FrancophonIA/ELRC3.0 huggingface dataset:
Romanian: RO - Romania NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429
Latvian: RO - Rumānija NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429
Romanian: AURORA PHARMACEUTICALS A.E. EVROU 4 & MESSINIAS 2 GERAKAS 15344
Latvian: EVROU 4 & MESSINIAS 2 GERAKAS 15344
Romanian: BIOMEDICA-CHEMICA S.A. G. LYRA 25
Latvian: BIOMEDICA-CHEMICA S.A.
Romanian: Gyömröi út, 19-21, H-1103 Budapest Hungria
Latvian: Gyömröi út, 19-21, H-1103
Romanian: PT - Portugalia Parke-Davis - Produtos Farmacêuticos, Lda.
Latvian: PT - Portugāle Parke-Davis - Produtos Farmacêuticos, Lda.
Romanian: Solutie injectabila
Latvian: Šķīdums injekcijām
Romanian: FI - Finlanda medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany
Latvian: FI - Somija medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany
Romanian: DE - Germania AWD.pharma GmbH & Co.KG Wasastr.
Latvian: AWD.pharma GmbH & Co.KG
Romanian: PT - Portugalia Almus, Lda.
Latvian: PT - Portugāle Almus, Lda.
Romanian: BG - Bulgaria Novartis Pharma GmbH, Roonstrasse 25, D-90429
Latvian: BG - Bulgārija Novartis Pharma GmbH, Roonstrasse 25, D-90429
Romanian: Mylan BV Dieselweg 25 3752 LB Bunschoten Netherlands
Latvian: 3752 LB Bunschoten Netherlands
Romanian: Forosa 70 mg filmsko obložene tablete
Latvian: Forosa 70 mg filmsko obložene tablete apvalkotā tablete
Romanian: Capsule tari
Latvian: Cietā kapsula
Romanian: DK - Danemarca medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg,
Latvian: DK - Dānija medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany
Romanian: 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Latvian: NL - Nīderlande Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom
Romanian: Alendronat Lek 70 mg filmsko obložene tablete
Latvian: Alendronat Lek 70 mg filmsko obložene tablete apvalkotā tablete
Romanian: 10237 Prague 10.
Latvian: 10237 Prague 10. Czech Republic
Romanian: DK - Danemarca Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118
Latvian: BG - Bulgārija Stada Arzneimittel AG, Stadastrasse 2-18, 61118
Romanian: PT - Portugalia Biara - Produtos Farmacêuticos, Lda.
Latvian: PT - Portugāle Biara - Produtos Farmacêuticos, Lda.
Romanian: DE - Germania betapharm Arzneimittel GmbH Kobelweg 95
Latvian: DE - Vācija betapharm Arzneimittel GmbH
Romanian: NO - Norvegia Mylan AB, Box 23033, 10435 Stockholm, Sweden
Latvian: NO - Norvēģija Mylan AB, Box 23033, 10435 Stockholm, Sweden
Romanian: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos
Latvian: ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos tabletes
Romanian: GEDEON RICHTER Gyömroi ut 19-21 1103 Budapest X
Latvian: GEDEON RICHTER Gyömroi ut 19-21 1103 Budapest X HONGRIE
Romanian: PT - Portugalia Farmoz - Sociedade Técnico Medicinal, S.A.
Latvian: PT - Portugāle Farmoz - Sociedade Técnico Medicinal, S.A.
Romanian: KERN PHARMA, S.L. Venus, 72.
Latvian: KERN PHARMA, S.L.
Romanian: 200MG/CAP Capsule tari
Latvian: 200MG/CAP Cietā kapsula
Romanian: PT - Portugalia Faribérica - Produtos Farmacêuticos, S.A.
Latvian: PT - Portugāle Faribérica - Produtos Farmacêuticos, S.A.
Romanian: 84-B, 1549-005 Lisboa
Latvian: Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal
Romanian: PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland
Latvian: PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32
Romanian: Warner Chilcott Nederland BV
Latvian: NL - Nīderlande Warner Chilcott Nederland BV
Romanian: z o.o.
Latvian: P.O.
Romanian: DE - Germania axios Pharma GmbH Hauptstr.
