natgillin/translations-raw huggingface dataset:
The MAH shall ensure that in each MS where DARZALEX (daratumumab) is marketed, all HCPs and patients who are expected to prescribe, dispense and receive this product have access to/are provided with the below.
Imetnik bo zagotovil, da imajo v vsaki državi članici, v kateri je zdravilo DARZALEX (daratumumab) na trgu, vsi zdravstveni delavci in bolniki, ki bodo lahko predpisali, izdali ali prejeli to zdravilo, dostop do oziroma so prejeli:
The MAH shall ensure that in each MS where Myclausen is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myclausen are provided with the following educational package:
Imetnik dovoljenja za promet mora zagotoviti, da v vseh državah članicah, kjer je zdravilo Myclausen na tržišču, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo Myclausen, prejeli naslednja izobraževalna gradiva:
The MAH shall ensure that in parallel to the launch of Kadcyla, all health care professionals who may prescribe, dispense or administer Kadcyla and/or Herceptin are provided with a health care professional (HCP) educational pack.
Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila Kadcyla na trg, vsi zdravstveni delavci, ki lahko predpišejo, izdajo ali aplicirajo zdravilo Kadcyla in/ali zdravilo Herceptin dobijo izobraževalno gradivo za zdravstvene delavce.
The MAH shall ensure that information regarding all safety concerns identified in the most recent version of the Risk Management Plan is being collected.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da se zberejo podatki o vseh težavah, ki se ugotovijo v najnovejši različici načrta za obvladovanje tveganja.
The MAH shall ensure that prior to prescribing of the product prescribers will receive the prescriber checklist and the Administration and monitoring guide.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo predpisovalci, še pred začetkom predpisovanja zdravila, dobili seznam za preverjanje ob predpisovanju in Priročnik o uporabi zdravila in spremljanju bolnikov.
The MAH shall ensure that the Educational programme is implemented for currently authorised indications.
Imetnik dovoljenja za promet mora zagotoviti izvedbo izobraževalnega programa za trenutno odobrene indikacije.
The MAH shall ensure that, at launch and after launch, neurologists, ophthalmologists and other healthcare professionals (according to national requirements) are provided with a physician information pack containing the following elements:
Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila na trg in po prihodu zdravila na trg, nevrologi, oftalmologi in drugi zdravstveni delavci (skladno z nacionalnimi zahtevami), prejmejo izobraževalno gradivo za zdravnike, ki vključuje naslednje elemente:
The MAH shall ensure that, at launch and thereafter, all prescribers of Esmya and pathologists who review samples from Esmya-treated patients are provided with educational material.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je ob prihodu zdravila na trg in ves čas trženja zdravila vsem zdravnikom, ki predpisujejo zdravilo Esmya, in patologom, ki pregledujejo vzorce bolnikov, ki se zdravijo z zdravilom Esmya, na voljo izobraževalni material.
The MAH shall ensure that, at launch, in each Member State where EXJADE is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use EXJADE are provided with the following educational package for both formulations and on all indications:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, v kateri bo tržil zdravilo EXJADE, ob prihodu zdravila na tržišče vsi zdravstveni delavci in bolniki, ki bodo lahko predpisovali, razdeljevali ali uporabljali zdravilo EXJADE, prejeli enega od naslednjih kompletov izobraževalnega gradiva z informacijami za obe formulaciji zdravila in za vse indikacije:
The MAH shall ensure that, at the time of the European Commission decision for this procedure (EMEA/H/C/000898/A20/0018), all users of the spray application of this product are provided with educational material.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v času pridobitve dovoljenja za promet z zdravilom Evropske komisije (EMEA/H/C/000898/A20/0018) vsi uporabniki tega pršilnika prejeli izobraževani material.
