FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: Za lijekove koje država članica EU-a (ili više njih) smatra izrazito važnima, nositelji odobrenja za stavljanje lijeka u promet dostavit će ispitivanje bioekvivalencije provedeno u odnosu na referentni lijek odobren u EU-u unutar 12 mjeseci od donošenja odluke Komisije.
Latvian: ES dalībvalstīm uzskata zāles par vitāli nepieciešamām, attiecīgo zāļu reģistrācijas apliecības īpašniekam ir jāiesniedz informācija par šo zāļu un ES atsauces zāļu bioekvivalences pētījumu, kas īstenots 12 mēnešu laikā no Komisijas lēmuma pieņemšanas dienas;
Croatian: Direktive 2001/83/EZ ne mogu se smatrati ispunjenima te se djelotvornost i sigurnost navedenih lijekova ne može se utvrditi te se stoga omjer koristi i rizika ne može smatrati pozitivnim.
Latvian: Ja zāļu bioekvivalence ar ES atsauces zālēm netiek pierādīta, Direktīvas 2001/83/EK 10. pantā noteiktās prasības ir atzīstamas par neizpildītām, attiecīgo zāļu efektivitāte un drošums nav nosakāmi un tādējādi šo zāļu ieguvumu un riska attiecība nav uzskatāma par pozitīvu.
Croatian: Potrebno je obustaviti odobrenja za stavljanje u promet lijekova za koje nisu dostavljeni podatci ili obrazloženja o bioekvivalenciji ili za koje podatci i obrazloženja o bioekvivalenciji prema mišljenju CHMP-a nisu dostatni za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u s obzirom na to da su određeni podatci koji potkrepljuju odobrenja za stavljanje lijeka u promet netočni te da se omjer koristi i rizika tih odobrenja za stavljanje lijeka u promet ne smatra povoljnim u skladu s člankom 116.
Latvian: reģistrācijas apliecību darbība zālēm, par kurām bioekvivalences dati vai pamatojums netika iesniegti vai par kurām iesniegtos datus CHMP uzskatīja par nepietiekamiem, lai noteiktu bioekvivalenci ar ES atsauces zālēm, ir jāaptur, jo dati, ar kuriem pamatoja reģistrācijas apliecības, nav pareizi un saskaņā ar Direktīvas 2001/83/EK 116. pantu šo reģistrācijas apliecību ieguvumu un riska attiecība nav uzskatāma par pozitīvu.
Croatian: Ako tijekom tog razdoblja država članica EU-a (ili više njih) ocijeni da lijek više nije izrazito važan, primijenit će se obustava dotičnog/dotičnih odobrenja za stavljanje lijeka u promet.
Latvian: Ja šajā periodā ES dalībvalsts nolemj, ka zāles vairs nav uzskatāmas par vitāli nepieciešamām, attiecīgās(-o) reģistrācijas apliecības(-u) darbība ir jāaptur.
Croatian: Države članice EU-a mogu zaključiti da je lijek izrazito važan na temelju ocjene potencijalno neudovoljene medicinske potrebe, uzimajući u obzir dostupnost odgovarajućih alternativnih lijekova u dotičnim državama članicama EU-a i, ako je primjereno, prirodu bolesti koja će se liječiti.
Latvian: Lēmumu atzīt kādu no reģistrētajām zālēm par vitāli nepieciešamām ES dalībvalstis pieņem, izvērtējot gan medicīnas nozares vajadzības, ko citādi nevar apmierināt, gan attiecīgi ārstējamo slimību, kā arī apsverot piemērotu alternatīvo zāļu pieejamību attiecīgajās ES dalībvalstīs.
Croatian: Kako bi se ukinula obustava odobrenja za stavljanje lijeka u promet, nositelj odobrenja za stavljanje lijeka u promet mora dokazati bioekvivalenciju u odnosu na referentni lijek, odobrenu u EU-u na temelju relevantnih podataka, u skladu sa zahtjevima iz članka 10.
Latvian: Pirms reģistrācijas apliecību darbības apturēšanas reģistrācijas apliecības īpašniekam ir jāuzrāda bioekvivalences dati ar derīgām ES atsauces zālēm, pamatojoties uz attiecīgiem datiem atbilstoši Direktīvas 2001/83/EK 10. panta prasībām (piemēram, veikts bioekvivalences pētījums ar ES atsauces zālēm).
