natgillin/translations-raw huggingface dataset:
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP..
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation, and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any a greed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP .
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP .
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in intervence, podrobno opisane v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the required pharmacovigilance activities and intervetions detailed in the agreedRMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform therequired pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall provide a Dear Healthcare Professional Letter (DHPC) and patient communication prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and, where required, all pharmacists who are expected to dispense Humalog.
Imetnik dovoljenja za promet z zdravilom bo pred dajanjem na trg oblikoval neposredno obvestilo zdravstvenim delavcem (DHPC) in informacije za bolnike, ki bodo posredovani vsem zdravnikom in medicinskim sestram, za katere se pričakuje, da bodo vključeni v zdravljenje in obravnavo bolnikov s sladkorno boleznijo ter, po potrebi, vsem farmacevtom, za katere se pričakuje, da bodo izdajali zdravilo Humalog.
The MAH shall provide a Dear Healthcare Professional Letter (DHPC) and patient communication prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and, where required, all pharmacists who are expected to dispense Liprolog.
Imetnik dovoljenja za promet z zdravilom bo pred dajanjem na trg oblikoval neposredno obvestilo zdravstvenim delavcem (DHPC) in informacije za bolnike, ki bodo posredovani vsem zdravnikom in medicinskim sestram, za katere se pričakuje, da bodo vključeni v zdravljenje in obravnavo bolnikov s sladkorno boleznijo ter, po potrebi, vsem farmacevtom, za katere se pričakuje, da bodo izdajali zdravilo Liprolog.
The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Imetnik dovoljenja za promet z zdravilom bo za vsako terapevtsko indikacijo pripravil izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali Pradaxo.
The MAH shall provide an educational pack prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and all pharmacists who are expected to dispense Tresiba.
Imetnik dovoljenja za promet bo pred prihodom zdravila na trg zagotovil izobraževalno gradivo, namenjeno vsem zdravnikom in medicinskim sestram, ki bodo predvidoma vključeni v zdravljenje in vodenje sladkornih bolnikov, in vsem farmacevtom, ki bodo predvidoma izdajali zdravilo Tresiba.
The MAH shall provide an educational pack prior to launch, targeting all physicians who are expected to prescribe/use Eliquis.
Imetnik dovoljenja za promet z zdravilom mora pred prihodom na trg zagotoviti paket izobraževalnega gradiva za vse zdravnike, ki bodo predvidoma predpisovali in/ali uporabljali zdravilo Eliquis.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti izobraževalno gradivo, namenjeno vsem zdravnikom, za katere se pričakuje, da bodo predpisovali/uporabljali pioglitazon.
The MAH shall provide physicians upon their request with free anti-erythropoietin antibody testing.
Imetnik dovoljenja za promet mora na zahtevo zdravnika zagotoviti brezplačno testiranje statusa protiteles.
The MAH shall provide the 1 year data report on a randomized, double-blind placebo- controlled large safety study, based on a protocol agreed with CHMP.
Imetnik dovoljenja za promet bo na podlagi protokola, dogovorjenega s CHMP, pripravil 1-letno poročilo o randomizirani, dvojno slepi, s placebom kontrolirani, obsežni študiji o varnosti.
The MAH shall report on the implementation of these measures by 16 December 2013 in the context of the PSUR.
Imetnik dovoljenja za promet z zdravilom mora v okviru PSUR poročati o uvedbi teh ukrepov do 16. decembra 2013.
The MAH shall send annually to prescribers and pharmacists who prescribe/dispense eculizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on eculizumab.
Imetnik dovoljenja za promet z zdravilom mora zdravnikom, ki predpisujejo zdravilo, in farmacevtom, ki izdajajo ekulizumab, pošiljati letne opomnike z namenom, da bo zdravnik, ki zdravilo predpisuje/farmacevt preveril, ali obstaja potreba po cepljenju/ponovnem cepljenju proti bakteriji Neisseria meningitidis svojih bolnikov, ki se zdravijo z ekulizumabom.
The MAH shall set up a disease registry to collect information on the epidemiology of the disease and the demographics, safety and effectiveness outcomes of patients with familial LPLD treated with Glybera.
Imetnik dovoljenja za promet z zdravilom bo vzpostavil register bolezni, s katerim bo zbiral podatke o epidemiologiji bolezni in izidih glede demografije, varnosti ter učinkovitosti pri bolnikih z družinskim LPLD, ki so se zdravili z zdravilom Glybera.
The MAH shall set up a post-authorisation safety study (PASS) in the form of an observational registry in order to collect information on demographics of patients prescribed Esbriet and suspected adverse drug reactions (ADRs).