The MAH shall ensure that, following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom zagotovi, da imajo vsi zdravniki, ki nameravajo predpisovati zdravilo LEMTRADA, po dogovoru z nacionalnimi pristojnimi organi v vsaki državi članici, kjer se trži zdravilo LEMTRADA, pred in po začetku trženja dostop do posodobljenega izobraževalnega paketa za zdravnike, ki vsebuje naslednje elemente:
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Aubagio is marketed, at launch and after launch, all healthcare professionals who are expected to use Aubagio are provided with the following items:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo po razpravi in v dogovoru s pristojnimi nacionalnimi organi v vsaki državi članici, kjer se zdravilo Aubagio trži, ob prihodu zdravila na trg in potem, vsi zdravstveni delavci, ki nameravajo predpisovati zdravilo Aubagio, prejeli naslednje:
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where NEURACEQ is marketed, at launch and after launch, all physicians who are expected to use NEURACEQ have access to a training programme in order to ensure accurate and reliable interpretation of the PET images.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo po pogovoru in dogovoru s pristojnim nacionalnim organom v vsaki državi članici, kjer se trži zdravilo NEURACEQ, ob začetku dajanja zdravila v promet in po tem vsi zdravniki, za katere se predvideva, da bodo uporabljali zdravilo NEURACEQ, dostop do programa usposabljanja, da se zagotovi točna in zanesljiva interpretacija PET-slik.
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Po predhodnem pogovoru in privolitvi pristojnega nacionalnega organa v posamezni državi članici, kjer se zdravilo PROTELOS trži, bo imetnik dovoljenja za promet z zdravilom zagotovil, da bodo vsi zdravniki, za katere se predvideva, da bodo predpisovali zdravilo PROTELOS, dobili naslednji izobraževalni paket:
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Aripiprazole Mylan Pharma for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older is launched all healthcare professionals who are expected to prescribe Aripiprazole Mylan Pharma are provided with an information pack containing the following items:
Imetnik dovoljenja za promet mora zagotoviti, da bodo, po posvetu in v dogovoru z nacionalnim pristojnim organom, v vsaki državi članici, kjer se bo zdravilo Aripiprazol Mylan Pharma uporabljalo za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več v trajanju do 12 tednov, vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Aripiprazol Mylan Pharma za navedeno indikacijo, prejeli izobraževalno gradivo, ki bo vključevalo naslednje elemente:
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where EFFENTORA is marketed all healthcare professionals who are expected to prescribe EFFENTORA are provided with an information pack containing the following items:
Imetnik dovoljenja za promet z zdravilom bo po razgovoru in v soglasju s pristojnim nacionalnim organom v vseh državah članicah, kjer je zdravilo EFFENTORA v prometu, zagotovil, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo EFFENTORA predpisovali, prejeli izobraževalni paket z naslednjo vsebino:
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Eylea is marketed, at launch of the new indication myopic choroidal neovascularisation (myopic CNV) and periodically thereafter, all ophthalmological clinics where Eylea is expected to be used are provided with an updated physician information pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom zagotavlja, da bo po dogovoru z ustreznim nacionalnim organom v vsaki državi članici, kjer bo zdravilo Eylea na trgu, ob prihodu nove indikacije miopične horoidalne neovaskularizacije (miopične CNV) na trg in nato periodično, na vse očesne klinike, kjer se pričakuje, da bodo zdravilo Eylea uporabljali, predložil posodobljeno izobraževalno gradivo za zdravnike, ki vsebuje naslednje:
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where OZURDEX is marketed, at launch and after launch all ophthalmological clinics where OZURDEX is expected to be used are provided with an updated physician information pack containing the following elements:
Imetnik dovoljenja za promet zdravilom mora po dogovoru s pristojnimi nacionalnimi organi v državah članicah, v katerih se zdravilo OZURDEX prodaja, zagotoviti, da imajo vse okulistične ordinacije, za katere se pričakuje, da bodo uporabljale zdravilo OZURDEX, ob začetku prodaje in po njem na voljo posodobljen komplet informacij za zdravnika, ki vsebuje naslednje elemente:
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where VIZAMYL is marketed, at launch and after launch, all physicians who are expected to use VIZAMYL have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
MAH mora zagotoviti, da imajo po razpravi in dogovoru s pristojnim organom v državi, v kateri je zdravilo VIZAMYL na trgu, ob začetku trženja in po njem vsi zdravniki, ki bodo uporabljali zdravilo VIZAMYL dostop do usposabljanja, za zagotovitev točnosti in zanesljivosti interpretacij posnetkov PET.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to / are provided with the following items:
