natgillin/translations-raw huggingface dataset:
Why is Alprolix approved?
Zakaj je bilo zdravilo Alprolix odobreno?
What benefits of Alprolix have been shown in studies?
Kakšne koristi je zdravilo Alprolix izkazalo v študijah?
Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Izdaja zdravila Alprolix je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Alprolix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2007.
Ker je bolnikov s hemofilijo B malo, velja ta bolezen za redko, zato je bilo zdravilo Alprolix 8. junija 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What are the risks associated with Alprolix?
Kakšna tveganja so povezana z zdravilom Alprolix?
Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.
Zdravilo Alprolix se je izkazalo za učinkovito tako pri preprečevanju kot pri zdravljenju krvavitev v dveh glavnih študijah pri bolnikih s hemofilijo B.
Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Zdravilo Alprolix je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
For more information about treatment with Alprolix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Alprolix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Alprolix, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Alprolix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Alprolix contains the active substance eftrenonacog alfa.
Zdravilo Alprolix vsebuje zdravilno učinkovino eftrenonakog alfa.
Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Študije kažejo, da je zdravilo Alprolix učinkovito pri preprečevanju in zdravljenju krvavitev pri bolnikih s hemofilijo B, varnost zdravila pa je primerljiva z drugimi zdravili, ki vsebujejo faktor IX.
Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Zdravila, ki vsebujejo faktor IX, lahko povzročijo težave zaradi tvorjenja krvnih strdkov v krvnih žilah.
Alprolix is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Zdravilo Alprolix se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor IX.
Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Pri nekaterih bolnikih, ki jemljejo zdravila s faktorjem IX, obstaja tudi tveganje, da se bodo pri njih pojavili zaviralci (protitelesa) faktorja IX, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
How is Alprolix used?
Kako se zdravilo Alprolix uporablja?
How does Alprolix work?
Kako zdravilo Alprolix deluje?
Asparaginase has been used to treat cancer for many years and is authorised in EU countries under several trade names.
Asparaginaza se že vrsto let uporablja za zdravljenje raka in je v EU odobrena pod različnimi trgovskimi imeni.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Vlogo so umaknili po tem, ko je odbor CHMP že ocenil začetno dokumentacijo, ki jo je predložilo podjetje, in oblikoval seznam vprašanj.
Withdrawal of the marketing authorisation application for Graspa (L-asparaginase) EMA/431413/2018
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (L-asparaginaza) EMA/431413/2018
The company had not yet responded to the questions at the time of the withdrawal.
Podjetje ob umiku vloge še ni odgovorilo na zastavljena vprašanja.
On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL).
Podjetje Erytech Pharma S.A. je 22. junija 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Graspa, namenjenim zdravljenju akutne limfoblastne levkemije (ALL).
Asparagine is an amino acid produced by healthy cells in the body.
Asparagin je aminokislina, ki jo proizvajajo zdrave celice v telesu.
Withdrawal of the marketing authorisation application for Graspa (L-asparaginase)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (L-asparaginaza)
The company provided data from a main study which compared Graspa with asparaginase (not enclosed in blood cells) in 80 patients aged 1 to 55 years with Philadelphia chromosome negative ALL whose disease had not improved with other treatment or had come back.
Podjetje je predložilo podatke iz glavne študije, v kateri so zdravilo Graspa primerjali z asparaginazo (ki ni bila vključena v krvne celice) pri 80 bolnikih, starih od enega leta do 55 let, z akutno limfoblastno levkemijo, negativno za kromosom Philadelphia, pri katerih se bolezen z drugim zdravljenjem ni izboljšala ali se je ponovila.
Graspa was expected to be used in combination with other cancer medicines to treat adults and children with ALL that was not related to a particular genetic change (known as ‘Philadelphia chromosome negative').
Zdravilo Graspa naj bi se uporabljalo v kombinaciji z drugimi zdravili proti raku za zdravljenje odraslih in otrok z akutno limfoblastno levkemijo, ki ni povezana z določeno genetsko spremembo (znano kot „negativna za kromosom Philadelphia“).
However, lymphoblastic leukaemia cells cannot produce the amino acid and therefore they take it from the blood since they need it for their rapid growth.
Limfoblastne levkemične celice pa te aminokisline ne morejo proizvajati in jo zato jemljejo iz krvnega obtoka, saj jo potrebujejo za hitro rast.
Also, data were too limited to show how much Graspa's effectiveness was reduced by antibodies or how safe it was in children or after repeated treatments.
Podatki so bili tudi preveč omejeni, da bi z njimi lahko ugotovili, v kolikšnem obsegu protitelesa zmanjšajo učinkovitost zdravila Graspa in kako varno je zdravilo za otroke ali pri večkratnem zdravljenju.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa.
