FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: Francuska Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Maltese: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Croatian: 08019 Barcelona
Maltese: 08019 Barcelona Spanja
Croatian: Norton Healthcare Limited Ridings Point, Whistler Drive
Maltese: Ir-Renju Unit Norton Healthcare Limited Ridings Point, Whistler Drive
Croatian: 63741 Aschaffenburg Germany
Maltese: 63741 Aschaffenburg
Croatian: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Maltese: Professor Doutor Cavaco Silva, 10 E 2740-255
Croatian: Španjolska Genfarma Laboratorio, S.L. Cólquide 6, portal 2º, 1ª planta.
Maltese: Genfarma Laboratorio, S.L. Cólquide 6, portal 2º, 1ª planta.
Croatian: 1099-036 Lisboa Portugal
Maltese: 1099-036 Lisboa Il-Portugall
Croatian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Maltese: Il-Latvja sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Croatian: Francuska Ranbaxy Pharmacie Génériques
Maltese: Ranbaxy Pharmacie Génériques
Croatian: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Maltese: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Ċipru
Croatian: 85101 Bratislava Slovak Republic
Maltese: 85101 Bratislava
Croatian: Teva UK Limited Brampton Road, Hampden Park
Maltese: Ir-Renju Unit Teva UK Limited Brampton Road, Hampden Park
Croatian: 1020 Bruxelles
Maltese: 1080 Brussels
Croatian: Španjolska SANOFI AVENTIS, S.A. Josep Plá, 2
Maltese: AVENTIS, S.A. Josep Plá, 2
Croatian: 11-15 Quai Dion Bouton 92800 Puteaux
Maltese: Quai Dion Bouton 92800 Puteaux Franza
Croatian: Luksemburg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Maltese: Takeda Belgium Chaussée de Gand 615 1080
Croatian: Eurogenerics N.V.
Maltese: Il-Belġju Eurogenerics N.V.
Croatian: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Maltese: Sandoz GmbH Biochemiestrasse 10 6250
Croatian: Njemačka Heumann Pharma GmbH & Co.
Maltese: Il-Ġermanja Heumann Pharma GmbH & Co.
Croatian: Bugarska Sanofi-Aventis Bulgaria EOOD
Maltese: Il-Bulgarija Sanofi-Aventis Bulgaria EOOD
Croatian: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Maltese: Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR L-Olanda
Croatian: Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Prague 6
Maltese: Evropská 846/176a 160 00 Prague 6
Croatian: 02101 Espoo Finland
Maltese: 02101 Espoo
Croatian: Njemačka Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Maltese: Il-Ġermanja Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Croatian: Orion Corporation Orionintie 1 A FI-02200 Espoo Finland
Maltese: Orion Corporation Orionintie 1 A FI-02200
Croatian: Slovenija Sanofi-Aventis d.o.o. Dunajska cesta 151
Maltese: Is-Slovenja Sanofi-Aventis d.o.o. Dunajska cesta 151
Croatian: PSC 170 00 Holesovice Czech Republic magnezijev valproat
Maltese: PSC 170 00 Holesovice Ir-Repubblika Ċeka
Croatian: Veluwezoom 22 1327 AH ALMERE The Netherlands
Maltese: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE L-Olanda
Croatian: Nizozemska Sanofi-Aventis Netherlands B.V.
Maltese: Sanofi-Aventis Netherlands B.V.
Croatian: Austrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Maltese: L-Awstrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Croatian: Depakine sirup
Maltese: Depakine sirop
Croatian: Convulsofin Tabletten tablet
Maltese: Convulsofin Tabletten
Croatian: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Maltese: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm
Croatian: Njemačka Stadapharm GmbH Stadastr 2-18
Maltese: Il-Ġermanja Stadapharm GmbH Stadastr 2-18
Croatian: Luksemburg Eurogenerics SA Esplanade Heysel b22
Maltese: Eurogenerics SA Esplanade Heysel b22 1020
Croatian: Njemačka Mylan dura GmbH Wittichstr.
Maltese: Il-Ġermanja Mylan dura GmbH Wittichstr.