Croatian: U slučaju odobrenja za stavljanje u promet lijeka koji se smatra izrazito važnim obustava se u relevantnim državama članicama može odgoditi na razdoblje koje ne smije biti dulje od 24 mjeseca od dana donošenja odluke Komisije.
Latvian: ES dalībvalstī(s) var atlikt uz periodu, kas nepārsniedz divdesmit četrus (24) mēnešus no Komisijas lēmuma pieņemšanas dienas.
Croatian: Za zahtjeve za odobrenja za stavljanje lijeka u promet navedene u Prilogu I.a mišljenja CHIMPa utvrđena je bioekvivalencija u odnosu na valjani referentni lijek odobren u EU-u.
Latvian: d. Bioekvivalence ar apstiprinātām ES atsauces zālēm tika noteikta CHMP atzinuma Ia pielikumā uzskaitītajiem reģistrācijas apliecību pieteikumiem.
Croatian: KG (u Njemačkoj)
Latvian: KG (Vācijā)
Croatian: EG LABOLaboratoires Eurogenerics
Latvian: Francija EG LABOLaboratoires Eurogenerics
Croatian: Napritum naproksen
Latvian: Napritum naproksēns
Croatian: Kinedexe UK Limited (prethodno NRIM Limited)
Latvian: Kinedexe UK Limited (iepriekš NRIM Limited)
Croatian: Španjolska QUALIGEN, SL
Latvian: Spānija QUALIGEN, SL
Croatian: Hexal AG, Njemačka
Latvian: Hexal AG, Germany
Croatian: Sanofi Aventis France
Latvian: Francija Sanofi Aventis France
Croatian: ZYDUS France
Latvian: Francija ZYDUS France
Croatian: Teva Sante
Latvian: Francija Teva Sante
Croatian: Prilog I.b: Lijekovi za koje se preporučuje obustava odobrenja za stavljanje lijeka u promet i zahtjevi za odobrenje za stavljanje lijeka u promet koji ne udovoljavaju kriterijima za izdavanje odobrenja
Latvian: Ib pielikums Zāles, kurām ieteikts apturēt reģistrācijas apliecību darbību, un reģistrācijas apliecību pieteikumi, kuri neatbilst reģistrācijas apliecības piešķiršanas kritērijiem
Croatian: LABORATORIOS CINFA, SA
Latvian: LABORATORIO S CINFA, SA
Croatian: BRADEX AEBE DUTASTERIDE/BRADEX dutasterid
Latvian: BRADEX AEBE DUTASTERIDE/BRADEX
Croatian: Carbocisteine 375 mg Capsules, Hard karbocistein
Latvian: Carbocisteine 375 mg Capsules, Hard karbocisteīns
Croatian: Španjolska Strides Arcolab International
Latvian: Spānija Strides Arcolab International
Croatian: Metoklopramid Alternova metoklopramid
Latvian: Metoklopramid Alternova metoklopramīds
Croatian: Lupin (Europe) Limited
Latvian: Lupin (Europe)
Croatian: Baclofeno Generis baklofen
Latvian: Baclofeno Generis baklofēns
Croatian: dutasterid
Latvian: dutasterīds
Croatian: Alternova A/S Hydrokortison Alternova hidrokortizon
Latvian: Alternova A/S Hydrokortison Alternova hidrokortizons
Croatian: ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. PHARMAZAC AE
Latvian: ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ.
Croatian: Prilog I.a: Lijekovi za koje se preporučuje zadržavanje odobrenja za stavljanje lijeka u promet i zahtjevi za odobrenje za stavljanje lijeka u promet za koje je utvrđena bioekvivalencija u odnosu na referentni lijek odobren u EU-u
Latvian: Zāles, ko iesaka uzturošai terapijai un reģistrācijas apliecību pieteikumi, kuriem noteikta bioekvivalence ar ES atsauces zālēm
Croatian: Bendro-flumetiazid Alternova bendroflumetiazid 2,5 mg tableta
Latvian: Bendro-flumetiazid Alternova bendroflumetiazīds 2,5 mg Tablete
Croatian: Sandoz n.v./s.a.
Latvian: Beļģija Sandoz n.v./s.a.