Imetnik dovoljenja za promet z zdravilom mora pripraviti varnostno študijo po izdaji dovoljenja za promet z zdravilom v obliki opazovalnega registra, v katerem bodo zbrani demografski podatki o bolnikih, ki so jemali Esbriet, in možnih neželenih učinkih.
The MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed STAYVEER to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Imetnik dovoljenja za promet z zdravilom bo vzpostavil program/register nadzora za zbiranje informacij o demografskih in varnostnih podatkih ter podatkih o izidu za bolnike, ki jim je bilo zdravilo STAYVEER predpisano za zmanjšanje števila novih razjed prstov pri bolnikih s sistemsko sklerozo in potekajočo boleznijo razjed prstov.
The MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed Tracleer to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Imetnik dovoljenja za promet z zdravilom bo vzpostavil program/register nadzora za zbiranje informacij o demografskih in varnostnih podatkih ter podatkih o izidu za bolnike, ki jim je bilo zdravilo Tracleer predpisano za zmanjšanje števila novih razjed prstov pri bolnikih s sistemsko sklerozo in potekajočo boleznijo razjed prstov.
The MAH shall submit an updated RMP by 16.12.2013.
2013 predložil posodobljen RMP.
The MAH shall submit the results of a Phase II safety study investigating the benefits of the new deferasirox formulation (film-coated tablet) in comparison to the commercially approved dispersible tablet.
Imetnik dovoljenja za promet z zdravilom bo predložil rezultate varnostne študije faze II, v kateri so raziskovali prednosti nove formulacije deferasiroksa (filmsko obloženih tablet) v primerjavi s komercialno odobreno formulacijo disperzibilnih tablet.
The MAH shall use distinct outer cartons, blisters and tablets for both formulations (dispersible and film-coated tablet).
Imetnik dovoljenja za promet z zdravilom mora za vsako od obeh formulacij zdravila (disperzibilne tablete in filmsko obložene tablete) pripraviti drugačno zunanjo ovojnino (škatlo) ter drugačne pretisne omote in tablete.
The MAH shall, within each annual reassessment, provide yearly interim reports from the established registry in patients with congenital chronic cholestasis or hereditary cholestasis.
Imetnik dovoljenja za promet z zdravilom bo v vsakoletni ponovni oceni predložil letna vmesna poročila za ustanovljen register bolnikov s prirojeno kronično holestazo ali dedno holestazo.
The MAH should agree on the implementation of the patient card system in each Member State.
Imetnik dovoljenja za promet z zdravili se mora dogovoriti o izvajanju sistema kartic bolnika v vsaki državi članici.
The MAH should agree on the implementation of the patient card system in each Member State.
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti o izvajanju sistema kartic bolnika v vsaki državi članici.
The MAH should agree on the implementation of the patient card system in each Member State.
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti o izvajanju sistema kartic bolnikov v vsaki državi članici.
The MAH should agree the educational material with the Member States, prior to launch.
Imetnik dovoljenja za promet z zdravilom se bo pred začetkom prodaje z državo članico dogovoril za izobraževalno gradivo.
The MAH should agree the final content, format and distribution modalities of the Prescriber checklist and the Administration and monitoring guide with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet se bo z nacionalnimi pristojnimi organi v pristojnih državah članicah dogovoril o končni verziji, obliki in načinu distribucije Seznama za preverjanje ob predpisovanju in Priročnika o uporabi zdravila in spremljanju bolnikov ter zagotovil, da bo gradivo vsebovalo ključne elemente, kot so opisani spodaj.
The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional’s Kit with the National Competent Authority in each Member State prior to marketing of the product and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravilom se mora pred začetkom dajanja zdravila v promet dogovoriti s pristojnim nacionalnim organom v vsaki državi članici o končnem besedilu Pisma za zdravstvene delavce in vsebini izobraževalnega paketa za zdravstvene delavce in zagotoviti, da gradiva vsebujejo ključne elemente, kot je opisano spodaj.
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravili se mora dogovoriti s pristojnimi nacionalnimi organi v vsaki državi članici o končnem besedilu Neposrednega obvestila zdravstvenim delavcem in vsebinah paketa s podatki za zdravnike in zagotoviti, da gradiva vsebujejo ključne elemente, kot so opisane spodaj.
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti s pristojnimi nacionalnimi organi v vsaki državi članici o končnem besedilu Neposrednega obvestila zdravstvenim delavcem in vsebini paketa s podatki za zdravnike in zagotoviti, da gradiva vsebujejo ključne elemente, kot so opisani spodaj.
