FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee on Herbal Medicinal Products (HMPC), with a view to promote an increasingly harmonised process for licensing and information on herbal substances across the EU, establishes Community herbal monographs for traditional and well-established herbal medicines as well as a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicines.
Slovenian: Odbor agencije za zdravila rastlinskega izvora (HMPC) za spodbujanje vse bolj usklajenega postopka za izdajo licenc in obveščanje o rastlinskih snoveh v vsej EU pripravlja rastlinske monografije Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora ter osnutek seznama o rastlinskih snoveh, pripravkih rastlinskega izvora in kombinacijah iz njih za uporabo v tradicionalnih zdravilih rastlinskega izvora.
English: The year also saw a number of high-profile opinions being established, such as the recommendation to suspend the marketing authorisation for Avandia and other medicines containing rosiglitazone, the suspension of the anti-obesity medicine sibutramine, and investigations into the childhood vaccines Rotarix and Rotateq, following the detection of unexpected viral material.
Slovenian: V letu 2010 je bilo izdanih tudi več pomembnih mnenj, na primer priporočilo za umik dovoljenja za promet za zdravilo Avandia in druga zdravila, ki vsebujejo rosiglitazon, ter umik dovoljenja za promet za zdravilo proti debelosti Sibutramine, opravljene so bile tudi preiskave otroških cepiv Rotarix in Rotateq po odkritju nepričakovanega virusnega materiala.
English: With increases in workload in almost all areas, this was another busy year for the Agency.
Slovenian: Zaradi povečanja delovne obremenitve na skoraj vseh področjih je bila agencija tudi v tem letu zelo zaposlena.
English: Herbal monographs List entries
Slovenian: Rastlinske monografije
English: Initial evaluation
Slovenian: Začetna ocena
English: Workload also increased on the veterinary side, with the number of applications for marketing authorisation and referrals exceeding expectations, and requests for scientific advice almost doubling in comparison with the previous year.
Slovenian: Delovna obremenitev se je povečala tudi na področju zdravil za uporabo v veterinarski medicini, kjer je število vlog za izdajo dovoljenja za promet z zdravili in napotitev preseglo pričakovanja, število zahtev za znanstveno svetovanje pa se je v primerjavi z letom prej skoraj podvojilo.
English: Referral procedures are used to resolve disagreements and address concerns among Member States.
Slovenian: Postopki napotitve se uporabljajo za reševanje sporov in obravnavo zaskrbljenosti med državami članicami.
English: • Two novel medicines for the treatment of ectoparasites, mainly fleas, in domestic pets.
Slovenian: • dve novi zdravili za zdravljenje ektoparazitov, predvsem bolh, pri hišnih živalih.
English: • A new H5N1 mock-up pandemic-influenza vaccine intended for the prevention of influenza during an officially declared pandemic situation (a mock-up pandemic vaccine is not intended for stockpiling, but can be used to speed up the availability of a final vaccine in the event of a pandemic, once the pandemic strain has been identified).
Slovenian: • novo modelno cepivo proti virusu pandemske gripe H5N1, namenjeno preprečevanju gripe v razmerah uradno razglašene pandemije (modelno pandemsko cepivo ni namenjeno ustvarjanju zalog, temveč ga je mogoče uporabljati za pospeševanje razpoložljivosti končnega cepiva v primeru pandemije po identifikaciji pandemskega seva);
English: An extensive outbreak of this bacterial disease, which is the causative agent of Q fever in man, occurred in the Netherlands in 2009.
Slovenian: Na Nizozemskem je bil leta 2009 obsežen izbruh te bakterijske bolezni, ki je povzročitelj mrzlice Q pri ljudeh.
English: Maximum Residue Limits
Slovenian: Mejne vrednosti ostankov
English: • EMA holds the first scientific workshop on nanomedicines.
Slovenian: • Agencija EMA organizira prvo znanstveno delavnico o nanozdravilih.
English: • EMA and Swissmedic agree sharing of information on H1N1 pandemic medicines.
Slovenian: • Agencija EMA in agencija Swissmedic se dogovorita o izmenjavi informacij o zdravilih proti virusu pandemske gripe H1N1.
English: Almost half (44) of all applications were for biosimilar or generic medicines and hybrid or informedconsent applications.
Slovenian: Skoraj polovica vlog (44) je bila za biološko podobna ali generična zdravila in hibridna zdravila, oziroma so to bile vloge s predhodnim soglasjem.
English: • EMA and EUnetHTA Joint Action start collaboration on improving European public assessment reports (EPARs) for better contribution to relative effectiveness assessments.
Slovenian: • Agencija EMA in mreža za skupno ukrepanje EUnetHTA (Evropska mreža za vrednotenje zdravstvenih tehnologij) začneta sodelovati na področju izboljšanja evropskih javnih poročil o oceni zdravila (EPAR) za boljši prispevek k analizi relativne učinkovitosti.
English: • EMA publishes policy on communicating safety issues relating to human medicines.
Slovenian: • Agencija EMA objavi politiko sporočanja varnostnih težav v zvezi z zdravili za uporabo v humani medicini.
English: There was a 5% decrease to 91 applications for initial evaluation of medicines.
Slovenian: Agencija je prejela 91 vlog za začetno oceno zdravil, kar ustreza 5-odstotnemu zmanjšanju.
English: • EMA publishes a new access-to-documents policy.
Slovenian: • Agencija EMA objavi novo politiko dostopa do dokumentov.
English: Referral procedures started and finalised
Slovenian: Začeti in dokončani postopki napotitve
English: The report praised the Agency for its efficiency and effectiveness in delivering high-quality scientific opinions on medicines for human and veterinary use, but also highlighted the need for the Agency, together with the European Commission and regulatory authorities in the Member States, to continue to adapt to future challenges and address new developments and responsibilities.
Slovenian: Na začetku leta je bilo objavljeno poročilo o oceni agencije, ki jo je opravila družba Ernst & Young, v katerem je bila pohvaljena za svojo uspešnost in učinkovitost pri zagotavljanju visokokakovostnih znanstvenih mnenj o zdravilih za uporabo v humani in veterinarski medicini, poudarjena pa je bila tudi potreba, da se agencija skupaj z Evropsko komisijo in regulativnimi organi v državah članicah še naprej prilagaja prihodnjim izzivom ter obravnava nov razvoj dogodkov in odgovornosti.
English: As was the case with human medicines, a redistribution of post-authorisation applications was observed, due to the new legislation on variations.
Slovenian: Kot pri zdravilih za uporabo v humani medicini je bila ugotovljena prerazporeditev vlog za dejavnosti po izdaji dovoljenja za promet z zdravilom zaradi nove zakonodaje o spremembah.
English: • EMA and European Centre for Disease Prevention and Control (ECDC) sign a cooperation agreement.
Slovenian: • Agencija EMA in Evropski center za preprečevanje in obvladovanje bolezni (ECDC) podpišeta sporazum o sodelovanju.
English: Inspections
Slovenian: Inšpekcijski pregledi
English: • EMA's Committee for Advanced Therapies issues public statement on concerns over unregulated medicinal products containing stem cells.
Slovenian: • Odbor agencije EMA za napredno zdravljenje (CAT) objavi javno izjavo o pomislekih glede nereguliranih zdravil, ki vsebujejo matične celice.
English: • EMA launches SME database to facilitate interaction between small and medium-sized enterprises.
Slovenian: • Agencija EMA vzpostavi podatkovno zbirko za mala in srednja podjetja (MSP) za spodbujanje vzajemnega delovanja malih in srednjih podjetij.
English: • A vaccine to reduce the shedding of Coxiella burnetii by infected cattle and goats.
Slovenian: • cepivo za omejitev širjenja bakterije Coxiella burnetii z okuženim govedom in kozami.
English: Highlights in 2010
Slovenian: Poudarki iz leta 2010
English: • EMA launches public consultation on ethical and good-clinical-practice (GCP) aspects of clinical trials conducted in third countries.
Slovenian: • Agencija EMA začne javno posvetovanje o etičnih vidikih in vidikih dobre klinične prakse glede kliničnih preskušanj, ki se izvajajo v tretjih državah.
English: CAP = centrally authorised product.
Slovenian: CAP = zdravilo, za katero je bilo izdano dovoljenje po centraliziranem postopku.
English: Scientific-advice and protocol-assistance requests received
Slovenian: Prejeti zahtevki za znanstveno svetovanje in pomoč pri pripravi protokola
English: • EMA adopts first opinion on compassionate use, for oseltamivir, to treat patients with a life threatening condition due to pandemic or seasonal flu.
Slovenian: • Agencija EMA sprejme prvo mnenje o sočutni uporabi za oseltamivir, ki se uporablja pri zdravljenju bolnikov v smrtni nevarnosti zaradi pandemske ali sezonske gripe.
English: Scientific advice is considered as a means to facilitate and improve earlier availability of medicinal products to patients and healthcare professionals, and as a means to promote innovation and research.
Slovenian: Znanstveno svetovanje se šteje za sredstvo poenostavitve in izboljšanja zgodnje razpoložljivosti zdravil za bolnike in zdravstvene delavce ter sredstvo za spodbujanje inovacij in raziskav.
English: • EMA and other stakeholders launch pilot for multi-stakeholder consultations in early-stage drug development.
Slovenian: • Agencija EMA in druge zainteresirane strani začnejo pilotna posvetovanja z več zainteresiranimi stranmi v zgodnji fazi razvoja zdravil.
English: Orphan medicines contribution
Slovenian: Prispevek za zdravila sirote
English: • EMA holds workshop with European and international experts to discuss the way forward in stem cell research and development.
Slovenian: • Agencija EMA organizira delavnico z evropskimi in mednarodnimi strokovnjaki za obravnavo prihodnjih ukrepov na področju raziskav in razvoja matičnih celic.
English: • EMA holds international workshop on clinical trials in the context of global medicines development.
Slovenian: • Agencija EMA organizira mednarodno delavnico o kliničnih preskušanjih v okviru svetovnega razvoja zdravil.
English: • EMA and US FDA agree to accept a single orphan-drug-designation annual report.
Slovenian: • Agencija EMA in ameriški Urad za prehrano in zdravila (Food and Drug Administration, FDA) se dogovorita o sprejetju enotnega letnega poročila o dodelitvah statusa zdravil sirot.
English: • Two H1N1 pandemic vaccines intended for the prophylaxis of influenza in an officially declared pandemic situation.
Slovenian: • dve pandemski cepivi proti virusu gripe H1N1, namenjeni profilaksi gripe v razmerah uradno razglašene pandemije;
English: • EMA Management Board launches new 'Road map to 2015'.
Slovenian: • Upravni odbor agencije EMA začne izvajati nov „časovni načrt do leta 2015“.
English: • EMA completes its safety review of Avastin, used in breast cancer.
Slovenian: • Agencija EMA dokonča varnostno presojo zdravila Avastin, ki se uporablja za zdravljenje raka dojk.
English: • EMA launches European paediatric research network (Enpr-EMA).
Slovenian: • Agencija EMA vzpostavi Evropsko mrežo za pediatrične raziskave (Enpr-EMA).
English: We implemented a series of measures to strengthen the Agency's procurement procedures in 2010, following some technical errors that had occurred over the previous few years.
Slovenian: Po nekaterih tehničnih napakah v zadnjih nekaj letih smo izvedli več ukrepov za izboljšanje postopkov javnega naročanja agencije v letu 2010.
English: • A designated orphan medicine produced using recombinant DNA technology, intended for the treatment of angioedema attacks.
Slovenian: • zdravilo s statusom zdravila sirote, izdelano na podlagi rekombinantne tehnologije DNK in namenjeno zdravljenju napadov angioedema.
English: • EMA starts review of Pandemrix over narcolepsy concerns.
Slovenian: • Agencija EMA začne presojo cepiva Pandemrix zaradi pomislekov glede narkolepsije.
English: Scientific advice is considered as a means to facilitate and improve earlier availability of veterinary medicines and as a means to promote innovation and research.
Slovenian: Znanstveno svetovanje se šteje za sredstvo poenostavitve in izboljšanja zgodnje razpoložljivosti zdravil za uporabo v veterinarski medicini ter sredstvo za spodbujanje inovacij in raziskav.
English: • EMA adopts new fees for marketing-authorisation applications.
Slovenian: • Agencija EMA sprejme nove pristojbine za vloge za izdajo dovoljenja za promet z zdravili.
English: This area covers the Agency's activities relating to the assessment and agreement of, and verification of compliance with, paediatric investigation plans (PIPs) and waivers by the Paediatric Committee (PDCO).
Slovenian: To področje zajema dejavnosti agencije v zvezi z oceno načrtov pediatričnih raziskav (paediatric investigation plan, PIP) in opustitev, sprejemanjem dogovora o njih in preverjanjem skladnosti z njimi, te dejavnosti pa izvaja Odbor za pediatrijo.
English: Introduction by the Acting Executive Director
Slovenian: Uvod vršilca dolžnosti izvršnega direktorja
English: First quarter: January-March 2010
Slovenian: Prvo četrtletje: januar-marec 2010
English: Scientific-advice requests received and finalised
Slovenian: Prejeti in dokončani zahtevki za znanstveno svetovanje
English: Initial applications (by medicinal product) Initial applications (by active substance)
Slovenian: Vloge za začetno oceno (po zdravilni učinkovini)
English: It aims at ensuring that post-authorisation monitoring and effective risk-management are continuously applied to veterinary medicines throughout the EU.
Slovenian: Cilj farmakovigilance je zagotavljati, da se za zdravila za uporabo v veterinarski medicini po vsej EU nenehno uporabljata spremljanje po izdaji dovoljenja za promet z zdravilom in učinkovito obvladovanje tveganja.
English: • A medicinal product intended for maintenance treatment of severe chronic obstructive pulmonary disease associated with chronic bronchitis in adult patients as add-on to bronchodilator treatment, presenting an oral treatment with a new mode of action.
Slovenian: • zdravilo, namenjeno vzdrževalnemu zdravljenju resne kronične obstruktivne pljučne bolezni, povezane s kroničnim bronhitisom pri odraslih bolnikih, kot dodatek zdravljenju z bronhodilatatorji, ki pomeni peroralno zdravljenje z novim načinom učinkovanja;
English: Medicines for children
Slovenian: Zdravila za otroke
English: Pharmacovigilance covers the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs) or any other drug-related problem.
Slovenian: Farmakovigilanca zajema znanost in dejavnosti, povezane z odkrivanjem, oceno, razumevanjem in preprečevanjem neželenih učinkov zdravil (adverse drug reaction, ADR) ali vseh drugih težav v zvezi z zdravili.
English: • EMA launches its new website.
Slovenian: • Agencija EMA uvede novo spletišče.
English: • Two designated orphan medicines intended for the treatment of pulmonary conditions; one for suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis, and another for idiopathic pulmonary fibrosis.
Slovenian: • dve zdravili s statusom zdravila sirote, namenjeni zdravljenju pljučnih bolezni, eno za supresivno terapijo kronične pljučne okužbe zaradi Pseudomonas aeruginosa pri cistični fibrozi, drugo pa za idiopatično pljučno fibrozo;
English: Third quarter: July-September 2010
Slovenian: Tretje četrtletje: julij-september 2010
English: • A medicinal product intended for the treatment of a musculoskeletal condition known as Dupuytren's contracture, presenting a non-surgical alternative.
Slovenian: • zdravilo, namenjeno zdravljenju kostno-mišičnega obolenja, imenovanega dupuytrenova kontraktura, ki je nekirurška alternativa.
English: • EMA and European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) sign cooperation agreement.
Slovenian: • Agencija EMA in Evropski center za spremljanje drog in zasvojenosti z drogami (EMCDDA) podpišeta sporazum o sodelovanju.
English: CAP EEA ADRs CAP non-EEA ADRs Non-CAP EEA ADRs non-CAP non-EEA ADRs EEA = European Economic Area.
Slovenian: ADR za CAP iz EGP ADR za CAP zunaj EGP ADR za neCAP iz EGP ADR za neCAP zunaj EGP
English: On top of the increasing volume of core business activities, the Agency reached a number of important milestones during the course of the year.
Slovenian: Agencija je lani poleg povečanega obsega glavnih dejavnosti poslovanja dosegla več pomembnih mejnikov.
English: Animal-health benefits of medicines for veterinary use recommended for approval in 2010
Slovenian: Koristi zdravil za uporabo v veterinarski medicini, priporočenih za odobritev v letu 2010, za zdravje živali
English: • EMA receives the 1,000th application for a paediatric investigation plan (PIP) or waiver.
Slovenian: • Agencija EMA prejme tisočo vlogo za načrt pediatričnih raziskav (paediatric investigation plan, PIP)
English: • Two medicinal products intended for the treatment of psychiatric conditions; one for moderate to severe manic episodes associated with bipolar I disorder, and another for the treatment of schizophrenia.
Slovenian: • dve zdravili, namenjeni zdravljenju psihičnih bolezni, eno za od zmerne do resne manične epizode, povezane z bipolarno motnjo tipa I, drugo pa za zdravljenje shizofrenije;
English: • A designated orphan medicine intended for the treatment of inborn errors in primary bile acid synthesis due to enzyme deficiencies.
Slovenian: • zdravilo s statusom zdravila sirote, namenjeno zdravljenju prirojenih napak pri sintezi primarne žolčne kisline zaradi pomanjkanja encimov;
English: Second quarter: April-June 2010
Slovenian: Drugo četrtletje: april-junij 2010
English: • EMA Management Board emphasises the importance of the European medicines network during the
Slovenian: • Upravni odbor agencije EMA poudari pomen Evropske mreže zdravil med pandemijo gripe H1N1.
English: On the human side, the number of post-authorisation activities, orphan-medicine designations, scientificadvice procedures and referrals continued to grow.
Slovenian: Na področju zdravil za uporabo v humani medicini se je še naprej povečevalo število dejavnosti po izdaji dovoljenja za promet z zdravilom, dodelitev statusa zdravil sirot, postopkov znanstvenega svetovanja in napotitev.
English: • A designated orphan medicine intended for the treatment of patients with chronic lymphocytic leukaemia.
Slovenian: • zdravilo s statusom zdravila sirote, namenjeno zdravljenju bolnikov s kronično limfocitno levkemijo;
English: The initial evaluation phase covers activities relating to the processing of marketing authorisation applications for veterinary medicines, ranging from pre-submission meetings with future applicants, through evaluation by the Committee for Medicinal Products for Veterinary Use (CVMP), to the granting by the European Commission of the marketing authorisation.
Slovenian: Začetna ocena zajema dejavnosti v zvezi z obdelavo vlog za pridobitev dovoljenja za promet za zdravila za uporabo v veterinarski medicini, od sestankov s prihodnjimi vlagatelji pred predložitvijo vloge, prek presoje, ki jo opravi Odbor za zdravila za uporabo v veterinarski medicini (CVMP), do tega, da Evropska komisija izda dovoljenje za promet z zdravilom.
English: The most notable new medicines for veterinary use recommended for marketing authorisation by the Agency's Committee for Medicinal Products for Veterinary Use (CVMP) in 2010 include the following:
Slovenian: Najpomembnejša nova zdravila za uporabo v veterinarski medicini, za katera je Odbor agencije za zdravila za uporabo v veterinarski medicini (CVMP) v letu 2010 priporočil, naj se zanje izda dovoljenje za promet, so:
English: Figure 8.
Slovenian: Graf 8.
English: CAP EEA reports CAP non-EEA reports Non-CAP EEA reports Non-CAP non-EEA reports EEA = European Economic Area.
Slovenian: Poročila za CAP iz EGP Poročila za CAP zunaj EGP Poročila za neCAP iz EGP Poročila za neCAP zunaj EGP
English: This includes the management of suspected ADRs in the pre- and post-authorisation phase, periodic safety-update reports (PSURs), risk-management plans (RMPs) and post-authorisation safety and efficacy/effectiveness studies.
Slovenian: To vključuje obvladovanje sumov neželenih učinkov zdravil pred izdajo dovoljenja za promet z zdravilom in po njej, redna poročila o varnosti zdravil, načrte obvladovanja tveganja ter študije o varnosti in učinkovitosti po izdaji dovoljenja za promet z zdravilom.
English: • A diagnostic agent intended as a pharmacological stress agent for radionuclide myocardial perfusion imaging.
Slovenian: • diagnostično sredstvo, namenjeno za uporabo kot farmakološko sredstvo obremenitve za radionuklidno perfuzijsko slikanje srčne mišice;
English: • Prepandemic-influenza vaccines intended for immunisation against the H5N1 subtype of the influenza-A virus.
Slovenian: • cepiva proti gripi v predpandemskem obdobju, namenjena cepljenju proti podtipu virusa H5N1 virusa gripe A;
English: The most notable new medicines for human use recommended for marketing authorisation by the Agency's Committee for Medicinal Products for Human Use (CHMP) in 2010 include the following:
Slovenian: Najpomembnejša nova zdravila za uporabo v humani medicini, za katera je Odbor za zdravila za uporabo v humani medicini (CHMP) v letu 2010 priporočil, naj se zanje izda dovoljenje za promet, so:
English: Significant recommendations for approval in 2010 Public-health benefits of medicines for human use recommended for approval in 2010
Slovenian: Koristi zdravil za uporabo v humani medicini, priporočenih za odobritev v letu 2010, za javno zdravje
English: Initial evaluation covers activities relating to the processing of marketing authorisation applications for medicines, from pre-submission discussion with future applicants, through evaluation by the CHMP, to the granting of a marketing authorisation by the European Commission.
Slovenian: Začetna ocena zajema dejavnosti v zvezi z obdelavo vlog za izdajo dovoljenja za promet za zdravila, od razprave s prihodnjimi vlagatelji pred predložitvijo vloge, prek presoje, ki jo opravi Odbor za zdravila za uporabo v humani medicini (CHMP), do tega, da Evropska komisija izda dovoljenje za promet z zdravilom .
English: • A designated orphan medicine intended for the treatment of Gaucher disease.
Slovenian: • zdravilo s statusom zdravila sirote, namenjeno zdravljenju gaucherjeve bolezni.
English: Figure 16.
Slovenian: Graf 16.
English: Applications for maximum residue limits (MRLs)
Slovenian: Vloge za mejne vrednosti ostankov
English: Paediatric-investigation-plan (PIP) applications
Slovenian: Vloge za načrt pediatričnih raziskav
English: Figure 5.
Slovenian: Graf 5.
English: • A nasally administered influenza vaccine intended for the prophylaxis of influenza in children.
Slovenian: • cepivo proti gripi, ki se daje skozi nos in je namenjeno profilaksi gripe pri otrocih;
English: Referrals started Referrals finalised
Slovenian: Začete napotitve Dokončane napotitve
English: Figure 9.
Slovenian: Graf 9.
English: • EMA and Massachusetts Institute of Technology launch a joint project on regulatory science.
Slovenian: začneta izvajati skupni projekt o regulativni znanosti.
English: Requests received Requests finalised
Slovenian: Dokončani zahtevki
English: Figure 17.
Slovenian: Graf 17.
English: Figure 15.
Slovenian: Graf 15.
English: • Joint EMA and European Commission workshop starts reflection process on the way forward for the
Slovenian: • Na skupni delavnici agencije EMA in Evropske komisije se začne razmislek o prihodnji usmeritvi agencije in evropske regulativne mreže.
English: Veterinary medicines
Slovenian: Zdravila za uporabo v veterinarski medicini
English: Figure 12.
Slovenian: Graf 12.
English: Figure 14.
Slovenian: Graf 14.
English: Figure 10.
Slovenian: Graf 10.
English: Figure 7.
Slovenian: Graf 7.
English: Figure 11.
Slovenian: Graf 11.