Croatian: acide ursodesoxycholique Inopharm ursodeoksikolatna kiselina
Latvian: acide ursodesoxycholique Inopharm ursodezoksiholskābe
Croatian: paracetamol
Latvian: paracetamols
Croatian: Dicloxacillin Alternova dikloksacilin
Latvian: Dicloxacillin Alternova dikloksacilīns
Croatian: Orion Corporation Orion Pharma, Finska
Latvian: Somija Orion Corporation Orion Pharma, Finland
Croatian: Bupropion Orion bupropion
Latvian: Bupropion Orion bupropions
Croatian: Buproprionhydrochlorid Hexal 300 mg bupropion
Latvian: Buproprionhydrochlorid Hexal 300 mg bupropions
Croatian: Alternova A/S Baklofen Alternova baklofen
Latvian: Alternova A/S Baklofen Alternova baklofēns
Croatian: Belfada aripiprazol
Latvian: Belfada aripiprazols
Croatian: Glob Ltd.
Latvian: Portugāle Glob Ltd.
Croatian: Alternova A/S Etodolac Alternova etodolak
Latvian: Alternova A/S Etodolac Alternova etodolaks
Croatian: Morysa memantin
Latvian: Morysa memantīns
Croatian: hidrokortizon
Latvian: hidrokortizons
Croatian: Loperamid Orifarm loperamid
Latvian: Loperamid Orifarm loperamīds
Croatian: SUBSTIPHARM DEVELOPPEMENT
Latvian: SUBSTIPHARM DEVELOPPEME NT
Croatian: Paracetamol Almus Pharma paracetamol
Latvian: Paracetamol Almus Pharma paracetamols
Croatian: Bupropion 1 A Pharma 300 mg bupropion
Latvian: Bupropion 1 A Pharma 300 mg bupropions
Croatian: Španjolska LABORATORIOS COMBIX, SLU
Latvian: Spānija LABORATORIO S COMBIX,
Croatian: Španjolska AUROVITAS SPAIN, SAU
Latvian: Spānija AUROVITAS SPAIN, SAU
Croatian: Sandoz A/S, Danska
Latvian: Somija Sandoz A/S, Denmark
Croatian: Sodium Cromoglicate 100mg hard Capsules natrijev kromoglikat 100 mg kapsula, tvrda peroralna primjena
Latvian: Sodium Cromoglicate 100 mg hard Capsules nātrija kromoglikāts
Croatian: Pharmascope
Latvian: PHARMAZAC
Croatian: Etrixenal naproksen
Latvian: Etrixenal naproksēns
Croatian: Memantine Pharmascope memantin
Latvian: Memantine Pharmascope memantīns
Croatian: Prednisolon Alternova prednisolon
Latvian: Prednisolon Alternova prednizolons
Croatian: 1 A Pharma GmbH, Njemačka
Latvian: 1 A Pharma GmbH, Germany
Croatian: Laboratórios BasiIndústria Farm
Latvian: Indústria Farm
Croatian: Mylan SAS
Latvian: Francija Mylan SAS
Croatian: bupropion
Latvian: bupropions
Croatian: Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropion
Latvian: Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropions
Croatian: Atyxine hidroksizin
Latvian: Atyxine hidroksizīns
Croatian: hidroksizin
Latvian: hidroksizīns
Croatian: Omega 3-acid-ethyl esters 1000mg soft capsules etilni[90]esteri omega-3 kiselina
Latvian: Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-skābes etilesteri
Croatian: MIKROGRAMŮ/30 MIKROGRAMŮ
Latvian: LARCIA 125 MIKROGRAMŮ/30 MIKROGRAMŮ
Croatian: Beta-histina Bluefish betahistin
Latvian: Beta-histina Bluefish betahistīns
Croatian: Sandoz A/S
Latvian: Zviedrija Sandoz A/S
Croatian: Španjolska SANDOZ FARMACEUTICA, SA
Latvian: Spānija SANDOZ FARMACEUTIC A, SA
Croatian: Naproxen Orion naproksen
Latvian: Naproxen Orion naproksēns
Croatian: Arrow Génériques
Latvian: Francija Arrow Génériques
Croatian: Rumunjska Proenzi s.r.o.
Latvian: Rumānija Proenzi s.r.o.
Croatian: Generic Speciality Pharma Limited
Latvian: Speciality Pharma Limited
Croatian: Pharma Bavaria International (PBI) Portugal, Unip.