Imetnik dovoljenja za promet z zdravilom mora po razgovoru in dogovoru s pristojnimi državnimi organi v vsaki posamezni državi članici, kjer bo zdravilo Zalviso sproščeno, zagotoviti, da bodo vsi zdravstveni delavci, ki predpisujejo zdravilo Zalviso obveščeni z informacijskim pismom o dostopu do naslednjih dokumentov / ali jim bodo zagotovljeni naslednji dokumenti:
The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date physician information pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora po usklajevanju in pridobitvi soglasja pristojnih nacionalnih oblasti v vsaki državi članici, v kateri se zdravilo Lucentis trži, zagotoviti, da bo v času prihoda zdravila na trg in po njem vsem oftalmološkim klinikam, na katerih je mogoče pričakovati uporabo zdravila Lucentis, priskrbel najnovejše komplete navodil za zdravnika, ki morajo vsebovati sledeče:
The MAH shall ensure that, in accordance with the European Commission decision on the procedure EMEA/H/C/000898/A20/0018, all users of the spray application of this product are provided with
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo skladno z pridobljenim dovoljenjem za promet z zdravilom Evropske komisije za zdravilo EMEA/H/C/000898/A20/0018 vsi uporabniki tega zdravila v obliki pršilnika prejeli naslednje:
The MAH shall ensure that, within 2 years of the European Commission decision on this procedure (EMEA/H/C/000898/A20/0018), the product can only be used with a pressure regulator that caps the maximum pressure at 1.7 bars.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se bo v roku dveh let po pridobitvi dovoljenja za promet z zdravilom Evropske komisije za to zdravilo (EMEA/H/C/000898/A20/0018) izdelek uporabljal samo z regulatorjem tlaka z največjim tlakom 1,7 bara.
The MAH shall ensure the patient information leaflets include the following key messages:
MAH bo poskrbel, da bo navodilo za uporabo vsebovalo naslednja ključna sporočila:
The MAH shall implement a controlled distribution system for the Insuman Implantable 400 IU/ml strength solutions for infusion to ensure that the medicinal product is only available to centres with current certification by Medtronic as having the appropriate facilities and staff who have received adequate training in the use of the Medtronic MiniMed Implantable Pump and the Personal Pump Communicator (PPC).
Imetnik dovoljenja za promet z zdravilom (MAH) bo za zdravilo Insuman Implantable z jakostjo 400 i.e./ml raztopino za infundiranje izvajal sistem kontrolirane distribucije in bo poskrbel, da bo zdravilo na voljo le v centrih, ki imajo trenutno potrdilo družbe Medtronic, da ima center ustrezno infrastrukturo in osebje, ki je bilo deležno ustreznega usposabljanja za uporabo črpalke Medtronic MiniMed Implantable Pump in osebnega komunikatorja za črpalko (PPC – Personal Pump Communicator).
The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Imetnik dovoljenja za promet z zdravili mora izvajati program za preprečevanje nosečnosti (PPN) v vsaki državi članici.
The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Imetnik dovoljenja za promet z zdravilom dogovorjene ukrepe za spremljanje izpolni v časovnem okviru, določenem v dogovoru z nacionalnimi pristojnimi organi.
The MAH shall notify the EMA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State.
Imetnik dovoljenja za promet z zdravilom mora Evropsko agencijo za zdravila (EMA) ter ustrezne nacionalne predstavnike bolnikov in žrtev seznaniti s predlaganim datumom uvedbe na trg pred uvedbo v vsaki državi članici.
The MAH shall offer an educational program to all users of the spray application of this product.
Imetnik dovoljenja za promet z zdravilom mora ponuditi izobraževalni program vsem uporabnikom tega zdravila.
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and 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 Pharmacovigilance activities and intervetions 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 farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH shall perform the pharmacovigilance activities as agreed in the RMP presented in Module of the Marketing Authorisation and any subsequent updates.
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, sprejete v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah .
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP,predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed inthe RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Product for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH shall perform the required pharmacovigilance activities and intervention 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 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 Risk Management Plan (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 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 Risk Management Plan (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 Risk Management Plan 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 and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel 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 agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloţenem 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.
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 nadaljnih posodobitvah RMP.