Croatian: UAB „SANOFI-AVENTIS LIETUVA"
Maltese: Il-Litwanja UAB „SANOFI-AVENTIS LIETUVA"
Croatian: Luksemburg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Maltese: Industriestrasse 25 83067 Holzkirchen Il-Ġermanja
Croatian: Luksemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Maltese: Il-Belġju Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Croatian: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution oralna otopina
Maltese: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution
Croatian: Sanofi-Aventis Sp. z o.o. 17 Bonifraterska Str. 00-203 Warsaw Poland
Maltese: Sp. z o.o. 17 Bonifraterska Str. 00-203 Warsaw Il-Polonja
Croatian: Njemačka Sanofi-Aventis Deutschland GmbH
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH
Croatian: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml oralna tekućina
Maltese: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml
Croatian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
Maltese: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Il-Belġju
Croatian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
Maltese: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Il-Belġju
Croatian: Sanofi Malta Ltd St. Julian's Rd., San Gwann SGN 2805 Malta
Maltese: Julian's Rd., San Gwann SGN 2805
Croatian: Luksemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Maltese: Il-Belġju Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Croatian: Darwinweg 20 2333 CR LEIDEN The Netherlands
Maltese: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN L-Olanda
Croatian: 167 14 Bromma Sweden
Maltese: 167 14 Bromma L-Isvezja
Croatian: Edvard Thomsens Vej 14 DK-2300 København
Maltese: Id-Danimarka Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Id-Danimarka
Croatian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Maltese: Wrexham Industrial Estate Wrexham, LL13 9UF
Croatian: Hrvatska Sanofi-Aventis Croatia d.o.o.
Maltese: Sanofi-Aventis Croatia d.o.o.
Croatian: Swensweg 5 2031 GA HAARLEM The Netherlands
Maltese: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM
Croatian: Sanofi Oy Huopalahdentie 24 PL 22
Maltese: Il-Finlandja Sanofi Oy Huopalahdentie 24
Croatian: Winthrop Pharmaceuticals UK Limited
Maltese: Ir-Renju Unit Winthrop Pharmaceuticals UK Limited
Croatian: Ácido Valpróico Generis
Maltese: Valproic acid Ácido Valpróico Generis
Croatian: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Maltese: Ir-Renju Unit Generics UK Limited Station Close, Potter's Bar Hertfordshire
Croatian: Valproinsäure- ratiopharm Lösung oralna otopina
Maltese: Valproinsäure- ratiopharm Lösung
Croatian: kapsula, meka
Maltese: Kapsula, ratba
Croatian: Njemačka TAD Pharma GmbH Heinz-Lohmann-Str.
Maltese: Il-Ġermanja TAD Pharma GmbH Heinz-Lohmann-Str.
Croatian: Via Scarlatti Domenico, 31 20124 Milano Italy valproatna kiselina, natrijev valproat
Maltese: Via Scarlatti Domenico, 31 20124
Croatian: Depakine suikervrije stroop, drank 200 mg/5 ml oralna otopina
Maltese: Depakine suikervrije stroop, drank 200 mg/5 ml
Croatian: Mađarska Sanofi-Aventis zrt.
Maltese: L-Ungerija Sanofi-Aventis zrt.
Croatian: Germany espa-valept 300 mg retard 199,8 mg, 87 mg
Maltese: Berlin espa-valept 300 mg retard 199.8 mg, 87 mg
Croatian: Njemačka Orion Corporation Orionintie 1 A
Maltese: Il-Ġermanja Orion Corporation Orionintie 1 A
Croatian: Njemačka Neuraxpharm Arzneimittel GmbH
Maltese: Il-Ġermanja Neuraxpharm Arzneimittel GmbH
Croatian: Rua Tierno GalvanAmoreiras - Torre 3 - 12º Lisboa
Maltese: - Torre 3 - 12º Lisboa
Croatian: National Highway 14568 Kryoneri Greece
Maltese: DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Il-Greċja
Croatian: Slovenia
Maltese: Is-Slovenja
Croatian: DEPAKINE 57,64 mg/ml, sirop 57,64 mg sirup
Maltese: DEPAKINE 57,64 mg/ml, sirop 57.64 mg
Croatian: Francuska LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf
Maltese: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette Franza
Croatian: 65926 Frankurt am main Germany
Maltese: 65926 Frankurt am main Il-Ġermanja
Croatian: Epilim 100mg Crushable Tablet tableta
Maltese: Epilim 100mg Crushable Tablet
Croatian: Epilim 100 mg Crushable Tablets tableta
Maltese: Epilim 100 mg Crushable Tablets