Latvian: Pharma Bavaria International (PBI)
Croatian: BETAHISTIN
Latvian: betahistīns
Croatian: Bupropion Sandoz 300 mg tablete s prirejenim sproščanjem bupropion
Latvian: Bupropion Sandoz 300 mg tablete s prirejenim sproščanjem bupropions
Croatian: Aurobindo Pharma Ltd, Malta
Latvian: Somija Aurobindo Pharma Ltd, Malta
Croatian: Clindamycin Alternova klindamicin
Latvian: Clindamycin Alternova klindamicīns
Croatian: vorikonazol
Latvian: vorikonazols
Croatian: Generis Farmacêutica, S.A.
Latvian: Portugāle Generis Farmacêutica, S.A.
Croatian: Bluefish Pharmaceuticals AB
Latvian: Bluefish Pharmaceutical s AB
Croatian: Hydroxyzine hydrochloride 25mg film-coated tablets hidroksizin hidroklorid 25 mg filmom obložena tableta
Latvian: Hydroxyzine hydrochloride 25 mg film-coated tablets hidroksizīna hidrohlorīds 25 mg
Croatian: Omega 3 Strides Arcolab International etilni[90]esteri omega-3 kiselina
Latvian: Omega 3 Strides Arcolab International omega-3-skābes etilesteri
Croatian: Hydroxyzine EQL Pharma hidroksizin
Latvian: Hydroxyzine EQL Pharma hidroksizīns
Croatian: 2care4 Generics ApS
Latvian: Zviedrija 2care4 Generics ApS
Croatian: Miofen ibuprofen
Latvian: Miofen ibuprofēns
Croatian: Medreich PLC Gliclazide 40 mg tablets gliklazid
Latvian: Medreich PLC Gliclazide 40 mg tablets gliklazīds
Croatian: Biogaran hydroxyzine BIOGARAN hidroksizin
Latvian: Francija Biogaran hydroxyzine BIOGARAN
Croatian: BBS Consult ApS Loperamid BBS
Latvian: BBS Consult ApS
Croatian: Španjolska Bluefish Pharmaceuticals AB
Latvian: Spānija Bluefish Pharmaceutical s AB
Croatian: Irbesartan 75 mg Filmcoated Tablets irbesartan
Latvian: Irbesartan 75 mg Film-coated Tablets irbesartāns
Croatian: Bupropion HCl Sandoz bupropion
Latvian: Bupropion HCl Sandoz bupropions
Croatian: Hydroxyzinhydrochlorid EQL Pharma hidroksizin
Latvian: Hydroxyzinhydrochlorid EQL Pharma hidroksizīns
Croatian: Orion Corporation, Finska
Latvian: Corporation, Finland
Croatian: Nizozemska Aurobindo Pharma B.V.
Latvian: Nīderlande Aurobindo Pharma B.V.
Croatian: perindopril/indapamid 8 mg/2,5 mg tableta
Latvian: perindoprils/indapamīds 8 mg/2,5 mg Tablete Iekšķīgai lietošana i
Croatian: Evolan Pharma AB Loperamid Evolan loperamid
Latvian: Loperamid Evolan loperamīds
Croatian: Beta-histina Basi
Latvian: Beta-histina Basi betahistīns
Croatian: Irbesartan HEC Pharm 75 mg Filmtabletten irbesartan
Latvian: Irbesartan HEC Pharm 75 mg Filmtabletten irbesartāns
Croatian: Betahistin - 1 A Pharma 24 mg Tabletten
Latvian: Betahistin - 1 A Pharma 24 mg Tabletten betahistīns
Croatian: Loperamid Apofri loperamid
Latvian: Apofri AB Loperamid Apofri loperamīds
Croatian: Levonorgestrel/Ethinylestr adiol Famy Care 125 mikrogramů/30 mikrogramů etinilestradiol/levonor gestrel
Latvian: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů etinilestradiols/levonorgestr els
Croatian: loperamid
Latvian: loperamīds
Croatian: Naproxeno Aurobindo naproksen
Latvian: Naproxen Aurobindo naproksēns
Croatian: Irbesartan HEC Pharm 300 mg Filmtabletten irbesartan
Latvian: Irbesartan HEC Pharm 300 mg Filmtabletten irbesartāns
Croatian: Gliclazide 40mg Tablets gliklazid
Latvian: Gliclazide 40 mg Tablets gliklazīds
Croatian: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 8 mg/2,5 mg tableta
Latvian: Francija ZYDUS France perindopril/Indapamide Zydus France perindoprils/indapamīds 8 mg/2,5 mg Tablete Iekšķīgai lietošana i
Croatian: 1A Pharma GmbH
Latvian: Austrija 1A Pharma GmbH