Latvian: DE - Vācija axios Pharma GmbH Hauptstr. 198
Romanian: Bonefos tablets 800 mg 800 mg
Latvian: Bonefos tablets 800 mg
Romanian: Przedsiębiorstwo Farmaceutyczne LEK-AM Sp.
Latvian: Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
Romanian: Ibandrónico Pharmakern
Latvian: Ácido Ibandrónico Pharmakern
Romanian: DE - Germania Orifarm Generixs A/S Energivej 15
Latvian: Orifarm Generixs A/S Energivej 15
Romanian: 35.00 mg Risedronate sodium (equivalent to 69,6 mg
Latvian: 35.00 mg Risedronate sodium (equivalent to 69,6 mg Risendronic acid)
Romanian: Biofarm Sp.
Latvian: Biofarm Sp. z o.o.
Romanian: ACIDO ALENDRONICO TEVA 70 mg comprimidos
Latvian: ACIDO ALENDRONICO TEVA 70 mg comprimidos tabletes
Romanian: DK - Danemarca Teva Denmark A/S, Parallelvej 10-12, DK-2800
Latvian: Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Romanian: AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden
Latvian: RO - Rumānija AVENTIS PHARMA AB Bryggvagen 16-18, 11768
Romanian: Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium
Latvian: NL - Nīderlande Ranbaxy Belgium NV Leuvensestraat 28b
Romanian: Alendrohexal 70 mgeinmal wöchentlich Filmtabletten
Latvian: Alendrohexal 70 mgeinmal wöchentlich Filmtabletten apvalkotā tablete
Romanian: 92,75 mg Pulbere si solvent pentru solutie perfuzabila
Latvian: 92,75 mg Pulveris infūziju šķīduma pagatavošanai
Romanian: PT - Portugalia Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Latvian: PT - Portugāle Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Romanian: PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom
Latvian: Vision House, Bedford Road, Petersfield, Hants, GU32
Romanian: DE - Germania HIKMA Farmaceutica (Portugal) S.A.
Latvian: HIKMA Farmaceutica (Portugal) S.A.
Romanian: Spa,Warwickshire CV31 3RW, UK
Latvian: Warwickshire, CV31 3RW United Kingdom
Romanian: PT - Portugalia Alter, S.A. Estrada Marco do GriloZemouto,
Latvian: Estrada Marco do GriloZemouto,
Romanian: PT - Portugalia Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Latvian: PT - Portugāle Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Romanian: UK - Marea Britanie Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK
Latvian: UK - Lielbritānija Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK
Romanian: NO - Norvegia Bayer AB Box 606 169 26 Solna
Latvian: NO - Norvēģija Bayer AB Box 606
Romanian: Risedronat STADA 35 mg 35 mg
Latvian: Risedronat STADA 35 mg
Romanian: NO - Norvegia Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Latvian: NO - Norvēģija Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054
Romanian: PNG GEROLYMATOS MEDICAL S.A. ASKLIPIOU 13
Latvian: PNG GEROLYMATOS MEDICAL S.A.
Romanian: LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern
Latvian: Frederic Mompou, 5 08960 Sant Just Desvern
Romanian: SE - Suedia sanofi-aventis AB Box 14142 167 14 Bromma Sweden
Latvian: SE - Zviedrija sanofi-aventis AB Box 14142
Romanian: PT - Portugalia Optimal Regulatory Solutions, S.L. Via Augusta, 59, 08006 Barcelona Espanha
Latvian: Via Augusta, 59, 08006 Barcelona Espanha
Romanian: PHARMAGENUS 70 mg comprimidos
Latvian: PHARMAGENUS 70 mg comprimidos tabletes
Romanian: Alendronic Acid Bluefish Once weekly 70 mg Tablets
Latvian: Alendronic Acid Bluefish Once weekly 70 mg Tablets tabletes
Romanian: Merck Sharp & Dohme Bulgaria
Latvian: BG - Bulgārija Merck Sharp & Dohme Bulgaria
Romanian: Intravenous use
Latvian: Šķīdums iekšķīgai lietošanai
Romanian: TERAPIA SA,Str.
Latvian: RO - Rumānija TERAPIA SA,Str.