Podjetje je odbor CHMP obvestilo, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Graspa.
It was to be used if the ALL did not improve with standard treatment or if it had come back after such treatment.
Uporabljalo naj bi se, kadar se akutna limfoblastna levkemija ne izboljša s standardnim zdravljenjem ali se po tovrstnem zdravljenju ponovi.
Graspa is a cancer medicine that contains the active substance L-asparaginase that has been enclosed in red blood cells.
Graspa je zdravilo za zdravljenje raka, ki vsebuje učinkovino L-asparaginazo, vključeno v rdeče krvne celice.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the data provided were not sufficient to conclude on Graspa's benefit and risk.
Podjetje je v dopisu, s katerim je agencijo obvestilo o umiku vloge, navedlo, da predloženi podatki ne zadoščajo za sklepanje o koristih in tveganjih zdravila Graspa.
What was Graspa expected to be used for?
Za kaj naj bi se zdravilo Graspa uporabljalo?
The CHMP was concerned that the medicine contains a different type of asparaginase to that used in clinical studies and that the data provided were not sufficient to show how the medicine behaved in the body or how well it worked compared with other asparaginase medicines.
Izrazil je zadržek, ker zdravilo vsebuje drugačno vrsto asparaginaze, kot so jo uporabljali v kliničnih študijah, in ker predloženi podatki niso zadoščali za prikaz obnašanja zdravila v telesu ali njegove učinkovitosti v primerjavi z drugimi zdravili z asparaginazo.
In Graspa, L-asparaginase is enclosed in red blood cells because it was expected that this would allow the enzyme to work while protecting it from being broken down in blood and from antibodies that may attach to it and stop it from working.
L-asparaginaza v zdravilu Graspa je vključena v rdeče krvne celice, ker je bilo pričakovano, da bo encim tako lahko učinkoval, hkrati pa bo zaščiten pred razgradnjo v krvi in pred protitelesi, ki bi se lahko pritrdila nanj in tako preprečila njegovo delovanje.
What is Graspa?
Kaj je zdravilo Graspa?
How does Graspa work?
Kako zdravilo Graspa deluje?
Giving the enzyme L-asparaginase destroys asparagine in the blood and deprives the leukaemia cells of this amino acid, causing them to die.
Dajanje encima L-asparaginaze uniči asparagin v krvi in levkemične celice prikrajša za to aminokislino ter jih tako uniči.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Graspa did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Graspa zaradi pomanjkanja dokazov o učinkovitosti ne odtehtajo z njim povezanih tveganj.
Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 October 2006 for ALL.
Zdravilo Graspa je bilo 27. oktobra 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za akutno limfoblastno levkemijo.
Graspa was intended to be given by infusion (drip) into a vein.
Zdravilo Graspa naj bi se dajalo z infundiranjem (kapalno infuzijo) v veno.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Graspa ni mogoče odobriti za zdravljenje akutne limfoblastne levkemije.
This summary was last updated in October 2014.
Povzetek je bil nazadnje posodobljen oktobra 2014.
Mucosal disease is usually fatal.
Mukozna bolezen je običajno smrtna.
The effectiveness of the vaccine was first studied in a number of laboratory studies in cattle.
Učinkovitost cepiva so najprej preučevali v več laboratorijskih študijah na govedu.
Protection starts three weeks after vaccination and lasts for one year.
Zaščita začne učinkovati po treh tednih od cepljenja in traja eno leto.
The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014.
Evropska komisija je dovoljenje za promet z zdravilom Bovela, veljavno po vsej Evropski uniji, odobrila dne 22/12/2014.
Other information about Bovela:
Druge informacije o zdravilu Bovela:
What benefit has Bovela shown during the studies?
Kakšne koristi je zdravilo Bovela izkazalo med študijami?
The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.
Najpogostejši neželen učinek (opažen pri več kot 1 od 100 živali) je bilo povišanje telesne temperature (v normalnem razponu) v štirih urah po cepljenju, ki pa je spontano izzvenelo v 24 urah.
However, for the vaccinated group the period of infection was either before vaccination or before the start of protection.
Vendar pa je v cepljeni skupini do okužbe prišlo bodisi pred cepljenjem bodisi pred začetkom učinkovanja zaščite.
What is the risk associated with Bovela?
Kakšna tveganja so povezana z zdravilom Bovela?
In the field study 98.5% of vaccinated cattle sampled (range 269-274 animals) developed antibodies to both BVD virus types.
