praha Czech Republic
English: N14 9TP
Maltese: N14 9TP United Kingdom
English: Merck Serono Europe Ltd 56 Marsh Wall London
Maltese: Merck Serono Europe Ltd 56
English: 11, Vienna Twin Tower Turm West 10.OG
Maltese: Vienna Twin Tower Turm
English: Ferring Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
Maltese: Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
English: Floridsdorfer Hauptstraße 1
Maltese: Hauptstraße 1
English: ES - Spain MERCK S.L.Maria de Molina, 40 28006 Madrid
Maltese: ES - Spanja MERCK S.L.Maria de Molina, 40
English: Brucknerstr.
Maltese: Wienerbergstr.
English: NOVO NORDISK PHARMA SA
Maltese: Novo Nordisk Pharma
English: de la Industria, 30 Alcobendas 28108 MADRID
Maltese: Alcobendas 28108
English: Quinta da FonteEdifício D. José - Piso 1, 2780-730 Paço d' Arcos, Portugal
Maltese: JoséPiso 1, 2780-730 Paço d' Arcos, Portugal
English: 3991 RA HOUTEN Nederland
Maltese: 3991 RA HOUTEN
English: D-64289 Darmstadt
Maltese: Alsfelder Str. 17 D-64289 Darmstadt
English: FI - Finland Merck Oy, Pihatörmä 1 C, 02240 Espoo, Finland
Maltese: FI - Il-Finlandja Merck Oy, Pihatörmä 1 C, 02240
English: MT - Malta Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Maltese: Pfizer Hellas S.A. 234, Messoghion Ave., Neo Psychiko 15451, Athens, Greece
English: Urbanización La Florida.
Maltese: Urbanización La
English: IT - Italy FERRING SpA VIA SENIGALLIA, 18/2
Maltese: IT - L-Italja FERRING SpA VIA SENIGALLIA,
English: FR - France FERRING SAS 7, rue Jean-Baptiste Clément
Maltese: FR - Franza FERRING SAS 7, rue Jean
English: 8mg (24 NE) /1,5ml parenteral use
Maltese: 8mg (24 NE) /1,5ml
English: IS - Iceland Merck AB SE-195 87 Stockholm Sweden
Maltese: SE - L-Isvezja E. Merck AB 195 87 Stockholm Sweden
English: LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna, Sweden
Maltese: LV - Il-Latvja Pfizer Health AB, Vetenskapsvagen 10,SE-191 90
English: ET - Estonia Merck Serono S.p.A.
Maltese: ET - L-Estonja Merck Serono S.p.A.
English: 3991 RA Houten Netherlands
Maltese: Grootslag 1-5 3991 RA Houten Netherlands
English: ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00 Praha 8, Czech Republic
Maltese: ČR, s.r.o., Pobřežní 12, 180 00
English: Rua Alexandre HerculanoEdifício 1, Piso 6, 2795-240 Linda-a-Velha, Portugal
Maltese: Rua Alexandre Herculano - Edifício 1, Piso 6, 2795-240
English: 28023 Madrid
Maltese: Florida. 28023
English: AT - Austria Novo Nordisk Pharma GmbH
Maltese: AT - L-Awstrija Novo Nordisk Pharma GmbH
English: ET - Estonia Ferring GmbH Wittland 11
Maltese: ET - L-Estonja Ferring GmbH Wittland 11
English: NLNetherlands
Maltese: Nederland
English: IT - Italy Merck Serono S.p.A.
Maltese: IT - L-Italja Merck Serono S.p.A.
English: FR - France NOVO NORDISK PHARMACEUTIQUE SAS Le Palatin
Maltese: FR - Franza NOVO NORDISK PHARMACEUTIQUE SAS
English: Ferring BV Polariavenue 132 2132JX HoofddorpNederland
Maltese: 2132JX HoofddorpNederland
English: BEBelgium
Maltese: Belgium
English: Elly Lilly Norge AS, Grensevien 99, 0663 Oslo, Norway
Maltese: Elly Lilly Norge AS, Grensevien 99,
English: ES - Spain FERRING, S.A.U Gobelas, 11.