Croatian: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable otopina za injekciju u venu
Maltese: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable
Croatian: Valpro TAD Lösung oralna otopina
Maltese: Valpro TAD Lösung
Croatian: Depakine Chronosphere 250 166,76 mg + 72,61 mg granule s produljenim oslobađanjem
Maltese: Depakine Chronosphere 250 166.76 mg 72.61 mg
Croatian: 64295 Darmstadt Germany valprodura 150mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 150mg
Croatian: Njemačka ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Maltese: Il-Ġermanja ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Croatian: Sodium Valproate Oral solution BP 200mg/5ml oralna otopina
Maltese: Sodium valproate Oral solution BP 200mg/5ml
Croatian: Epilim 400mg Powder & solvent for solution for injection prašak za injekciju u venu
Maltese: Epilim 400mg Powder & solvent for solution for injection
Croatian: Depakine Chronosphere 750 500,06 mg + 217,75 mg granule s produljenim oslobađanjem
Maltese: Depakine Chronosphere 750 500,06 mg 217,75 mg
Croatian: Njemačka Winthrop Arzneimittel GmbH
Maltese: Il-Ġermanja Winthrop Arzneimittel GmbH
Croatian: Convulex 50 mg/ml syrup 50 mg/ml sirup
Maltese: Convulex 50 mg/ml syrup 50 mg/ml
Croatian: Depakine 57,64 mg/ml syrup 57,64 mg/ml sirup
Maltese: Depakine 57,64 mg/ml syrup 57.64 mg/ml
Croatian: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Italy
Maltese: Italia Srl Viale Bodio 37/B 20158 Milano L-Italja
Croatian: Depakine Chronosphere 100 66,66 mg + 29,03 mg granule s produljenim oslobađanjem
Maltese: Depakine Chronosphere 100 66,66 mg 29,03 mg
Croatian: Sodium valproate liquid 200mg/5ml oralna otopina
Maltese: Sodium valproate liquid 200mg/5ml
Croatian: 64295 Darmstadt Germany valprodura 600 mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 600 mg
Croatian: 64295 Darmstadt Germany valprodura 300 mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 300 mg
Croatian: Depakine Enteric 150 mg 150 mg tablet
Maltese: Depakine Enteric 150 mg 150 mg
Croatian: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg tableta s prilagođenim oslobađanjem
Maltese: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg
Croatian: Italy magnezijev valproat
Maltese: Magnesium Valproate
Croatian: 500 mg/vrećica želučanootporna tableta
Maltese: 500 mg/sachet Pillola gastroreżistenti
Croatian: 200 mg/tableta želučanootporna tableta
Maltese: 200 mg/tab Pillola gastroreżistenti
Croatian: Natriumvalproaat Apotex 300 mg/5 ml, drank oralna otopina
Maltese: Natriumvalproaat Apotex 300 mg/5 ml, drank
Croatian: Convulex 100 mg/ml solution for injection/concentrate for solution for infusion otopina za injekciju/infuziju u venu
Maltese: Convulex 100 mg/ml solution for injection/concentrate for solution for infusion
Croatian: Germany espa-valept 500 mg retard 333 mg, 145 mg
Maltese: Berlin espa-valept 500 mg retard 333 mg, 145 mg
Croatian: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg tableta s prilagođenim oslobađanjem
Maltese: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg
Croatian: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Maltese: Pharma Limited One Onslow Street
Croatian: Depakine i.v. 400, poeder voor injectievloeistof 400 mg prašak i otapalo za otopinu za injekciju u venu
Maltese: Depakine i.v. 400, poeder voor injectievloeistof 400 mg
Croatian: Spain valpromid Depamide 300 mg comprimidos gastrorresistentes
Maltese: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Croatian: H-1045 Budapest Hungary
Maltese: H-1045
Croatian: Valproat HEXAL 300mg/ml Lösung oralna otopina
Maltese: Valproat HEXAL 300mg/ml Lösung
Croatian: One Onslow Street Guildford, Surrey GU1 4YS
Maltese: Guildford, Surrey
Croatian: Diplexil 1000
Maltese: Valproic acid Diplexil 1000
Croatian: Sodium valproate 100mg/ml solution for injection or infusion otopina za injekciju/infuziju u venu
Maltese: Sodium valproate 100mg/ml solution for injection or infusion
Croatian: Depakine 300 mg/ml Tropfen 300 mg/ml oralna otopina
Maltese: Depakine 300 mg/ml Tropfen 300 mg/ml
Croatian: Depakine Chronosphere 1000 666,60 mg + 290,27 mg granule s produljenim oslobađanjem
Maltese: Depakine Chronosphere 1000 666,60 mg 290.