V terenski študiji je 98,5 % cepljenega goveda, zajetega v vzorec (razpon 269- 274 živali), razvilo protitelesa proti obema tipoma virusa goveje virusne diareje.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Bovela večje od z njim povezanih tveganj za odobreno indikacijo, in priporočil odobritev dovoljenja za promet z zdravilom Bovela.
The purpose of the studies was to establish how long it took for cattle to be fully protected, the length of time protection against BVD lasts, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine in calves.
Namen teh študij je bil ugotoviti, po kolikšnem času je govedo popolnoma zaščiteno, koliko časa traja zaščita pred govejo virusno diarejo in kako maternalna protitelesa (ki se prenašajo z matere na mladiča) vplivajo na učinkovitost cepiva pri teletih.
Bovine viral diarrhoea vaccine (modified live)
Cepivo proti bovini virusni driski (modificirano živo)
Why has Bovela been approved?
Zakaj je bilo zdravilo Bovela odobreno?
In the future, if the animals are exposed to the virus the immune system will be able to respond more quickly.
Ob morebitni ponovni izpostavitvi virusu se bo imunski sistem lahko odzval hitreje.
Bovela is a vaccine.
Zdravilo Bovela je cepivo.
Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus (BVDV-1 and BVDV-2).
Zdravilo Bovela je veterinarsko cepivo, ki vsebuje dva tipa modificiranega živega virusa goveje virusne diareje (BVDV-1 in BVDV-2).
The vaccine is given to cattle as a single injection into the muscle.
Cepivo se govedu daje z enkratno injekcijo v mišico.
The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.
Glavno merilo učinkovitosti je bilo zmanjšanje števila trajno okuženih novorojenih telet, kar so merili s testi za ugotavljanje prisotnosti posameznega virusa.
In the group vaccinated with Bovela five out of 1,216 (0.4%) newborn calves were persistently infected with the virus, whereas in the group given the dummy injection there were ten persistently infected newborn calves out of 1,183 born (0.8%).
V skupini, ki je prejela zdravilo Bovela, je bilo pet od 1 216 (0,4 %) novorojenih telet trajno okuženih z virusom, medtem ko je bilo v skupini, ki je prejela injekcijo brez zdravilne učinkovine, deset trajno okuženih novorojenih telet od skupno 1 183 (0,8 %).
It is available as a lyophilisate (freeze dried powder) and solvent for injection.
Na voljo je v obliki liofilizata (prašek, sušen z zamrzovanjem) in vehikla za injiciranje.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter se meso ali mleko uporabi za prehrano ljudi.
To prevent the birth of a PI calf the vaccine should be given at least three weeks before insemination/mating.
Da bi preprečili kotitev teleta s trajno okužbo, je treba živalim cepivo vbrizgati vsaj tri tedne pred oploditvijo/parjenjem.
Bovela contains two BVDV strains (or types) modified by deletion of parts of two genes so that they can no longer cause disease.
Zdravilo Bovela vsebuje dva seva oziroma tipa virusa goveje virusne diareje, ki so ga modificirali z izbrisom delov dveh genov, tako da ne more več povzročiti bolezni.
The effectiveness of Bovela was further investigated in the field in eight dairy cattle herds of which five of them had a history of BVD or persistent infection at the beginning of the study.
Učinkovitost zdravila Bovela so nadalje raziskovali na terenu pri osmih čredah krav molznic, pri čemer so v petih izmed teh čred ob začetku študije že beležili primere okužbe z govejo virusno diarejo ali primere trajne okužbe.
PI animals tend never to reach their productive potential, have reduced fertility and are more susceptible to other diseases.
Živali s trajno okužbo praviloma nikoli ne dosežejo svojega proizvodnega potenciala, so manj plodne in bolj dovzetne za druge bolezni.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
When Bovela is given to cattle the animals' immune system recognises the virus strains as ‘foreign' and makes antibodies against them.
Ko živali prejmejo zdravilo Bovela, njihov imunski sistem virusna seva prepozna kot „tujka“ in proti njima razvije protitelesa.
What is Bovela used for?
Za kaj se zdravilo Bovela uporablja?
Approximately half of the cattle were vaccinated with Bovela and the rest received a dummy injection.
Približno polovica goveda je bila cepljena s cepivom Bovela, ostale živali pa so prejele injekcijo brez zdravilne učinkovine.
This will help protect the cattle against BVD infections.
To bo pripomoglo k zaščiti goveda pred okužbami z govejo virusno diarejo.
In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
V laboratorijskih študijah je zdravilo Bovela preprečilo trajno okužbo pri 100 % telet, medtem ko so krave, ki niso prejele cepiva, skotile 100 % telet s trajno okužbo.
How has Bovela been studied?
Kako je bilo zdravilo Bovela raziskano?
They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth.