Romanian: D-64283 Darmstadt
Latvian: Elisabethenstr. 34 D-64283 Darmstadt
Romanian: Hospira Benelux BVBA, Stallestraat 63
Latvian: NL - Nīderlande Hospira Benelux BVBA, Stallestraat 63
Romanian: UKabelovny 130 Dolni Mecholupy 102 37 Prague 10
Latvian: UKabelovny 130 Dolni Mecholupy 102 37 Prague 10 CZECH REPUBLIC
Romanian: GERVASI FARMACIA, S.L.Juan XXIII, 15-19
Latvian: GERVASI FARMACIA, S.L.Juan XXIII, 15-19 08950 Esplugues de Llobregat
Romanian: Los Reyes, Madrid E-28700
Latvian: Empresarial La Marina, 28700 San Sebastian De Los Reyes, Madrid E-28700
Romanian: H-1103 Budapest
Latvian: H-1103 Budapest Hungary
Romanian: Foksal St. 00-372 Warsaw, Poland
Latvian: 00-372 Warsaw, Poland
Romanian: PT - Portugalia Tecnimede - Sociedade Técnico-Medicinal, S.A.
Latvian: PT - Portugāle Tecnimede - Sociedade Técnico-Medicinal, S.A.
Romanian: 35.00 mg Risedronate sodium (equivalent to 32,5 mg
Latvian: 35.00 mg Risedronate sodium (equivalent to 32,5 mg Risendronic acid)
Romanian: MERCK SHARP & DOHME Ltd Hertford Road, Hoddesdon Hertfordshire EN119BU
Latvian: Hertford Road, Hoddesdon Hertfordshire EN119BU
Romanian: UK - Marea Britanie Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK
Latvian: UK - Lielbritānija Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK
Romanian: DK - Danemarca Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031
Latvian: Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands
Romanian: UK - Marea Britanie Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid once weekly
Latvian: UK - Lielbritānija Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom alendronic acid once weekly
Romanian: Sandoz A/S, C. F. Tietgens Boulevard 40, 5220
Latvian: F. Tietgens Boulevard 40, 5220
Romanian: Merck Sharp & Dohme B.V. Waarderweg 39
Latvian: SK - Slovākija Merck Sharp & Dohme B.V. Waarderweg 39
Romanian: PT - Portugalia Apotex Europe, B.V. Darwinweg 20
Latvian: NL - Nīderlande Apotex Europe BV Darwinweg 20
Romanian: 61,74 mg Pulbere si solvent pentru solutie perfuzabila
Latvian: 61,74 mg Pulveris infūziju šķīduma pagatavošanai
Romanian: Actonel Plus Ca & D 35mg film-coated tablet + 1000mg/800
Latvian: Actonel Plus Ca & D 35mg film-coated tablet + 1000mg/800 IU Effervescent Granules
Romanian: ROTTAPHARM SpA Via Galleria Unione,5
Latvian: ROTTAPHARM SpA Via Galleria Unione,5 20122 Milano (MI)
Romanian: Fostepor 10mg Tablets 10mg
Latvian: Fostepor 10mg Tablets 10mg tabletes
Romanian: NO - Norvegia Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Latvian: NO - Norvēģija Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220
Romanian: Merck Sharp & Dohme BV Waarderweg 39
Latvian: NL - Nīderlande Merck Sharp & Dohme BV Waarderweg 39
Romanian: BG - Bulgaria Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Latvian: BG - Bulgārija Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220,
Romanian: Fosalen 10 mg Tablets 10mg
Latvian: Fosalen 10 mg Tablets 10mg tabletes
Romanian: SANDOZ S.R.L. , Str. Livezeni nr. 7A, Târgu Mureş, România
Latvian: RO - Rumānija SANDOZ S.R.L. , Str. Livezeni nr.