Croatian: Maexeni 30 0,03 mg/0,15 mg Filmtabletten etinilestradiol/levonor gestrel mg/0,15 mg neuraxpharm Arzneimittel GmbH
Latvian: Maexeni 30 0,03 mg/0,15 mg Filmtabletten etinilestradiols/levonorgestr els
Croatian: Vzole 50 mg film-coated tablets vorikonazol
Latvian: Vzole 50 mg film-coated tablets vorikonazols
Croatian: Gliclazide 80mg Tablets gliklazid
Latvian: Gliclazide 80 mg Tablets gliklazīds
Croatian: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter
Latvian: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropions
Croatian: Hydroxyzine Sandoz hidroksizin
Latvian: Hydroxyzine Sandoz hidroksizīns
Croatian: Vzole 200 mg film-coated tablets vorikonazol
Latvian: Vzole 200 mg film-coated tablets vorikonazols
Croatian: Amlodipin/Valsartan PUREN (u Njemačkoj)
Latvian: Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (Vācijā)
Croatian: Betahistin - 1 A Pharma 8 mg Tabletten
Latvian: Betahistin - 1 A Pharma 8 mg Tabletten betahistīns
Croatian: Maexeni 150/30 microgram Film Coated Tablets etinilestradiol/levonor gestrel mg/0,125 mg
Latvian: Maexeni 150/30 microgram Film Coated Tablets etinilestradiols/levonorgestr els
Croatian: Cristers
Latvian: Francija Cristers
Croatian: Beta-histina Sandoz
Latvian: Beta-histina Sandoz betahistīns
Croatian: Irbesartan HEC Pharm 150 mg Filmtabletten irbesartan
Latvian: Irbesartan HEC Pharm 150 mg Filmtabletten irbesartāns
Croatian: Irbesartan 300 mg Filmcoated tablets irbesartan
Latvian: Irbesartan 300 mg Film-coated tablets irbesartāns
Croatian: Hydroxyzine ARROW hidroksizin
Latvian: Hydroxyzine ARROW
Croatian: Betados 8 mg
Latvian: Betados 8 mg betahistīns
Croatian: Vasobex
Latvian: Vasobex betahistīns
Croatian: Naproxen 500 mg tablets naproksen
Latvian: Naproxen 500 mg tablets naproksēns
Croatian: Betahistin - 1 A Pharma 16 mg Tabletten
Latvian: Betahistin - 1 A Pharma 16 mg Tabletten betahistīns
Croatian: Irbesartan 150 mg Filmcoated tablets irbesartan
Latvian: Irbesartan 150 mg Film-coated tablets irbesartāns
Croatian: memantin
Latvian: memantīns
Croatian: Paracetamol 500 mg Film Coated Tablets paracetamol
Latvian: Paracetamol 500 mg Film Coated Tablets paracetamols
Croatian: Metformin 1000 mg Filmcoated tablet metformin hidroklorid 1 000 mg filmom obložena tableta
Latvian: Metformin 1000 mg Film-coated tablet metformīna hidrohlorīds 1000 mg
Croatian: ibuprofen
Latvian: ibuprofēns
Croatian: Voriconazol Glob vorikonazol
Latvian: Voriconazol Glob vorikonazols
Croatian: Hydroxyzine CRISTERS hidroksizin
Latvian: Hydroxyzine CRISTERS
Croatian: naproksen
Latvian: naproksēns
Croatian: Bupropion Sandoz bupropion
Latvian: Bupropion Sandoz bupropions
Croatian: Paracetamol 1000 mg Film Coated Tablets paracetamol
Latvian: Paracetamol 1000 mg Film Coated Tablets paracetamols
Croatian: Dawa Limited Carbimazole 5mg Tablets karbimazol
Latvian: Dawa Limited Carbimazole 5 mg Tablets karbimazols
Croatian: Betados 16 mg
Latvian: Betados 16 mg betahistīns
Croatian: Bupropion Sandoz 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion
Latvian: Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropions
Croatian: Naproxen Aurobindo 250 mg, tabletten naproksen
Latvian: Naproxen Aurobindo 250 mg, tabletten naproksēns
Croatian: Bupropione Sandoz bupropion
Latvian: Bupropione Sandoz bupropions
Croatian: Aurobindo Pharma BV
Latvian: Beļģija Aurobindo Pharma BV
Croatian: Carbimazole 5mg Tablets karbimazol
Latvian: Carbimazole 5 mg Tablets karbimazols
Croatian: Hydroxyzine ZENTIVA hidroksizin