Croatian: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable oralna otopina
Maltese: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable
Croatian: France valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Maltese: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u državama članicama
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
Croatian: Rumunjska Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Ir-Rumanija Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Croatian: Convulex gelule gastro résistante želučanootporna kapsula
Maltese: Valproic acid Convulex gelule gastro résistante
Croatian: Orfiril Injektionslösung otopina za injekciju u venu
Maltese: Orfiril Injektionslösung
Croatian: Heizel Esplanade b22 1020 Brussels Belgium
Maltese: Heizel Esplanade b22
Croatian: Episenta solution for injection 100 mg/ml otopina za injekciju u venu
Maltese: Episenta solution for injection 100 mg/ml
Croatian: 2a
Maltese: Benzstr. 2a
Croatian: Depakine 300 mg/5 ml sirup
Maltese: Depakine 300 mg/5 ml
Croatian: Rumunjska Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Maltese: Ir-Rumanija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Croatian: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Maltese: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte
Croatian: 92517 Boulogne Billancourt Cedex
Maltese: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Croatian: Sanofi-Aventis S.P.A. Viale Luigi Bodio 37/b 20158 Milano Italy
Maltese: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano L-Italja
Croatian: Bulgaria
Maltese: Il-Bulgarija
Croatian: Convulex 300 mg/ml oral solution oralna otopina
Maltese: Convulex 300 mg/ml oral solution
Croatian: Njemačka Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Croatian: Depakine 100 mg/ml polvo y disolvente para solución inyectable prašak i otapalo za otopinu za injekciju u venu
Maltese: Depakine 100 mg/ml polvo y disolvente para solución inyectable
Croatian: Francuska Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Maltese: Il-Finlandja Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Croatian: Orfiril CR 500 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Maltese: Orfiril CR 500 mg, granulaat met gereguleerde afgifte
Croatian: Francuska Ratiopharm GmbH Graf-Arco-Strasse 3
Maltese: Il-Ġermanja Ratiopharm GmbH Graf-Arco-Strasse 3
Croatian: Depakine Enteric 300 mg 300 mg tablet
Maltese: Depakine Enteric 300 mg 300 mg
Croatian: kapsula s produljenim oslobađanjem
Maltese: Kapsula gastroreżistenti
Croatian: 12 siječnja 2015.
Maltese: 12 ta' Jannar 2015
Croatian: Implementacija sporazuma od strane država članica (dostavljanje izmjene za implementaciju izmjena u informacijama o proizvodu od strane nositelja odobrenja za stavljanje lijeka u promet):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (sottomissjoni tal-varjazzjoni biex jiġu implimentanti l-bidliet fl-informazzjoni dwar ilprodott mid-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq):
Croatian: Edukacijski se materijali trebaju dostaviti istovremeni s izmjenama primjene informacija o proizvodu.
Maltese: Il-materjal edukattiv għandu jiġi sottomess flimkien mal-varjazzjoni tal-applikazzjoni għallinformazzjoni dwar il-prodott.
Croatian: Prosljeđivanje prijevoda dodatka sporazumu nadležnim nacionalnim tijelima:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għallftehim:
Croatian: EMA/248364/2019 Rev1
Maltese: 17 ta' April 2019 EMA/248364/2019 Rev1
Croatian: kandesartan (32 mg) irbesartan (300 mg) losartan (150 mg) olmesartan (40 mg) valsartan (320 mg)
Maltese: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
Croatian: Djelatna tvar (maksimalna dnevna doza)
Maltese: Sustanza attiva kuljum)
Croatian: EMA i nacionalna tijela nastavit će s istraživanjem prisutnosti nitrozaminskih onečišćenja u lijekovima, uključujući druga onečišćenja kao što su N-nitrozo-etilizopropilamin (EIPNA), N-nitrozo-dizopropilamin (DIPNA) i N-nitrozo-N-metilamino butirična kiselina (NMBA).