Romanian: PT - Portugalia ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875
Latvian: Rua António Quadros, 9GEscritório 3 1600-875
Romanian: DK - Danemarca BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
Latvian: BMM Pharma AB, Blasieholmsgatan 2, SE11148 Stockholm, Sweden
Romanian: Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany
Latvian: NOVARTIS PHARMA GMBH 25, ROONSTRASSE D 90429 NUERNBERG
Romanian: ADELAN SEMANAL 70 mg Comprimidos
Latvian: ADELAN SEMANAL 70 mg Comprimidos tabletes
Romanian: Fosamax tablet 70mg 70mg
Latvian: Fosamax tablet 70mg 70mg tabletes
Romanian: Concentrat pentru solutie perfuzabila, 5 ml
Latvian: Koncentrāts infūziju šķīduma pagatavošanai, 5 ml
Romanian: DK - Danemarca LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266
Latvian: SK - Slovākija LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266
Romanian: Tchaikapharma 1172 Sofia 1 G. M. Dimitrov Blvd Sofia
Latvian: 1 G. M. Dimitrov Blvd Sofia
Romanian: House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K
Latvian: Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K
Romanian: PT - Portugalia Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Latvian: PT - Portugāle Laboratórios Basi - Indústria Farmacêutica, S.A.
Romanian: ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos
Latvian: ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos tabletes
Romanian: 84-B 1549-005 Lisboa,
Latvian: Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal
Romanian: Kwas alendronowy 70 mg Tabletka
Latvian: Kwas alendronowy 70 mg Tabletka tabletes
Romanian: Prin urmare, CHMP a considerat indicaţia ca fiind acceptabilă.
Latvian: Tādējādi CHMP uzskatīja indikāciju par pieņemamu.
Romanian: Conţinut (concentraţie)
Latvian: Saturs (koncentrācij a)
Romanian: CHMP a evaluat datele disponibile pentru a stabili dacă cele două indicaţii pot fi susţinute.
Latvian: CHMP novērtēja pieejamos datus, lai varētu konstatēt, vai šīs divas indikācijas ir jāatbalsta.
Romanian: ANEXA II CONCLUZII ŞTIINŢIFICE
Latvian: PIELIKUMS II ZINĀTNISKIE SECINĀJUMI
Romanian: Deşi solicitantul a fost de acord să elimine indicaţiile contestate de către statul membru care a obiectat, statul membru de referinţă şi celelalte state membre pozitive au fost în favoarea păstrării acestor indicaţii.
Latvian: Lai gan iesniedzējs piekrita dzēst indikācijas, pret kurām iebilda ieinteresētā dalībvalsts, atsauces dalībvalsts un citas pozitīvi ieinteresētās dalībvalstis vēlējās saglabāt šīs indikācijas.
Romanian: injectabilă
Latvian: injekcijas
Romanian: MOTIVELE AVIZULUI
Latvian: VIEDOKĻA PAMATOJUMS
Romanian: În concluzie, CHMP a considerat că această eficacitate depăşeşte toxicitatea produsului şi că raportul beneficiu/risc este pozitiv.
Latvian: Nobeigumā CHMP secināja, ka šis iedarbīgums atsver zāļu toksicitāti un ka ieguvuma un riska līdzsvars ir pozitīvs.
Romanian: CHMP a remarcat că bleomicina este utilizată clinic din anii 1960, explicând astfel lipsa unui program de dezvoltare clinică.
Latvian: CHMP atzīmēja, ka kopš 1960-tajiem gadiem bleomicīns tiek klīniski izmantots, tādējādi izskaidrojot klīniskās izstrādes programmas neesamību.
Romanian: REZUMATUL GENERAL AL EVALUĂRII ŞTIINŢIFICE PENTRU BLEOMYCIN PHARMACHEMIE ŞI DENUMIRILE ASOCIATE (VEZI ANEXA I)
Latvian: BLEOMYCIN PHARMACHEMIE UN RADNIECĪGO NOSAUKUMU ZĀĻU ZINĀTNISKĀ NOVĒRTĒJUMA VISPĀRĒJS KOPSAVILKUMS (SKATĪT I PIELIKUMU)
Romanian: Cererea pentru Bleomycin Pharmachemie a fost înaintată ca o cerere generică bazată pe autorizaţia de introducere pe piaţă acordată pentru produsul de referinţă în Ţările de Jos la data de 18 noiembrie 1997.
Latvian: Iesniegums zālēm Bleomycin Pharmachemie tika iesniegts kā ģenērisku zāļu iesniegums, pamatojoties uz reģistrācijas apliecību, kas izsniegta atsauces zālēm Nīderlandē 1997. gada 18. novembrī.