The MAH should aim to provide all HCPs who are are expected to prescribe Ruconest with the educational pack within one month after approval by the NCA.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da so vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Ruconest, prejeli izobraževalno gradivo v enem mesecu po odobritvi s strani pristojnega nacionalnega organa.
The MAH should also agree with each Member State prior to the launch of the product:
Imetnik dovoljenja za promet z zdravilom se mora prav tako v vsaki državi članici pred uvedbo zdravila na trg dogovoriti o:
The MAH should conduct a multicentre, randomized, open-label, Phase 2a study of Strensiq in patients with hypophosphatasia (HPP) to:
MAH bo opravil multicentrično, randomizirano, odprto študijo faze 2a zdravila Strensiq pri bolnikih s hipofosfatazijo (HPP) z naslednjima ciljema:
The MAH should conduct and submit results of a multicentre, randomised, double-
Imetnik dovoljenja za promet z zdravilom mora opraviti multicentrično,
The MAH should continue to submit yearly PSURs, until otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom (MAH) mora še naprej vsako leto predložiti oceno rednih posodobljenih poročil o varnosti zdravila (PSUR), dokler odbor CHMP ne določi drugače.
The MAH should distribute in Member States where Thalidomide Celgene is in use a Direct Healthcare Professional Communication letter informing healthcare professionals of the risk of second primary malignancies (SPM) in patients treated with Thalidomide Celgene, in accordance with its communication plan.
Imetnik dovoljenja za promet z zdravilom mora v državah članicah, kjer se zdravilo Thalidomide Celgene uporablja, razposlati neposredno obvestilo zdravstvenim delavcem, v katerem zdravstvene delavce obvešča o tveganjih drugih primarnih malignosti pri bolnikih, zdravljenih z zdravilom Thalidomide Celgene, v skladu z načrtom obveščanja.
The MAH should ensure that the educational materials are provided to and reviewed by the national patients’ organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se izobraževalno gradivo zagotovijo nacionalnim organizacijam za bolnike, da jih pregledajo, oziroma če te ne obstajajo ali če ne morejo sodelovati, zadevnim skupinam bolnikov.
The MAH should extend the studies ENB-008-10 and ENB-009-10 to provide efficacy data (such as, but not limited to RGI-C scores, height and weight change, biomarkers measurement) in patients 13 to 18 year-old of age.
MAH bo razširil študiji ENB-008-10 in ENB-009-10, da bo priskrbel podatke o učinkovitosti (med drugim, ne pa samo o rezultatih RGI-C, spremembi telesne višine in mase, merjenju bioloških označevalcev) pri bolnikih, starih 13 do 18 let.
The MAH should follow up patients in the existing Expanded Access Programme and submit the final results.
Imetnik dovoljenja za promet z zdravilom mora pri bolnikih v obstoječem programu razširjenega dostopa izvajati sledenje in predložiti končne rezultate.
The MAH should further investigate the efficacy and safety of Bronchitol in children and adolescents with cystic fibrosis.
Imetnik dovoljenja za promet z zdravilom mora dodatno raziskati učinkovitost in varnost zdravila Bronchitol pri otrocih in mladostnikih s cistično fibrozo.
The MAH should provide an inventory of all valuable
Imetnik dovoljenja za promet mora posredovati seznam
The MAH should provide tabulated data to the CHMP every
Imetnik dovoljenja za promet z zdravilom
The MAH should submit the final results of this study.
Imetnik dovoljenja za promet z zdravilom mora predložiti končne rezultate te študije
The MAH should submit the preliminary results of Study 20120325 (a phase 2, multicentre, open-label, single-arm trial to evaluate the correlation between objective response rate and baseline intratumoral CD8+T-lymphocyte density in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene laherparepvec)
Imetnik dovoljenja za promet mora predložiti preliminarne rezultate študije 20120325 (multicentrične, odprte študije faze II z eno samo skupino za oceno povezave med celotnim deležem odziva in izhodiščno gostoto intratumoralnih limfocitov CD8+T pri bolnikih z inoperabilnim melanomom stopenj IIIB do IVM1c, zdravljenih s talimogenom laherparepvekom).
The MAH should undertake a controlled distribution of NexoBrid to ensure that the product is not available for use at a centre until at least one surgeon at the centre has received formal training in the use of NexoBrid.
Imetnik dovoljenja za promet z zdravilom bo zdravilo NexoBrid distribuiral nadzirano, da zagotovi, da v centru ne bo na voljo, dokler vsaj en kirurg iz tega centra ne opravi formalnega izobraževanja o uporabi zdravila NexoBrid.