Latvian: Hydroxyzine ZENTIVA
Croatian: Amlodipina + Valsartan Aurovitas,
Latvian: Amlodipina+Valsartan Aurovitas amlodipīns/valsartāns
Croatian: Metformin 850 mg Filmcoated tablet metformin hidroklorid 850 mg filmom obložena tableta
Latvian: Metformin 850 mg Film-coated tablet metformīna hidrohlorīds 850 mg
Croatian: etinilestradiol/levonor gestrel
Latvian: Ethinylestradiol/Levonorgeshel Famy Care
Croatian: Sandoz GmbH
Latvian: Slovēnija Sandoz GmbH
Croatian: Metformin 500 mg Filmcoated tablet metformin hidroklorid 500 mg filmom obložena tableta
Latvian: Metformin 500 mg Film-coated tablet metformīna hidrohlorīds 500 mg
Croatian: Paracetamol 1000mg Tablets paracetamol
Latvian: Paracetamol 1000 mg Tablets paracetamols
Croatian: Voriconazolo Aurobindo vorikonazol
Latvian: Voriconazolo Aurobindo vorikonazols
Croatian: Naproxen Aurobindo 500 mg, tabletten naproksen
Latvian: Naproxen Aurobindo 500 mg, tabletten naproksēns
Croatian: Voriconazol PUREN 200 mg Filmtabletten vorikonazol
Latvian: Voriconazol PUREN 200 mg Filmtabletten vorikonazols
Croatian: ELC Group s.r.o. Esters ethyliques d'acides omega-3 Strides etilni[90]esteri omega-3 kiselina
Latvian: Esters ethyliques d'acides omega-3 Strides omega-3-skābes etilesteri
Croatian: voriconazole Arrow vorikonazol
Latvian: voriconazole Arrow vorikonazols
Croatian: Histabal
Latvian: Histabal betahistīns
Croatian: Voriconazol PUREN 50 mg Filmtabletten vorikonazol
Latvian: Voriconazol PUREN 50 mg Filmtabletten vorikonazols
Croatian: Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonazol
Latvian: Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonazols
Croatian: Betahistin HEXAL 24 mg Tabletten
Latvian: Betahistin HEXAL 24 mg Tabletten betahistīns
Croatian: Paracetamol 500mg Tablets paracetamol
Latvian: Paracetamol 500 mg Tablets paracetamols
Croatian: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 4 mg/1,25 mg
Latvian: Francija ZYDUS France perindopril/Indapamide Zydus France perindoprils/indapamīds 4 mg/1,25 mg Tablete Iekšķīgai lietošana i
Croatian: Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazol
Latvian: Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazols
Croatian: Sandoz Gmbh
Latvian: Austrija Sandoz GmbH
Croatian: 84x1 Kapsula (jedinična doza)
Latvian: 84x1 kapsulas (vienības deva)
Croatian: 84 Kapsula
Latvian: 84 kapsulas
Croatian: Više informacija o lijeku Miglustat Dipharma dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Latvian: Sīkāka informācija par Miglustat Dipharma ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Croatian: To uključuje gubitak koordinacije, probleme u vezi sa „sakadnim" (brzim) pokretima očiju koji mogu dovesti do oštećenja vida, kašnjenja u razvoju, otežanog gutanja, smanjenog tonusa mišića, napadaja i poteškoća u učenju.
Latvian: Tie ir koordinācijas zudums, problēmas ar "sakādisko" (ātro) acu kustību, kas var izraisīt redzes traucējumus, palēnināta attīstība, apgrūtināta rīšana, samazināts muskuļu tonuss, krampji un mācīšanās grūtības.
Croatian: Preporučena početna doza za Gaucherovu bolest tipa 1 je kapsula tri puta dnevno.
Latvian: Ieteicamā sākumdeva 1. tipa Gošē slimības gadījumā ir viena kapsula trīsreiz dienā.
Croatian: Dva su lijeka bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari i stoga se očekuje da imaju isti učinak.
Latvian: Divas zāles ir bioekvivalentas, ja tās nodrošina vienādu aktīvās vielas līmeni organismā un līdz ar to ir sagaidāma vienāda to iedarbība.