Romanian: Deoarece nu s-a putut ajunge la un consens, Grupul de coordonare pentru proceduri descentralizate şi de recunoaştere reciprocă (uz uman) a înaintat procedura Comitetului pentru produse medicamentoase de uz uman.
Latvian: Tā kā nevarēja panākt vienprātību, savstarpējās atzīšanas un decentralizēto procedūru koordinācijas grupa cilvēkiem paredzēto zāļu jautājumos nodeva šo procedūru cilvēkiem paredzēto zāļu komitejai (CHMP).
Romanian: Administrarea de bleomicină se realizează, aproape întotdeauna, în combinaţie cu alte medicamente citostatice şi/sau cu radioterapia.
Latvian: Gandrīz vienmēr bleomicīns tiek lietots kopā ar citām citostatiskām zālēm un/vai radiācijas terapiju.
Romanian: În Ţările de Jos, bleomicina este în prezent aprobată pentru următoarele indicaţii:
Latvian: Pašlaik Nīderlandē zāles bleomicīns ir apstiprinātas šādām indikācijām:
Romanian: ANEXA I LISTA CU DENUMIRILE COMERCIALE, FORMA FARMACEUTICĂ, CONCENTRAŢIA MEDICAMENTULUI, CĂILE DE ADMINISTRARE, SOLICITANŢII IN STATELE MEMBRE
Latvian: PIELIKUMS I ZĀĻU NOSAUKUMU, ZĀĻU FORMU, STIPRUMA SARAKSTS, IEVADĪŠANAS VEIDI, PIETEIKUMU IESNIEDZĒJI DALĪBVALSTĪS
Romanian: Într-o mai mică măsură, bleomicina influenţează de asemenea sinteza de ARN şi proteine.
Latvian: Mazākā apjomā bleomicīns ietekmē arī RNS un proteīnu sintēzi.
Romanian: Statul membru UE/SEE
Latvian: ES/EEZ Dalībvalsts
Romanian: Aşadar, CHMP este de părere că bleomicina este încă un medicament chimioterapeutic valoros şi a adoptat toate indicaţiile propuse pentru Bleomycin Pharmachemie:
Latvian: Tādēļ CHMP uzskata, ka bleomicīns joprojām ir vērtīgas ķīmijterapijas zāles, un apstiprināja visas ierosinātās indikācijas zālēm Bleomycin Pharmachemie:
Romanian: De asemenea, CHMP a observat că bleomicina este încă utilizată şi menţionată în ghidurile terapeutice curente din Europa şi America de Nord, cum ar fi carcinomul cu celule scuamoase al capului şi gâtului: Practice Guidelines in Oncology-v.2.2008 (Instrucţiuni de practică în oncologie-v.2.2008) (HCCN, SUA), CCO (Cancer Care Ontario) Formulary (Formularul CCO (Cancer Care Ontario)), revizuit în 2006/2007 şi Guidelines on penile cancer (Instrucţiuni privind cancerul penian) (martie 2004) ale Asociaţiei Europene de Urologie.
Latvian: CHMP atzīmēja arī to, ka bleomicīnu joprojām izmanto un ka tas ir arī minēts Eiropas un Ziemeļamerikas pašreizējās ārstēšanas vadlīnijās, piemēram, SCCHN: Praktiskas vadlīnijas onkoloģijā-2008. g. 2.sējums (Practice Guidelines in Oncology-v.2.2008) (HCCN, ASV), CCO (Cancer Care Ontario) rokasgrāmatas 2006/2007. gada redakcija, un Eiropas Urologu asociācijas vadlīnijās par dzimumlocekļa vēzi (2004. gada marts) (Guidelines on penile cancer (March 2004) of the European Association of Urology).
Romanian: Deoarece evaluarea raportului beneficiu/risc pentru aceste indicaţii a fost negativă pentru produsul original şi pentru că indicaţiile au fost, în consecinţă, şterse din indicaţiile autorizate pentru toate produsele care conţin bleomicină din Germania, acestea au fost privite ca fiind indicaţii noi şi statul membru care a obiectat a considerat că datele înaintate sunt insuficiente pentru acordarea autorizaţiei de introducere pe piaţă pentru noile indicaţii propuse.