Njihova bolezen lahko napreduje v mukozno bolezen, ki je ena od oblik goveje virusne diareje, zaznamujejo pa jo razjede in mehurji na gobcu in v ustih.
In non-pregnant animals the infection is generally mild, with signs affecting the airways such as cough, and reduced milk yield.
Pri živalih, ki niso breje, je okužba na splošno blaga ter prizadene dihalne poti (kašelj) in zmanjšuje mlečnost.
However a severe form of BVD can occur, when cattle have a high temperature and bloody diarrhoea.
Pojavi se lahko tudi hujša oblika goveje virusne diareje, zaradi katere ima govedo povišano telesno temperaturo in krvavo drisko.
PI animals are a constant source of BVD virus, infecting other cattle in the herd.
Živali s trajno okužbo so nenehen vir virusa goveje virusne diareje in tako okužbo prenašajo na drugo govedo v čredi.
Bovela is used to protect cattle against BVD viral infection.
Zdravilo Bovela se uporablja za zaščito goveda pred okužbo z govejo virusno diarejo.
How does Bovela work?
Kako zdravilo Bovela deluje?
In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI).
Pri brejih kravah lahko okužba z govejo virusno diarejo povzroči splav ali kotitev telet s trajno okužbo.
The withdrawal period for Bovela for cattle is zero days.
Karenca za zdravilo Bovela za govedo je nič dni.
What is Bovela?
Kaj je zdravilo Bovela?
• If you are under 18 years of age.
• če ste mlajši od 18 let.
Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
Varnosti in učinkovitosti pri otrocih, mlajših od 18 let, še niso ugotovili.
• Apply the next dose as soon as possible.
• Nanesite naslednji odmerek takoj, ko je mogoče.
There are no known incompatibilities.
Ni znanih inkompatibilnosti.
• Are due to complications of diabetes.
• so posledica zapletov sladkorne bolezni.
• You have any severe or persistently worsening types of cancer
• imate hudo ali stalno napredujočo vrsto raka,
Use within 6 weeks after first opening.
Porabite v 6 tednih po prvem odpiranju.
• You have diseases of the arteries.
• imate bolezen, ki prizadane arterije.
Date opened:
Datum odpiranja:
If it is almost time for the next application, forget about the missed dose and continue as normal
Če je že skoraj čas za naslednji nanos, preskočite pozabljeni odmerek in nadaljujte kot normalno.
Date of latest renewal: 19 March 2009
Datum zadnjega podaljšanja dovoljenja za promet: 19. marec 2009
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
Further information
Dodatni podatki
Refers to erythema at the application site.
Nanaša se na eritem na mestu aplikacije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 March 1999
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 29. marec 1999
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
Always try to follow the instructions for use exactly.
Kljub temu pa skušajte vedno natančno upoštevati navodila za uporabo.
These 1883 patients had at least one topical administration of REGRANEX and provided safety data.
Pri teh 1.883 bolnikih so najmanj enkrat topikalno nanesli zdravilo REGRANEX in posredovali podatke o varnosti.
There are no adequate data from the use of becaplermin in pregnant women.
Ni zadostnih podatkov o uporabi bekaplermina pri nosečnicah.
• Excessive growth of new tissue at the wound (rare)
• prekomerno rast novega tkiva v razjedi (redko),
Pregnancy and breast-feeding • Do not use this medicine if you are pregnant, think you might be pregnant or planning to
Nosečnost in dojenje • Zdravila REGRANEX ne smete uporabljati če ste noseči, mislite, da ste noseči ali nameravate
• If you have or have had cancer
• če imate ali ste imeli rakavo obolenje,
There are insufficient data to support safe use of the product for more than 20 weeks (see 5.1 Pharmacodynamic properties).
Podatki, ki bi potrjevali varno uporabo zdravila dlje kot 20 tednov, so nezadostni (glejte poglavje 5.1 Farmakodinamične lastnosti).
REGRANEX 0.01% gel becaplermin
REGRANEX 0,01 % gel bekaplermin
MARKETING AUTHORISATION NUMBER(S) EU/1/99/101/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/101/001
Please record the date of opening on the tube label.
Datum odpiranja vpišite na nalepko na tubi.
REGRANEX is used for skin ulcers that:
Zdravilo REGRANEX se uporablja pri kožnih razjedah, ki:
• Keeping weight off your feet, perhaps by wearing special orthopaedic shoes or by other methods
• ukrepe za razbremenitev nog, morda uporabo posebnih ortopedskih čevljev ali druge ukrepe,
Gel in a multidose tube (15 gram).
Gel v tubi za večkratno odmerjanje (15 gramov).
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1.0 načrta za obvladovanje tveganja (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).