Maltese: A.U Gobelas, 11.
English: IT - Italy Pfizer Italia S.r.l.
Maltese: IT - L-Italja Pfizer Italia S.r.l. Via Valbondione
English: ES - Spain LILLY, S.A. Avda.
Maltese: ES - Spanja LILLY, S.A. Avda. de la Industria, 30
English: EL - Greece NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia Paraskevi
Maltese: Agias Triadas 65, Agia Paraskevi
English: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L1855 Luxembourg, Luxembourg
Maltese: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue
English: Via Casilina, 125, Rome, 00176, Italy
Maltese: Serono S.p. A Via Casilina, 125, Rome, 00176, Italy
English: IE - Ireland Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Maltese: IE - L-Irlanda Ferring Ireland Ltd., United Drug House, Magna
English: ES - Spain PFIZER, S.A.Avda.
Maltese: ES - Spanja PFIZER, S.A.Avda. de Europa, 20 B.
English: 00176 Roma Italy
Maltese: 00188 Rome Italy
English: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie subcutaneous
Maltese: ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie
English: ET - Estonia Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
Maltese: ET - L-Estonja Pfizer Enterprises SARL Round-Point du Kirchberg
English: Lilly Deutschland GmbH Teichweg 3
Maltese: Lilly Deutschland GmbH
English: FERRING NV Hopmarkt 9 b3 9300 Aalst Belgium
Maltese: BE - Il-Belġju FERRING NV Hopmarkt 9 b3
English: 30 rue de Valmy 92800 Puteaux-France
Maltese: 30 rue de Valmy
English: Feltham, Middlesex TW14 8NX0
Maltese: Feltham, Middlesex, TW14 8NX, England
English: Pfizer Luxembourg SARL, 51 av. J.-F. Kennedy, 1855 Luxembourg
Maltese: J.F.Kennedy, L1855 Luxembourg, Luxembourg
English: BGBulgaria
Maltese: BG - IlBulgarija
English: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable subcutaneous
Maltese: SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable
English: Pfizer BV, Rivium Westlaan 142, 2909 LD CAPELLE A/D IJSSEL D - Nederland
Maltese: 2909 LD CAPELLE A/D IJSSEL D
English: Saizen click easy 8 mg 8 mg s.c.
Maltese: Saizen click easy 8 mg 8 mg
English: SAIZEN 8 mg, poudre et solvant pour solution injectable subcutaneous
Maltese: SAIZEN 8 mg, poudre et solvant pour solution injectable
English: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose subcutaneous
Maltese: ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose
English: Boulevard international 55 1070 Brussels Belgium
Maltese: Boulevard international 55
English: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Maltese: ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable
English: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable subcutaneous
Maltese: MAXOMAT 1,3 mg, poudre et solvant pour solution injectable
English: Novo Nordisk A/S Novo Allé
Maltese: SE - L-Isvezja Novo Nordisk A/S Novo Allé
English: Lilly-Portugal, Produtos Farmacêuticos, Lda.
Maltese: Lilly-Portugal, Produtos
English: 191 90 Sollentuna Sweden
Maltese: SE - L-Isvezja Pfizer AB 191 90 Sollentuna Sweden
English: Novo Nordisk Pharma GmbH
Maltese: Novo Nordisk Pharma GmbH Brucknerstr.
English: 94250 Gentilly- France
Maltese: Baptiste Clément 94250
English: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Maltese: SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable
English: AT - Austria Merck Gesellschaft mbH Zimbagasse 5
Maltese: AT - L-Awstrija Merck Gesellschaft mbH
English: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
Maltese: ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable
English: Merck Serono GmbH Alsfelder Str. 17
Maltese: Merck Serono GmbH
English: NONorway
Maltese: Riverside
English: Eli Lilly Holdings Limited, Lilly House Priestley Road Basingstoke Hampshire RG24 9NL, United Kingdom
Maltese: Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom
English: HUMATROPE 72 NE (24 mg) injekció patronban powder and solvent for injection
Maltese: HUMATROPE 72 NE (24 mg) injekció patronban
English: HUMATROPE 18 NE (6 mg) injekció patronban powder and solvent for injection
Maltese: HUMATROPE 18 NE (6 mg) injekció patronban
English: MT - Malta Serono Ltd Bedfont Cross, Stanwell Road
Maltese: IE - L-Irlanda Merck Serono Limited, Bedfont Cross, Stanwell
English: FR - France MERCK SANTE 37, rue Saint-Romain 69008 Lyon France
Maltese: FR - Franza MERCK SANTE 37, rue Saint
English: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Maltese: UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable
English: PFIZER SA Bld de la Plaine,17 1050 Brussels Belgium
Maltese: BE - Il-Belġju PFIZER SA Bld de la Plaine,17
English: ES - Spain NOVO NORDISK A/SNovo AlleBagsvaerdDK-2880
Maltese: ES - Spanja NOVO NORDISK A/SNovo
English: ELI LILLY BENELUX SA Rue de l'Etuve 52/1 1000 Brussels Belgium
Maltese: Rue de l'Etuve 52/1
English: Humatrope 24mg For Injection powder for injection subcutaneous use
Maltese: Humatrope 24mg For Injection
English: SAIZEN 3,33 mg, poudre et solvant pour solution injectable subcutaneous
Maltese: SAIZEN 3,33 mg, poudre et solvant pour solution injectable
English: HUMATROPE 36 NE (12 mg) injekció patronban powder and solvent for injection
Maltese: HUMATROPE 36 NE (12 mg) injekció patronban
English: Humatrope 12mg For Injection powder for injection subcutaneous use
Maltese: Humatrope 12mg For Injection
English: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Maltese: UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable
English: FI - Finland Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
Maltese: FI - Il-Finlandja Ferring Lääkkeet Oy, Piispansilta 11
English: IT - Italy NOVO NORDISK A/S Novo Allé DK-2880
Maltese: LT - Il-Litwanja Novo Nordisk A/S, Novo Allé DK-2880
English: FR - France PFIZER HOLDING France 23-25, avenue du Docteur Lannelongue
Maltese: FR - Franza PFIZER HOLDING France
English: SAIZEN 1,33 mg, poudre et solvant pour solution injectable subcutaneous
Maltese: SAIZEN 1,33 mg, poudre et solvant pour solution injectable
English: PL - Poland Industria Farmaceutica Serono S.p. A
Maltese: PL - Il-Polonja Industria Farmaceutica
English: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Maltese: UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable
English: CY - Cyprus NOVO NORDISK A/S, Novo Allé, DK-2880 BAGSVAERD, DENMARK
Maltese: CY - Ċipru NOVO NORDISK A/S, Novo Allé, DK2880 BAGSVAERD, DENMARK
English: HUMATROPE 24 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Maltese: HUMATROPE 24 mg polvo y disolvente para solución inyectable
English: LV - Latvia Ferring GmbH, Wittland 11, 24109 Kiel, Germany
Maltese: LV - Il-Latvja Ferring GmbH, Wittland 11, 24109
English: FI - Finland Eli Lilly Finland Oy Ab, Rajatorpantie 41 C, PL 16, 01641 Vantaa, Finland
Maltese: 41 C, PL 16, 01641
English: Subcutaneous
Maltese: Puteaux
English: EL - Greece FERRING HELLAS S.A. GKYZI 3, MAROUSI 15125
Maltese: EL - Il-Greċja Pfizer Hellas S.A. 234, Messoghion
English: HUMATROPE 6 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Maltese: HUMATROPE 6 mg polvo y disolvente para solución inyectable
English: Bocskai út 134-146.
Maltese: Merck Kft. Bocskai út 134
English: DKDenmark
Maltese: Lannelongue
English: SKSlovakia
Maltese: SK - IsSlovakkja
English: LTLithuania
Maltese: Ltd.