Latvian: Tā kā šo indikāciju priekšrocību/risku novērtējums bija negatīvs oriģinālajām zālēm un tā kā šīs indikācijas tika dzēstas no apstiprināto indikāciju saraksta visām bleomicīnu saturošam zālēm Vācijā, šīs indikācijas tika uzskatītas par jaunām indikācijām, un dalībvalsts, kas iebilda, uzskatīja, ka iesniegtie dati nebija pietiekami, lai izsniegtu reģistrācijas apliecību ieteiktajām jaunajām indikācijām.
Romanian: Acelaşi lucru se aplică şi pentru indicaţia de cancer penian; indicaţia este susţinută de rapoarte care sugerează o eficacitate modestă pentru această boală.
Latvian: Tas pats ir attiecināms uz indikāciju par dzimumlocekļa vēzi - indikācija tiek atbalstīta pārskatos, kuros minēts neliels iedarbīgums uz šo slimību.
Romanian: Aşadar, în ciuda toxicităţii clare şi a eficacităţii modeste, CHMP a considerat că bleomicina este o opţiune valoroasă de tratament pentru tratamentul sistemic, dacă este considerată a fi necesară pentru aceste indicaţii.
Latvian: Tādēļ, neskatoties uz acīmredzamo toksicitāti un nelielo iedarbīgumu, CHMP uzskatīja, ka bleomicīns ir vērtīga ārstēšanas iespēja sistēmiskajā terapijā, ja tas tiek uzskatīts par nepieciešamu šīm indikācijām.
Romanian: Rezumatul caracteristicilor produsului, etichetarea şi prospectul valide reprezintă versiunile finale obţinute în timpul procedurii grupului de coordonare.
Latvian: Spēkā esošais zāļu apraksts, markējuma teksts un lietošanas instrukcija ir to pēdējais variants, kas iegūts Koordinācijas grupu procedūras laikā.
Romanian: Solicitant
Latvian: Pieteikuma iesniedzējs
Romanian: În tratamentul combinat, bleomicina este de asemenea valoroasă, deşi dovezile contribuţiei exclusive a bleomicinei nu pot fi evaluate.
Latvian: Arī kombinācijas terapijā bleomicīns ir vērtīgs, lai gan bleomicīna atsevišķa ieguldījuma pierādījumi nav novērtējami.
Romanian: În ceea ce priveşte indicaţia pentru cancerul localizat la cap şi gât, CHMP este de părere că, deşi bleomicina prezintă în mod evident dezavantaje cu privire la toxicitatea sa (pulmonită, fibroză pulmonară, stomatită şi modificări cutanate), bleomicina mai are încă un rol (neoadjuvant) în tratamentul bolii.
Latvian: Attiecībā uz indikāciju par galvas un kakla vēzi, CHMP uzskata, ka, lai gan bleomicīnam ir acīmredzamas nepilnības saistībā ar tā toksicitāti (pulmonīts, plaušu fibroze, stomatīts un ādas izmaiņas), bleomicīnam joprojām ir sava loma slimību (neoadjuvantā) terapijā.
Romanian: Întrucât - riscurile observate de toxicitate sunt depăşite de eficacitatea stabilită a bleomicinei, - eficacitatea bleomicinei poate fi considerată ca şi stabilită prin literatura publicată şi ghidurile terapeutice curente din Europa şi America de Nord - şi ţinând cont de utilizarea terapeutică curentă a bleomicinei, CHMP recomandă acordarea autorizaţiilor de introducere pe piaţă ale căror rezumate ale caracteristicilor produsului, etichetare şi prospecte rămân ca versiuni finale convenite în timpul procedurii grupului de coordonare, aşa cum se menţionează în anexa III pentru Bleomycin Pharmachemie şi denumirile asociate (vezi anexa I).