Croatian: Miglustat Dipharma (miglustat)
Latvian: Miglustat Dipharma (miglustats)
Croatian: Pregled informacija posljednji je put ažuriran u 6. 2019.
Latvian: Šis kopsavilkums pēdējo reizi atjaunināts 2019. gada jūnijā.
Croatian: Lijek se izdaje samo na recept, a liječenje moraju nadzirati liječnici s iskustvom u liječenju Gaucherove bolesti.
Latvian: Zāles var iegādāties tikai pret recepti, un ārstēšana ir jāuzrauga ārstiem ar pieredzi Gošē slimības ārstēšanā.
Croatian: Miglustat Dipharma je „generički lijek".
Latvian: Miglustat Dipharma ir "ģenēriskas zāles".
Croatian: • odraslih osoba (u dobi od 18 godina i starijih) s blagim do umjerenim oblikom Gaucherove bolesti tipa 1.
Latvian: • pieaugušos (no 18 gadu vecuma) ar viegli līdz vidēji izteiktu 1. tipa Gošē slimību.
Croatian: Za NiemannPickovu bolest tipa C doza je dvije kapsule triput dnevno za bolesnike u dobi od 12 godina i starije, a u mlađih bolesnika doza ovisi o tjelesnoj težini i visini.
Latvian: C tipa Nīmaņa-Pika slimības gadījumā deva ir divas kapsulas trīsreiz dienā pacientiem no 12 gadu vecuma; jaunākiem pacientiem deva ir atkarīga no to svara un garuma.
Croatian: Miglustat Dipharma primjenjuje se za liječenje neuroloških simptoma bolesti (simptoma koji su povezani s mozgom i živcima).
Latvian: Miglustat Dipharma lieto, lai ārstētu slimības neiroloģiskos simptomus (simptomus, kuri ietekmē smadzenes un nervus).
Croatian: Nuspojave prijavljene za lijek Miglustat Dipharma pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Latvian: Ziņotās ar Miglustat Dipharma lietošanu saistītās blakusparādības tiek rūpīgi izvērtētas, un tiek veikti visi pacientu aizsardzībai nepieciešamie pasākumi.
Croatian: Lijek Miglustat Dipharma dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. veljače 2019.
Latvian: Miglustat Dipharma 2019. gada 18. februārī saņēma reģistrācijas apliecību, kas derīga visā ES.
Croatian: Miglustat Dipharma primjenjuje se u bolesnika koji ne mogu primati standardno liječenje enzimskom nadomjesnom terapijom (ERT);
Latvian: Miglustat Dipharma lieto pacientiem, kuri nevar saņemt standartterapiju fermenta aizstājterapijas (ERT) veidā;
Croatian: • u bolesnika svih dobi oboljelih od Niemann-Pickove bolesti tipa C, potencijalno smrtonosne bolesti tijekom koje se glikosfingolipidi nakupljaju u stanicama mozga i u drugim dijelovima tijela.
Latvian: • visu vecumu pacientus ar C tipa Nīmaņa-Pika slimību jeb potenciāli nāvējošu slimību, ar kuru saslimstot, glikosfingolipīdi uzkrājas smadzeņu šūnās vai kādā citā ķermeņa daļā.
Croatian: To znači da Miglustat Dipharma sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek" koji je već odobren u EU-u pod nazivom Zavesca.
Latvian: Tas nozīmē, ka Miglustat Dipharma satur to pašu aktīvo vielu un ir līdzīgas "atsauces zālēm", kas jau ir reģistrētas Eiropas Savienībā (ES) ar nosaukumu Zavesca.
Croatian: Miglustat Dipharma koristi se za liječenje dviju nasljednih bolesti koje utječu na način na koji tijelo prerađuje masti.
Latvian: Miglustat Dipharma lieto, lai ārstētu divas iedzimtās slimības, kas ietekmē veidu, kā organisms pārstrādā taukus.
Croatian: Za više informacija o primjeni lijeka Miglustat Dipharma pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Latvian: Papildu informāciju par Miglustat Dipharma lietošanu skatīt zāļu lietošanas instrukcijā vai jautāt ārstam vai farmaceitam.
Croatian: Što je Miglustat Dipharma i za što se koristi?
Latvian: Kas ir Miglustat Dipharma un kāpēc tās lieto?
Croatian: Miglustat Dipharma primjenjuje se za liječenje sljedećih bolesnika:
Latvian: Miglustat Dipharma lieto, lai ārstētu šādus pacientus: