natgillin/translations-raw huggingface dataset:
Timolol
TAFf
25 July 2014 EMEA/H/C/002418
25. julij 2014 EMEA/H/C/002418
The Committee considered that controls to ensure suitable and consistent quality of the medicine have not been shown to be adequate.
Odbor je menil, da nadzor za zagotovitev primerne in dosledne kakovosti zdravila ni bil zadosten.
More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Več informacij o dodelitvi statusa zdravila sirote je na voljo tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
This means that it was intended to be similar to a ‘reference medicine' containing the same active substance, but in a higher strength.
To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, saj naj bi vsebovalo enako zdravilno učinkovino, vendar v večji jakosti.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili, potem ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application since it would not be possible to provide the additional data regarding the quality of the medicine within the timetable required by the procedure.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da umika vlogo, ker ne bi bilo mogoče predložiti dodatnih podatkov v zvezi s kakovostjo zdravila v časovnih rokih, ki jih zahteva postopek.
Withdrawal of the marketing authorisation application for Neofordex (dexamethasone) EMA/443387/2014
Umik vloge za pridobitev dovoljenja za promet z zdravilom Neofordex (deksametazon) EMA/443387/2014
It was to be available as 40 mg tablets.
Na voljo naj bi bilo v obliki 40-miligramskih tablet.
Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl.
Ker je bilo zdravilo Neofordex ocenjeno kot hibridno zdravilo in ker so učinki visokoodmernega deksametazona pri multiplem mielomu dobro znani, je družba predložila rezultate študije, v kateri so raziskali, ali je zdravilo biološko enakovredno referenčnemu zdravilu Dectancyl.
Neofordex was developed as a ‘hybrid medicine'.
Zdravilo Neofordex je bilo razvito kot „hibridno zdravilo“.
The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Družba je predložila tudi študije iz literature o uporabi deksametazona za zdravljenje multiplega mieloma.
While the reference medicine Dectancyl is available as 0.5 mg tablets, Neofordex was to be available as 40 mg tablets.
Referenčno zdravilo Dectancyl je na voljo v obliki 0,5-miligramskih tablet, zdravilo Neofordex pa naj bi bilo na voljo v obliki 40-miligramskih tablet.
Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms.
Zdravilo Neofordex naj bi se uporabljalo v kombinaciji z drugimi zdravili za zdravljenje odraslih bolnikov z multiplim mielomom, pri katerih so se pojavili simptomi.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Neofordex.
Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Neofordex.
Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Neofordex did not outweigh its risks.
Zato je v času umika menil, da zaradi pomislekov glede kakovosti koristi zdravila Neofordex ne odtehtajo z njim povezanih tveganj.
On 17 July 2014, Laboratories CTRS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Neofordex, for the treatment of multiple myeloma.
Družba Laboratories CTRS je dne 17. julija 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Neofordex, namenjenim zdravljenju multiplega mieloma.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Neofordex could not have been approved for the treatment of multiple myeloma.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Neofordex ni mogoče odobriti za zdravljenje multiplega mieloma.
The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells.
Zdravilna učinkovina v zdravilih Neofordex in Dectancyl, deksametazon, spada v skupino zdravil, imenovanih kortikosteroidi, ki se vežejo na receptorje v različnih vrstah imunskih celic in tako zmanjšajo aktivnost imunskega sistema (naravnega obrambnega mehanizma telesa).
In addition, by providing a high dose in a single tablet Neofordex was expected to simplify dosing.
Poleg tega naj bi velik odmerek v eni sami tableti zdravila Neofordex poenostavil odmerjanje.
What is Neofordex?
Kaj je zdravilo Neofordex?
Withdrawal of the marketing authorisation application for Neofordex (dexamethasone)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Neofordex (deksametazon)
Neofordex was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.
Zdravilo Neofordex je bilo dne 6. junija 2010 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za zdravljenje multiplega mieloma.
Neofordex is a corticosteroid medicine that contains the active substance dexamethasone.
Zdravilo Neofordex je kortikosteroid, ki vsebuje zdravilno učinkovino deksametazon.
What was Neofordex expected to be used for?
Za kaj naj bi se zdravilo Neofordex uporabljalo?
How is Neofordex expected to work?
Kako naj bi zdravilo Neofordex delovalo?
dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom deksametazon se pri multiplem mielomu uporablja skupaj s kemoterapijo, da izboljša njeno učinkovitost in zmanjša določene neželene učinke zdravljenja raka, kot sta navzea (slabost) in bruhanje.
For the suspension to be lifted, National competent authorities of Member States or reference Member States, if applicable, shall ensure that the following condition is fulfilled by the MAHs:
Za preklic začasnega umika morajo pristojni nacionalni organi držav članic ali referenčnih držav članic zagotoviti, kadar je to primerno, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednji pogoj:
The MAHs should appropriately reformulate the product taking into account its misuse potential.
Imetniki dovoljenja za promet morajo ustrezno reformulirati zdravilo ob upoštevanju možnosti za napačno uporabo.
Conditions for lifting the suspension of the marketing authorisations for methadone oral solutions containing povidone
Pogoji za preklic začasnega umika dovoljenj za promet s peroralnimi raztopinami, ki vsebujejo metadon in povidon
Annex IV Condition for lifting the suspension of the marketing authorisations
Pogoj za preklic začasnega umika dovoljenj za promet z zdravili
The Agency will facilitate these efforts.
Agencija bo spodbujala ta prizadevanja.
Draft agenda and list of speakers
Osnutek dnevnega reda in seznam govornikov
The Agency aims to allocate 10 minutes per person.
Cilj agencije je dodeliti deset minut na osebo.
• Name of the individual.
• ime posameznika;
In such case no prior registration is required.
V tem primeru ni potrebna predhodna prijava.
The Agency processes personal data in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Agencija obdeluje osebne podatke v skladu z Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov.
Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
Poslovnik o organizaciji in izvedbi javne obravnave v okviru Odbora za ocenjevanje tveganja na področju farmakovigilance (PRAC)
The PRAC Chair gives the floor to the speakers.
Predsednik odbora PRAC prepusti besedo govornikom.
Key principles
Ključna načela
The Agency cannot be held liable for any expenses occurred in case of cancellation.
Agencija ne prevzema odgovornosti za nobene stroške, ki lahko nastanejo v primeru odpovedi.
• Level of public interest.
• raven javnega interesa.
Speakers will be alerted when their allocated time has nearly expired.
Govorniki bodo opozorjeni, ko se jim bo dodeljeni čas skoraj iztekel.
All public hearings will be conducted in English.
Vse javne obravnave bodo potekale v angleškem jeziku.
Arrangements to be put in place for such non-public hearings fall outside the scope of these rules of procedure.
Ureditev, ki jo je treba vzpostaviti za take nejavne obravnave, ne spada na področje uporabe tega poslovnika.
He or she shall also receive the reasons why the request has not been accepted.
Predloži se jim tudi utemeljitev, zakaj njihov zahtevek ni bil sprejet.
• Potential impact of possible regulatory actions on therapeutic practice and availability of treatments.
• morebitni vpliv možnih regulativnih ukrepov o terapevtski praksi in razpoložljivost oblik zdravljenja;
The time the Agency allocates to each speaker is dependent upon the number of requests received.
Čas, ki ga agencija dodeli posameznemu govorniku, je odvisen od števila prejetih zahtevkov.
• Contact information (postal address, e-mail address, telephone number).
• kontaktne podatke (poštni naslov, e-naslov, telefonsko številko);
The legal basis for holding public hearings in the defined procedures is Article 107j of Directive 2001/83/EC:
Pravna podlaga za izvajanje javnih obravnav v okviru določenih postopkov je člen 107j Direktive 2001/83/ES:
Members of the public can participate actively, as speakers, or they can opt to participate as observers.
Predstavniki javnosti lahko sodelujejo dejavno kot govorniki ali pa se odločijo, da bodo sodelovali kot opazovalci.
Early consideration is necessary to allow sufficient time to organise the meeting.
To mora storiti zgodaj, da je na voljo dovolj časa za organizacijo srečanja.
• Therapeutic effect of the medicine/class of medicines and availability of therapeutic alternatives.
• terapevtski učinek zdravila/razreda zdravil in razpoložljivost terapevtskih alternativ;
Public hearings are open to all members of the public.
Javne obravnave so odprte za vse predstavnike javnosti.
However, the PRAC continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine(s) concerned.
Vendar ostaja odbor PRAC izključno odgovoren za izdajo znanstvenih priporočil o varnosti zadevnih zdravil.
The announcement is published on the Agency's website1, together with:
Objavi se na spletišču agencije1 skupaj s:
Specific arrangements will be put in place to allow wide media coverage of the public hearing.
Vzpostavljena bo posebna ureditev, da se omogoči široka medijska pokritost javne obravnave.
Speakers should be aware that they have a fixed maximum time to make their intervention.
Govorniki se morajo zavedati, da imajo fiksno določen čas za govorno predstavitev.
• Nature and extent of the safety concern.
• naravo in obseg varnostnih zadržkov;
• Agency's contact email address and phone number.
• kontaktnim e-naslovom in telefonsko številko agencije;
Submitting a request to attend as observer
Predložitev zahtevka za udeležbo v vlogi opazovalca
The PRAC Chair concludes the public hearing and explains the next steps of the procedure.
Predsednik odbora PRAC zaključi javno obravnavo in pojasni naslednje korake postopka.
• Capacity (i.e. whether the person is speaking as a patient or carer, a healthcare professional, an academic or a representative of the pharmaceutical industry, irrespective of whether the person speaks as an individual or a representative of an organisation/pharmaceutical company).
• vlogo (tj. ali oseba govori kot bolnik ali negovalec, zdravstveni delavec, akademik ali predstavnik farmacevtske industrije, ne glede na to, ali ima oseba govorno predstavitev kot posameznik ali predstavnik neke organizacije/farmacevtske družbe);
• Affiliation (i.e. name of the organisation/pharmaceutical company the individual represents), if applicable.
• povezavo (tj. ime organizacije/farmacevtske družbe, ki jo posameznik predstavlja), če je ustrezno;
• Feasibility to hold a public hearing in light of the urgency of the matter.
• izvedljivost izvedbe javne obravnave glede na nujnost zadeve;
These requests will only be accommodated if space permits.
Ti zahtevki se bodo upoštevali le, če je na voljo dovolj prostora.
The assessment report will be made public once the decision-making process has been finalised.
Poročilo o oceni bo objavljeno po koncu postopka odločanja.
The order and time available for each intervention is determined in the agenda.
Vrstni red in razpoložljiv čas za vsako govorno predstavitev sta opredeljena v dnevnem redu.
If they are unable to present in English, the European Medicines Agency (hereafter referred to as “Agency”) will provide translation from the official EU languages into English.
Če svojih mnenj ne morejo predstaviti v angleškem jeziku, bo Evropska agencija za zdravila (v nadaljnjem besedilu: agencija) zagotovila prevod iz drugih uradnih jezikov v angleškega.
At the start of each referral the PRAC will consider the need to hold a public hearing as described in section 2.2.
Odbor PRAC bo vsakič, ko prejme napotitev, preučil potrebo, ali je treba opraviti javno obravnavo, kot je opisano v razdelku 2.2.
Further information is provided on the Agency's website under “Privacy statement”.
Več informacij je na voljo na spletišču agencije v razdelku „Privacy statement“ (Izjava o varstvu osebnih podatkov).
The requester should also clearly indicate whether he or she intends to participate in person or whether the intervention will be made via teleconference.
Vlagatelj zahtevka mora poleg tega jasno navesti, ali se namerava javne obravnave udeležiti osebno ali bo imel govorno predstavitev prek telekonference.
In case of cancellation, the Agency will publically announce as early as possible, and will provide a justification for such cancellation.
V primeru odpovedi bo o tem čim prej obvestila javnost in predložila ustrezno utemeljitev.
• A summary of the safety concern.
• povzetkom varnostnega zadržka;
If the speaker does not conclude his or her intervention after being asked to do so, the microphone may be turned off.
Če govornik ne zaključi govorne predstavitve po tem, ko je k temu pozvan, se mu lahko izključi mikrofon.
In situations where it is not feasible for the Agency to reschedule the public hearing, the Agency will announce on its website the modalities for receiving written contributions.
V primerih, ko agencija ne more preložiti javne obravnave, bo na svojem spletišču objavila načine za predložitev pisnih prispevkov.
The PRAC Chair can also stop a speaker if his or her intervention does not address the questions asked by the PRAC or if the speaker does not adhere to the general ground rules.
Predsednik odbora PRAC lahko poleg tega prekine govornika, če se v njegovi govorni predstavitvi ne obravnavajo vprašanja, ki jih je postavil odbor PRAC, ali če govornik ne upošteva splošnih osnovnih pravil.
Modalities of participation in a public hearing therefore include the following:
Načini sodelovanja na javni obravnavi lahko zato vključujejo naslednje:
• A brief outline of the planned intervention, specifically how it addresses the questions on which the PRAC is seeking public opinion and the estimated amount of time requested for the presentation.
• kratek opis načrtovane govorne predstavitve, natančneje, kako so v njej obravnavana vprašanja, v zvezi s katerimi želi odbor PRAC pridobiti javno mnenje, in predvideni čas, ki se zahteva za predstavitev.
If the number of requests still exceeds the allocated time, the Agency will review the requests and decide on the list of speakers, taking into account elements such as the most relevant speakers with regard to the questions to be addressed at the public hearing and/or the geographical spread of the speakers.
Če število zahtevkov še vedno presega dodeljeni čas, bo agencija preučila zahtevke in določila seznam govornikov, pri čemer bo upoštevala elemente, kot so najprimernejši govorniki glede na vprašanja, ki se bodo obravnavala na javni obravnavi, in/ali geografska porazdelitev govornikov.
The PRAC has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, Article 31 or Article 107i of Directive 2001/83/EC.
Odbor PRAC lahko opravi javno obravnavo v okviru postopka za napotitev iz varnostnih razlogov na podlagi člena 20 Uredbe (ES) št. 726/2004 oziroma člena 31 ali člena 107i Direktive 2001/83/ES.
The Agency reserves the right to cancel a public hearing in case circumstances emerge that impact on the feasibility of holding it.
Agencija si pridržuje pravico do odpovedi javne obravnave, če se pojavijo okoliščine, ki vplivajo na izvedljivost njene organizacije.
• Information about live-broadcast/web stream.
• informacijami o prenosu v živo/prenosu v živo prek spleta.
The Agency will endeavour to accommodate all speaking requests.
Agencija bo poskušala upoštevati vse zahtevke za govorno predstavitev.
If the PRAC cannot reach an agreement by consensus, the decision is taken by vote as provided for in the PRAC rules of procedure.
Če tega ne more storiti, se odločitev sprejme na podlagi glasovanja, kot je določeno v poslovniku odbora PRAC.
Media organisations who wish to cover the public hearing may attend as observers.
Medijske organizacije, ki želijo poročati o javni obravnavi, se je lahko udeležijo kot opazovalci.
The PRAC Chair, in collaboration with Agency staff, is responsible for the preparation of the public hearing and the conduct of the public hearing and shall take appropriate measures to ensure that the public hearing is run effectively and efficiently.
Predsednik odbora PRAC, ki je v sodelovanju z osebjem agencije odgovoren za pripravo javne obravnave in njenega vodenja, sprejme ustrezne ukrepe za zagotavljanje uspešnega in učinkovitega vodenja javne obravnave.
If the allocated time ends before a speaker has concluded his or her intervention, the PRAC Chair should remind him or her to do so.
Če se dodeljeni čas izteče, preden govornik zaključi svojo govorno predstavitev, ga mora predsednik odbora PRAC pozvati, naj to stori.