Latvian: Tā kā - bleomicīna izveidotais iedarbīgums ir pārāks par novērotās toksicitātes riskiem, - bleomicīna iedarbīgumu var uzskatīt par izveidotu, pamatojoties uz publicēto literatūru un Eiropas un Ziemeļamerikas pašreizējām ārstēšanas vadlīnijām, - un ņemot vērā bleomicīna pašreizējo terapeitisko pielietojumu, CHMP ir ieteikusi izsniegt zāļu reģistrācijas apliecības, attiecībā uz kurām zāļu apraksts, marķējums un lietošanas pamācība paliek spēkā saskaņā ar galējo versiju, kas noteikta koordinācijas grupas procesa laikā, kā minēts III pielikumā zālēm Bleomycin Pharmachemie un to radniecīgajiem nosaukumiem (skatīt I pielikumu).
Romanian: Efectul bleomicinei se datorează intercalării cu lanţurile simple sau duble de ADN, determinând rupturi ale lanţului simplu sau dublu, inhibând astfel diviziunea celulară, creşterea şi sinteza de ADN.
Latvian: Bleomicīna iedarbība balstās uz interkalāciju ar DNS vienu un divām virknēm, kas izraisa vienas un divu virkņu pārrāvumu, kas savukārt kavē šūnu dalīšanos, attīstību un DNS sintēzi.
Romanian: CHMP a considerat că, deşi bleomicina nu este o componentă evidentă de primă linie a tratamentului sistemic pentru cancerul cervical, bleomicina rămâne un medicament citostatic util care trebuie să rămână disponibil pacienţilor cu această indicaţie.
Latvian: CHMP uzskatīja, ka, lai gan bleomicīns nebūt nav pirmās kārtas komponents dzemdes kakla vēža sistēmiskā terapijā, bleomicīns ir noderīgas citostatiskas zāles, kurām ir jābūt pieejamām pacientiem ar šādu indikāciju.
Romanian: Pe lângă documentaţia furnizată deja în timpul procedurii descentralizate, care susţine un rol modest dar sigur al bleomicinei în tratamentul carcinomului cu celule scuamoase al capului şi gâtului, un număr de rapoarte recente sprijină rolul bleomicinei în combinaţie cu alte fracţiuni chimioterapeutice, identificând atât rata de recuperare (RR) de 34% în timpul tratamentului de a doua linie, cât şi îmbunătăţirea controlului locoregional şi supravieţuirea pacienţilor cu cancer avansat localizat la cap şi gât în timpul tratamentului radioterapeutic şi chimioterapeutic postoperator concomitent cu mitomicina C şi bleomicină.
Latvian: Papildus decentralizētā procesa laikā jau iesniegtajai dokumentācijai, atbalstot pieticīgu, bet tai pat laikā noteiktu bleomicīna lomu SCCHN ārstēšanā, vairākos jaunākajos pārskatos ir norādīta bleomicīna loma savienojumā ar citām ķīmijterapijas daļām, norādot gan 34% atveseļošanās koeficientu (AK) otrās kārtas terapijā, gan lokālās kontroles uzlabojumu un pacientu izdzīvošanu ar progresējošo galvas un kakla vēzi, līdztekus pielietojot pēc operācijas radioterapiju un ķīmijterapiju ar mitomicīnu C un bleomicīnu.
Romanian: Bleomicina aparţine antibioticelor citostatice: este un amestec de antibiotice glicopeptidice, alcaline, hidrosolubile, relaţionate structural, cu efect citostatic.
Latvian: Zāles bleomicīns ietilpst citostatisku antibiotiku grupā: tās ir strukturāli radniecīgas, sārmainas, ūdenī šķīstošas glikopeptīda antibiotikas ar citostatisku iedarbību.
Romanian: Mai mult, dificultatea de evaluare a eficacităţii de bază a bleomicinei atunci când rezultatele sunt obţinute prin regimuri combinate este recunoscută, totuşi eficacitatea totală favorabilă a regimurilor care conţin bleomicină sprijină indicaţia pentru bleomicină.
Latvian: Turklāt ir atzītas grūtības novērtēt bleomicīna atsevišķo iedarbīgumu, ja rezultāti tiek iegūti ar kombināciju ārstēšanas shēmu, tomēr vispārējais labvēlīgais bleomicīnu saturošu ārstēšanas shēmu iedarbīgums atbalsta bleomicīna indikāciju.