English: HUMATROPE 12 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Maltese: HUMATROPE 12 mg polvo y disolvente para solución inyectable
English: NovoNordis A/S, Novo Alle, Basvaerd, DK
Maltese: SI - Slovenja NovoNordis A/S, Novo Alle,
English: IE - Ireland Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Maltese: Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
English: EL - Greece Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Maltese: Ave., Neo Psychiko 15451, Athens,
English: AT - Austria Ferring Arzneimittel GmbH Wienerbergstr.
Maltese: AT - L-Awstrija Ferring Arzneimittel GmbH
English: Zomacton 4mg injection 4mg powder for solution for injection
Maltese: Zomacton 4mg injection 4mg
English: Norditropin NordiFlex 10 mg/1.5 mL Solution for injection, prefilled syringe
Maltese: Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in pre-filled pen
English: Flemingweg 18, 2408 AV ALPHEN A/D RIJN Nederland
Maltese: 2408 AV ALPHEN
English: Norditropin NordiFlex 5 mg/1,5 mlInjektionslösung in einem Fertigpen solution for injection, in pre-filled pen
Maltese: Norditropin NordiFlex 5 mg/1.5 ml, solution for injection, in pre-filled pen
English: Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd, Denmark
Maltese: NovoNordisk A/S Novo Alle, DK2880 Bagsvaerd, Denmark
English: Norditropin SimpleXx 10 mg / 1,5 mL solution for injection injection
Maltese: Norditropin SimpleXx 10 mg / 1.5 ml, solution for injection
English: Norditropin Nordiflex 5mg/1,5ml solution for injection subcutaneous
Maltese: NORDITROPIN NORDIFLEX 5 mg / 1.5 ml solución inyectable
English: Saizen 5.83 mg/ml Solution for Injection solution for injection Subcutanous injection
Maltese: Saizen 5.83 mg/ml Solution for Injection
English: Norditropin NordiFlex 15 mg/1.5 mL Solution for injection, prefilled syringe
Maltese: Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in pre-filled pen
English: List of the invented name(s), pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Maltese: Anness I Lista tal-isem(ijiet) ivvintat(i), għamla(iet) farmaċewtika(ċi), qawwa (iet) tal-prodott(i) mediċinali, mod(i) ta' kif jingħata, detentur(i) talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Subcutaneous Intramuscular
Maltese: Trab għall-injezzjoni
English: RORomania
Maltese: Romain
English: Saizen 8 mg/ml Solution for Injection solution for injection Subcutanous injection
Maltese: Saizen 8 mg/ml Solution for Injection
English: de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas 28108 MADRID
Maltese: Parque Empresarial La Moraleja
English: I-00176 Roma
Maltese: Casilina 125 I-00176 Roma Italy
English: Norditropin SimpleXx 5 mg / 1,5 mL solution for injection injection
Maltese: NORDITROPIN SIMPLEXx 5 mg/1.5 ml solución inyectable
English: Norditropin Nordiflex 15mg/1,5ml solution for injection subcutaneous
Maltese: NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable
English: Norditropin Nordiflex 10mg/1,5ml solution for injection subcutaneous
Maltese: NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable
English: Ivozall (clofarabine) EMA/519636/2019
Maltese: Ivozall (klofarabina) EMA/519636/2019
English: Ivozall (clofarabine)
Maltese: Ivozall (klofarabina)
English: Further information on Ivozall can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ivozall.
Maltese: ema.europa.eu/medicines/human/EPAR/ivozall.
English: Ivozall contains the active substance clofarabine and is a ‘generic medicine'.
Maltese: Ivozall fih is-sustanza attiva klofarabina u huwa ‘mediċina ġenerika'.
English: Other information about Ivozall
Maltese: Informazzjoni oħra dwar Ivozall
English: Ivozall is a cancer medicine that is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Maltese: Ivozall huwa mediċina kontra l-kanċer li tintuża biex tikkura tfal u adulti sa 21 sena b'lewkimja limfoblastika akuta (ALL), kanċer tal-limfoċiti (tip ta' ċelloli tad-demm bojod).