1 The Agency's website will serve as the European medicines webportal until further notice.
1 Spletišče agencije bo imelo do nadaljnjega funkcijo spletnega portala za evropska zdravila.
He or she states the purpose of the public hearing and presents the order of the day and operational aspects for the meeting.
Navede namen javne obravnave ter predstavi dnevni red in operativne vidike srečanja.
The primary purpose of a public hearing is to hear the public's view on the acceptability of the risks associated with the medicinal product/medicinal substance/class of medicinal products concerned, particularly in relation to its therapeutic effects and therapeutic alternatives available, as well as to seek suggestions and recommendations on the feasibility and acceptability of risk management and minimisation activities.
Glavni namen javne obravnave je prisluhniti mnenju javnosti o sprejemljivosti tveganj, povezanih z zdravilom/zdravilno učinkovino/skupino zadevnih zdravil, zlasti v zvezi s terapevtskimi učinki in razpoložljivimi terapevtskimi alternativami, ter pridobiti predloge in priporočila o izvedljivosti in sprejemljivosti dejavnosti obvladovanja in zmanjševanja tveganja.
The Agency shall, in consultation with the parties concerned, draw up rules of procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No
Agencija, po posvetovanju z zainteresiranimi stranmi, določi poslovnik, ki se uporablja za organizacijo in izvedbo javnih obravnav, v skladu s členom 78 Uredbe (ES) št. 726/2004.
Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.”
Kadar ima imetnik dovoljenja za promet ali druga oseba, ki namerava predložiti informacije, zaupne podatke, pomembne za vsebino postopka, lahko zahteva, da te podatke predstavi Odboru za ocenjevanje tveganja na področju farmakovigilance na obravnavi, ki ni javna.“
• Information on date and time of the public hearing.
• informacijami o datumu in uri javne obravnave;
• Where relevant, request for the provision of translation in case of attendance as a speaker, including information on which official EU language should be translated into English.
• kadar je ustrezno, zahtevo za zagotovitev prevoda v primeru udeležbe v vlogi govornika, vključno z informacijami o uradnem jeziku EU, iz katerega naj bi se prevajalo v angleški jezik.
Participants have to request this when they register to speak at the public hearing.
Udeleženci morajo to zahtevati, ko se prijavijo za govorno predstavitev na javni obravnavi.
The interests declared will be minuted in the meeting record.
Prijavljeni interesi se zapišejo v poročilu o srečanju.
Participation requests should be sent in writing to the Agency using a dedicated form and should include the following information:
Zahtevki za sodelovanje, ki jih je treba agenciji poslati pisno na posebnem obrazcu, morajo vključevati naslednje informacije:
The outcome of the discussion on the need to hold a public hearing, including a justification of the decision taken will be recorded in the minutes of the PRAC which are published on the Agency's website.
Izid razprave o potrebi po izvedbi javne obravnave, vključno z utemeljitvijo sprejete odločitve, bo evidentiran v zapisniku odbora PRAC, ki se objavi na spletišču agencije.
• A list of specific questions on which information from the public is sought during the public hearing.
• seznamom konkretnih vprašanj, glede katerih se med javno obravnavo poskušajo pridobiti informacije od javnosti;
• Information on how to ask for the provision of translation from an official EU language into English in case of attendance as a speaker.
• informacijami o tem, kako zaprositi za zagotovitev prevoda iz uradnega jezika EU v angleški jezik v primeru udeležbe v vlogi govornika;
• Registration information, including the deadline by which participants can register to attend the hearing as speakers or observers.
• informacijami v zvezi s prijavo, vključno z rokom, do katerega se lahko udeleženci prijavijo, da se obravnave udeležijo kot govorniki ali opazovalci;
The PRAC members may ask questions for clarification from the speaker once the speaker's intervention has finished.
Člani odbora lahko govorniku po tem, ko zaključi govorno predstavitev, postavijo vprašanja za pojasnitev.
Interventions given by participants at the public hearing should focus on providing responses to the questions asked by the PRAC.
Govorne predstavitve, ki jih imajo udeleženci javne obravnave, morajo biti osredotočene na predložitev odgovora na vprašanja, ki jih je zastavil odbor PRAC.