natgillin/translations-raw huggingface dataset:
The marketing authorisation for Vibativ was suspended on 16 February 2012 due to GMP compliance issues of the finished product manufacturing site.
Dovoljenje za promet z zdravilomr Vibativ je bilo 16. februarja 2012 začasno umaknjeno zaradi težav s skladnostjo z GMP, ki so jih imeli na mestu izdelave končnega izdelka.
The marketing authorisation holder
Imetnik dovoljenja za promet
The marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom
The Marketing Authorisation Holder (MAH) conducted a review of all cases of respiratory arrest to determine if this adverse reaction occurred independently of hypersensitivity reaction or cardiac arrest (known risks of regadenoson).
Imetnik dovoljenja za promet z zdravilom je pregledal vse primere zastoja dihanja za ugotovitev, ali se je ta neželeni učinek pojavil neodvisno od preobčutljivostne reakcije ali srčnega zastoja (ki sta znani tveganji pri uporabi regadenozona).
The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet z zdravili se mora s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnih gradiv za uporabo zdravila VPRIV pri infundiranju na domu, vključno s sredstvi obveščanja, načini distribucije in vsemi drugimi vidiki programa.
The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Imetnik dovoljenja za promet z zdravilom bo podrobnosti sistema nadzorovane distribucije za 20 ml vialo zdravila Revatio 0,8 mg/ml raztopina za injiciranje uskladil s pristojnimi nacionalnimi organi in tak program izvajal na nacionalni ravni tako, da bo pred predpisovanjem zdravila vsem zdravstvenim delavcem, ki nameravajo predpisovati in/ali izdajati zdravilo Revatio 0,8 mg/ml raztopina za injiciranje, zagotovil:
The Marketing Authorisation Holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally.
Imetnik dovoljenja za promet z zdravilom se bo z nacionalnimi pristojnimi organi dogovoril o podrobnem izobraževalnem programu o infundiranju zdravila Fabrazyme doma pred nacionalno uvedbo programa.
The Marketing Authorisation Holder (MAH) shall conduct an educational programme to ensure that all physicians who are expected to prescribe/use Inflectra are aware of:
Imetnik dovoljenja za promet z zdravilom mora izvesti izobraževalni program, da zagotovi seznanitev vseh zdravnikov, ki bodo predpisovali/uporabljali zdravilo Inflectra, z naslednjim:
The Marketing Authorisation Holder (MAH) shall conduct an educational programme to ensure that all physicians who are expected to prescribe/use Remicade are aware of:
Imetnik dovoljenja za promet z zdravilom mora izvesti izobraževalni program, da zagotovi seznanitev vseh zdravnikov, ki bodo predpisovali/uporabljali zdravilo Remicade, z naslednjim:
The Marketing Authorisation Holder (MAH) shall conduct an educational programme to ensure that all physicians who are expected to prescribe/use Remsima are aware of:
Imetnik dovoljenja za promet z zdravilom mora izvesti izobraževalni program, da zagotovi seznanitev vseh zdravnikov, ki bodo predpisovali/uporabljali zdravilo Remsima, z naslednjim:
The Marketing Authorisation Holder (MAH) shall develop an educational programme for Xyrem to ensure that physicians who intend to prescribe Xyrem are aware about the posology of Xyrem and about the important risks.
Imetnik dovoljenja za promet bo razvil izobraževalni program za zdravilo Xyrem in s tem zagotovil, da bodo zdravniki, ki nameravajo predpisovati zdravilo Xyrem, poznali odmerjanje zdravila Xyrem in pomembna tveganja.
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Atripla are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, pri katerih se pričakuje, da bodo predpisovali/uporabljali zdravilo Atripla, dobili izobraževalni komplet za zdravnike, ki vsebuje naslednje:
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide Teva are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Leflunomide Teva dobili izobraževalno gradivo, ki vsebuje:
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Repso are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Repso dobili izobraževalno gradivo, ki vsebuje:
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Stribild are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Stribild, prejeli izobraževalni paket za zdravnika, ki bo vseboval:
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Truvada in adult patients are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Imetnik dovoljenja za promet z zdravilom zagotovi, da vsi zdravniki, ki naj bi predpisovali/uporabljali zdravilo Truvada pri odraslih bolnikih, prejmejo izobraževalni paket za zdravnike, ki vsebuje Povzetek glavnih značilnosti zdravila in ustrezno izobraževalno gradivo, kot je navedeno v nadaljevanju:
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Viread in adults and/or paediatric patients are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdraviloViread pri odraslih in/ali pediatričnih bolnikih, prejeli izobraževalni paket za zdravnika, ki bo vseboval Povzetek glavnih značilnosti zdravila in primerne izobraževalne brošure, kot je navedeno v nadaljevanju:
The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide Teva.
Imetnik dovoljenja za promet z zdravilom zagotavlja, da bodo kakršnekoli spremembe v varnostnem profilu referenčnega zdravila, ki bi zahtevale spremembe Načrta za obvladovanje tveganja ali Informacij o zdravilu, nemudoma implementirane v zadevne dokumente za zdravilo Leflunomid Teva.
The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide Winthrop.
Imetnik dovoljenja za promet mora zagotoviti, da so vse spremembe ki se nanašajo na varnostni profil referenčnega zdravila in zadevajo spremembe Načrta za obvladovanje tveganja (RMP) ali informacije o zdravilu takoj usklajene z zdravilom Leflunomid Winthrop.
The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo izobraževalni program, ki ga je izvajal za odobrene indikacije zdravljenja osteoporoze pri postmenopavzalnih ženskah in pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi, in.zdravljenja osteoporoze zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi pri postmenopavzalnih ženskah in pri moških, pri katerih obstaja povečano tveganje za zlom, posodobljen.
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following:
Imetnik dovoljenja za promet bo zagotovil, da bo ob prihodu zdravila na trg vsem zdravnikom, ki predpisujejo zdravilo NovoThirteen in za katere se pričakuje, da ga bodo predpisovali, poslano pismo z izobraževalnim kompletom.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet mora pred lansiranjem zdravila zagotoviti, da prejmejo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Cimzia, paket z informacijami za zdravnike, ki vsebuje:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Entyvio are provided with a physician pack containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred začetkom trženja zdravila vsi zdravniki, ki bodo predpisovali/uporabljali zdravilo Entyvio, imeli na voljo naslednje:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Leflunomide Winthrop are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Leflunomid Winthrop dobili izobraževalno gradivo, ki vsebuje:
The Marketing Authorisation Holder (MAH) shall ensure, at launch, that physicians who are expected to prescribe/use Hirobriz Breezhaler and pharmacists are provided with an information card containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Hirobriz Breezhaler, in farmacevti prejeli informativni letak, ki bo vseboval naslednje informacije:
The Marketing Authorisation Holder (MAH) shall ensure, at launch, that physicians who are expected to prescribe/use Onbrez Breezhaler and pharmacists are provided with an information card containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Onbrez Breezhaler, in farmacevti prejeli informativni letak, ki bo vseboval naslednje informacije:
The Marketing Authorisation Holder (MAH) shall ensure, at launch, that physicians who are expected to prescribe/use Oslif Breezhaler and pharmacists are provided with an information card containing the following elements:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Oslif Breezhaler, in farmacevti prejeli informativni letak, ki bo vseboval naslednje informacije:
The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular healthcare establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow- up of patients treated with ChondroCelect in the healthcare establishment, receive training as per the educational programme described in the risk management plan.
Imetnik dovoljenja za promet z zdravilom (MAH) mora določeni zdravstveni ustanovi pred dobavo zdravila v skladu z izobraževalnim programu, opisanem v načrtu za obvladovanje tveganj, zagotoviti usposabljanje vseh kirurgov in drugih zdravstvenih delavcev, ki uporabljajo in dajejo zdravilo ChondroCelect ali njegove sestavine, ter vseh, ki sodelujejo pri nadaljnjem spremljanju bolnikov, zdravljenih z zdravilom CondroCelect v zdravstveni ustanovi.
The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web- portal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
The Marketing Authorisation Holder (MAH) should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe Caprelsa are provided with an Educational pack.
Imetnik dovoljenja za promet mora zagotoviti, da bo po prihodu zdravila na tržišče zdravstvenemu osebju, za katere bo pričakovati, da bo uporabljalo in/ali predpisovalo zdravilo Caprelsa, priskrbel paket izobraževalnega gradiva.
The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da ob uvedbi nove indikacije vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali in/ali predpisovali zdravilo INOmax v okviru zdravljenja pred- ali pooperativne pljučne hipertenzije pri odraslih in otrocih, povezane s srčnim kirurškim posegom, dobijo izobraževalno gradivo.
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal dodatne študije in farmakovigilančne dejavnosti, ki so podrobno opisane v načrtu farmakovogilance, v skladu z verzijo 4 načrta obvladovanja tveganja (RMP –“Risk Management Plan”) predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta obvladovanja tveganja, ki jih odobri Odbor za zdravila za uporabo v humani medicini (CHMP).
The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
Imetnik dovoljenja za promet z zdravilom Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, Velika Britanija.
The marketing authorisation holder is Biogen Idec Limited.
Imetnik dovoljenja za promet je družba Biogen Idec Limited.
The marketing authorisation holder is Eisai Ltd.
Imetnik dovoljenja za promet z zdravilom je družba Eisai Ltd.
The marketing authorisation holder is Eli Lilly Netherlands B.V. The marketing authorisation is valid for an unlimited period.
Imetnik dovoljenja za promet je družba Eli Lilly Netherlands B.V. Dovoljenje za promet z zdravilom velja za nedoločen čas.
The marketing authorisation holder is N.V. Organon.
Imetnik dovoljenja za promet z zdravilom je družba N.V. Organon.
The marketing authorisation holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.
Imetnik dovoljenja za promet z zdravilom je Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, Velika Britanija.
The marketing authorisation holder is ViiV Healthcare UK Limited.
Imetnik dovoljenja za promet z zdravilom je družba ViiV Healthcare UK Limited.
The marketing authorisation holder is ViiV Healthcare UK Ltd.
Imetnik dovoljenja za promet z zdravilom je družba ViiV Healthcare UK Ltd.
The marketing authorisation holder is: Canyon Pharmaceuticals Limited
Imetnik dovoljenja za promet z zdravilom je: Canyon Pharmaceuticals Limited
The Marketing Authorisation Holder is: Teva B.V.
Imetnik dovoljenja za promet z zdravilom:
The Marketing Authorisation Holder is: Teva B.V.
Imetnik dovoljenja za promet z zdravilom: Teva B.V.
The Marketing Authorisation Holder is: Teva B.V.
Imetnik dovoljenja za promet z zdravilom: Teva Pharma B.V.,
The marketing authorisation holder must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo sistem farmakovigilance, predstavljen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in bo deloval, preden bo dal zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The marketing authorisation holder of VIAGRA is Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Imetnik dovoljenja za promet z zdravilom je Pfizer Limited, Sandwich, Kent, CT13 9NJ, Velika Britanija.
The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.
Pred začetkom trženja zdravila v državi članici, mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti obliko in vsebino zgoraj navedenega gradiva.
The Marketing Authorisation Holder shall agree the format and content of the above materials with the National Competent Authority of each Member State.
Imetnik dovoljenja za promet mora obliko in vsebino zgoraj opisanih materialov uskladiti z nacionalnimi pristojnimi organi vsake države članice.
The Marketing Authorisation Holder shall agree the format and content of the physician’s guide to prescribing with the National Competent Authority prior to launch in the Member State.
Imetnik dovoljenja za promet z zdravilom se bo z nacionalnim pristojnim organom, preden da zdravilo v promet v državi članici, dogovoril o obliki in vsebini priročnika o predpisovanju za zdravnike.
The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Pred uvedbo 20 ml viale zdravila Revatio 0,8 ml/mg raztopina za injiciranje na trg v določeni državi, bo imetnik dovoljenja za promet informacije za zdravstvene delavce in ciljne skupine uskladil s pristojnimi nacionalnimi organi v vsaki državi članici.
The Marketing Authorisation Holder shall agree to the format and content of the healthcare professional educational pack with the National Competent Authority prior to launch in the Member State.
Imetnik dovoljenja za promet z zdravilom se bo za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce pred dajanjem zdravila na trg dogovoril s pristojnim nacionalnim organom države članice.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati se uporabljajo kot osnova za vsakoletno ponovno oceno razmerja med koristmi in tveganji.
The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Cubicin susceptibility testing are provided with:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi laboratoriji, v katerih bodo predvidoma izvajali teste občutljivosti, prejeli:
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Eurartesim are provided with a healthcare profession educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Eurartesim, dobili izobraževalno gradivo za zdravstvene delavce, ki vsebuje:
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Valdoxan, are provided with patient booklets to be distributed to their patients being prescribed this medicine.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, ki bodo predvidoma predpisovali ali uporabljali zdravilo Thymanax, prejeli brošure za bolnike, da jih bodo razdelili svojim bolnikom, katerim bodo predpisali to zdravilo.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Vibativ are provided with a healthcare professional educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom vsem zdravnikom, za katere pričakuje, da bodo predpisovali ali uporabljali zdravilo Vibativ, zagotovi izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje:
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Victrelis are provided with a healthcare professional educational pack containing the following at launch:
Imetnik dovoljenja za promet z zdravilom mora vsem zdravnikom, za katere pričakuje, da bodo predpisovali ali uporabljali zdravilo Victrelis, ob prihodu zdravila na trg priskrbeti komplet izobraževalnega gradiva, namenjenega zdravnikom, ki vsebuje:
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe Vectibix are provided with educational materials informing them of the importance of RAS (KRAS and NRAS) ascertainment before treatment with panitumumab.
Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, od katerih se pričakuje predpisovanje zdravila Vectibix, prejeli izobraževalna gradiva, ki jih bodo informirala o pomembnosti določitve RAS (KRAS in NRAS) pred zdravljenjem s panitumumabom.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo YERVOY, prejeli:
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Cubicin are provided with:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, ki bodo predvidoma predpisovali/uporabljali zdravilo Cubicin, prejeli:
The Marketing Authorisation Holder shall ensure that Health care professionals who intend to prescribe or dispense MULTAQ are provided with a SmPC, a Prescriber check list and the MULTAQ Information Card.
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravstveni delavci, ki nameravajo predpisovati ali izdajati zdravilo MULTAQ dobili povzetek glavnih značilnosti zdravila (SmPC), kontrolni seznam za predpisovalca in informativno kartico o zdravilu MULTAQ.