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Maltese: Din tappartjeni għall-grupp ta' mediċini kontra l-kanċer imsejjaħ ‘antimetaboliti'.
English: Clofarabine is an ‘analogue' of adenine, one of the building blocks of the genetic material of cells (DNA and RNA).
Maltese: Il-klofarabina hija ‘analogu' ta' adenina, li huwa wieħed mill-elementi importanti talmaterjal ġenetiku taċ-ċelloli (DNA u RNA).
English: It is available as a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala soluzzjoni għall-infużjoni (dripp) filvina.
English: How has Ivozall been studied?
Maltese: Kif ġie studjat Ivozall?
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Evoltra, and do not need to be repeated for Ivozall.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat bil-mediċina ta' referenza, Evoltra, u ma għandhomx għalfejn jiġu ripetuti għal Ivozall.
English: The active substance in Ivozall, clofarabine, is a cytotoxic agent (a medicine that kills cells that are dividing, such as cancer cells).
Maltese: Is-sustanza attiva f'Ivozall, il-klofarabina, hija aġent ċitotossiku (mediċina li toqtol ċelloli li qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer).
English: What are the benefits and risks of Ivozall?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ivozall?
English: As for all medicines, data on the use of Ivozall are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ivozall hija ssorveljata kontinwament.
English: Because Ivozall is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ivozall huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Side effects reported with Ivozall are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ivozall huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex ilpazjenti jiġu protetti.
English: This means that clofarabine resembles adenine and by taking adenine's place in the body, it interferes with the action of enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Maltese: Dan ifisser li l-klofarabina hija simili għall-adenina u filwaqt li tieħu postha fil-ġisem, din tinterferixxi mal-azzjoni ta' enzimi involuti fil-produzzjoni ta' materjal
English: Therefore, the Agency's view was that, as for Evoltra, the benefits of Ivozall outweigh the identified risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Evoltra, il-benefiċċji ta' Ivozall huma akbar mir-riskji identifikati u jista' jiġi awtorizzat għall-użu fl-UE.
English: There was no need for ‘bioequivalence' studies to investigate whether Ivozall is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' ‘bijoekwivalenza' biex jiġi investigat jekk Ivozall jiġix assorbit b'mod simili għallmediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: This is because Ivozall is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Maltese: Dan minħabba li Ivozall jingħata permezz ta' infużjoni fil-vina, għaldaqstant is-sustanza attiva tmur direttament fiċċirkolazzjoni tad-demm.
English: How does Ivozall work?
Maltese: Kif jaħdem Ivozall?
English: 5000 LT Tilburg The Netherlands
Maltese: 5000 LT Tilburg L-Olanda
English: 02130 Espoo Finland
Maltese: 02130 Espoo Il-Finlandja
English: “Adults
Maltese: “Adulti
English: 56 Eirinis Avenue 56, Pefki, 15121, Greece
Maltese: 56 Eirinis Avenue 56, Pefki, 15121, IlĠreċja
English: Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o.
Maltese: Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI
English: - SI Šmartinska 53, Ljubljana, Slovenia
Maltese: Šmartinska 53, Ljubljana, Is-Slovenja
English: - PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugal
Maltese: - PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena IlPortugall
English: • Raynaud's syndrome.
Maltese: • Sindrome ta' Raynaud.
English: Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France
Maltese: Janssen-Cilag S.A. - FR 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza
English: Queluz de Baixo 2734-503 Barcarena Portugal
Maltese: Queluz de Baixo 2734-503 Barcarena IlPortugall
English: Raynaud's phenomenon
Maltese: Fenomenu ta' Raynaud's
English: Paediatric population (pharmacokinetics, up to 12 years of age)
Maltese: Tfal (farmakokinetika, sa 12-il sena)
English: • Gas
Maltese: • Gass
English: Generally, 13 to 17% of topiramate is bound to plasma protein.
Maltese: Ġeneralment, minn 13% sa 17% ta' topiramate jeħel mal-proteini tal-plasma.