Maltese: L-EMA u l-awtoritajiet nazzjonali se jkomplu jinvestigaw il-preżenza ta' impuritajiet tan-nitrożammini fil-mediċini, inklużi impuritajiet oħra bħal N-nitrożoetilisopropilammina (EIPNA), Nnitrożodiisopropilammina (DIPNA) u N-nitrożo-N-metilamino-aċidu butiriku (NMBA).
Croatian: Ocjenjivanje je 20. rujna 2018. prošireno na lijekove koji sadržavaju kandesartan, irbesartan, losartan i olmesartan.
Maltese: Fl-20 ta' Settembru 2018, ir-rieżami ġie estiż biex jinkludi mediċini li fihom candesartan, irbesartan, losartan u olmesartan.
Croatian: Table 1. Privremene granične vrijednosti za nečistoće u obliku NDMA i NDEA NDMA
Maltese: Limiti temporanji għall-NDMA u l-NDEA, impuritajiet NDMA
Croatian: Istraživanje se nastavlja
Maltese: Investigazzjoni li tkompli
Croatian: Te se granične vrijednosti temelje na maksimalnom dnevnom unosu svake nečistoće i proizlaze iz ispitivanja provedenih na životinjama: 96,0 nanograma za NDMA i 26,5 nanograma za NDEA.
Maltese: Il-limiti huma bbażati fuq id-doża massima ta' kuljum għal kull impurità derivata mill-istudji fuq lannimali: 96.0 nanogrammi għall-NDMA u 26.5 nanogrammi għall-NDEA.
Croatian: Zaključeno je da kad bi 100 000 bolesnika uzimalo najveću dozu valsartana proizvođača Zhejiang Huahai (u kojemu su utvrđene najveće razine nečistoća) svakodnevno tijekom šest godina, tijekom života tih 100 000 bolesnika mogla bi se pojaviti dodatna 22 slučaja raka koje je prouzročila tvar NDMA.
Maltese: Huwa kkonkluda li jekk 100,000 pazjent ħadu valsartan minn Zhejiang Huahai (fejn instabu l-ogħla livelli ta' impuritajiet) kuljum għal 6 snin fl-ogħla doża, jista' jkun hemm 22 każ addizzjonali ta' kanċer minħabba l-NDMA tul il-ħajja ta' dawk il-100,000 pazjent.
Croatian: 1 Razdoblja od šest godina i četiri godine odnose se na razdoblje za koje se smatra da su tvari NDMA i NDEA prisutne u valsartanu proizvođača Zhejiang Huahai.
Maltese: 1 Is-snin 6 u 4 jirreferu għat-tul ta' żmien li l-NDMA u l-NDEA huma maħsuba li kienu preżenti f'valsartan minn Zhejiang Huahai
Croatian: Ocjenjivanje se odnosi na kandesartan, irbesartan, losartan, olmesartan i valsartan, koji pripadaju skupini lijekova naziva sartani (poznati i kao antagonisti receptora angiotenzina II).
Maltese: Ir-rieżami jikkonċerna candesartan, irbesartan, losartan, olmesartan u valsartan, li jappartjenu għal klassi ta' mediċini msejħin sartans (magħrufin ukoll bħala antagonisti tar-riċetturi tal-anġjotensina
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je u razdoblju od 2. do 17. travnja 2019. donijela konačne pravno obvezujuće odluke o predmetnim lijekovima koje se primjenjuju u svim državama članicama EU-a.
Maltese: Lopinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjonijiet legalment vinkolanti finali għall-mediċini kkonċernati bejn it-2 ta' April u s-17 ta' April 2019 li huma applikabbli fl-Istati Membri kollha tal-UE.
Croatian: Sličan korak, koji obuhvaća dietilamin (DEA), povezan je s prisutnošću tvari NDEA.
Maltese: Pass simili - li jinvolvi dietilammina (DEA) - huwa marbut mal-preżenza tal-NDEA.
Croatian: Prije lipnja 2018. tvari NDMA i NDEA nisu se nalazile među nečistoćama utvrđenima u lijekovima iz skupine sartana i stoga nisu bile otkrivene rutinskim ispitivanjima.
Maltese: Qabel Ġunju 2018, l-NDMA u l-NDEA ma kinux fost l-impuritajiet identifikati fil-mediċini sartan u għalhekk ma nstabux permezz ta' testijiet ta' rutina.
Croatian: Ove se preporuke nadovezuju na ocjenjivanje N-nitrozodimetilamina (NDMA) i N-nitrozodietilamina (NDEA), koji su kategorizirani kao tvari za koje se pretpostavlja da su karcinogene za ljude (tvari koje mogu uzrokovati rak) i koje su otkrivene u određenim lijekovima iz skupine sartana, koje je provela EMA.
Maltese: Dawn ir-rakkomandazzjonijiet isegwu r-rieżami tal-EMA ta' N-nitrożodimetilammina (NDMA) u Nnitrożodietilammina (NDEA), li huma kklassifikati bħala karċinoġeni umani probabbli (sustanzi li jistgħu jikkawżaw il-kanċer) u ġew skoperti f'xi mediċini sartan.
Croatian: McDermott Laboratories Limited t/a Gerard Laboratories Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Maltese: McDermott Laboratories Limited T/A Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
Maltese: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: 117 Allée des parcs 69800 Saint Priest Francuska
Maltese: 117 Allée des Parcs, Saint-Priest, 69800, Franza
Croatian: Mylan utca 1, Komárom - 2900 Mađarska
Maltese: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900
Croatian: NDMA Graničn a vrijednos t u ng/dan
Maltese: NDMA Limitu f'ng/ġurnata
Croatian: Datum prvog odobrenja: 22 Ožujak 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Marzu 2016
Croatian: NDEA Graničn a vrijednos t u ng/dan
Maltese: NDEA Limitu f'ng/ġurnata
Croatian: Konfuzija.
Maltese: • konfużjoni
Croatian: Mylan Hungary Kft.
Maltese: Mylan Hungary Kft./Mylan Hungary Ltd.
Croatian: Nuspojave su podijeljene prema učestalosti koja se definira kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podatka).
Maltese: F'kull klassifikazzjoni ta' frekwenza, l-effetti mhux mixtieqa huma preżentati f'ordni li tibda mill-iktar effetti serji u tispiċċa fl-inqas effetti serji: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari ( ≥ 1/10,000 sa < 1/1,000); mhux magħrufa (ma jistgħux jiġu kkalkolati mill-informazzjoni eżistenti).
Croatian: CYP3A4 inhibitori
Maltese: CYP3A4 > CYP2D6.
Croatian: Zatajivanje srca/poslije infarkta miokarda
Maltese: Mhux komuni Infart mijokardijaku
Croatian: Drugi izvori informacija
Maltese: Informazzjoni Importanti
Croatian: Stevens-Johnsonov sindrom -
Maltese: Sindromu Stevens Johnson, Nekroliżi tossika tal-epidermide (TEN)
Croatian: Toksična epidermalna nekroliza
Maltese: Mediċini Anti-bijotiċi Fusidic Acid
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva
Maltese: Disturbi muskolu-skeltrali u talconnective tissue
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon, magnezijev stearat, koloidni bezvodni silicijev dioksid, hipromeloza, makrogol 8000, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172).
Maltese: Ir-rita ta' barra tal-pillola hija magħmula minn: hypromellose, titanium dioxide (E171), macrogols, hydroxypropylcellulose, talc, iron oxide yellow (E172), colloidal anhydrous silica, polysorbate 80.
Croatian: Poremećaji uha ilabirinta
Maltese: Doża ta' soluzzjoni orali
Croatian: Amlodipin (mg)
Maltese: Doża ta' ritonavir (mg)
Croatian: NDMA Granična vrijednost u aktivnim farmaceutski m sastojcima (ppm)
Maltese: NDMA Limitu f'ppm fl-API
Croatian: EMA/78333/2016 EMEA/H/C/004037
Maltese: EMA/78333/2016 EMA/H/C/004037
Croatian: Amlodipin/Valsartan Mylan EMA/78333/2016
Maltese: Amlodipine/Valsartan Mylan EMA/78333/2016
Croatian: Amlodipin/Valsartan Mylan dostupan je u obliku tableta (5 mg amlodipina i 80 mg valsartana; 5 mg amlodipina i 160 mg valsartana; 10 mg amlodipina i 160 mg valsartana).
Maltese: Amlodipine/Valsartan Mylan huwa disponibbli bħala pilloli (5 mg amlodipina u 80 mg valsartan; 5 mg amlodipina u 160 mg valsartan; 10 mg amlodipina u 160 mg valsartan).