natgillin/translations-raw huggingface dataset:
In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body.
V korifolitropinu alfa je na FSH vezan peptid (kratka veriga aminokislin), da podaljša njegovo delovanje v telesu.
What is Elonvaand what is it used for?
Kaj je zdravilo Elonva in za kaj se uporablja?
The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body.
Učinkovina v zdravilu Elonva, korifolitropin alfa, je podobna naravnemu hormonu v telesu, in sicer folikle stimulirajočemu hormonu (FSH).
For the full list of side effects of Elonva, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Elonva glejte navodilo za uporabo.
As a result, a single dose of the medicine can be given to stimulate egg production for seven days, instead of daily injections that would be required with other FSH medicines.
Zato se lahko za enotedensko stimuliranje nastajanja jajčec injicira en odmerek zdravila, kar nadomesti vsakodnevne injekcije, ki bi bile potrebne pri zdravljenju z drugimi zdravili s FSH.
Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given.
Če je potrebno dodatno stimuliranje jajčnikov, se lahko sedem dni po injiciranju zdravila Elonva uporabi injekcija drugega zdravila, ki je podobno zdravilu Elonva, vendar je primerno za vsakodnevno injiciranje.
Elonva contains the active substance corifollitropin alfa.
Zdravilo Elonva vsebuje učinkovino korifolitropin alfa.
Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary (a gland located at the base of the brain that produces FSH) or hypothalamus (a region of the brain).
Zdravila Elonva ne smejo uporabljati bolnice s tumorji jajčnikov, dojk, maternice, hipofize (žleze na možganskem dnu, ki tvori FSH) ali hipotalamusa (predela v možganih).
Elonva is available as a solution for injection.
Na voljo je v obliki raztopine za injiciranje.
Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta.
Zanosilo je približno 39 % žensk, ki so prejele zdravilo Elonva, in 38 % žensk, ki so prejele folitropin beta.
How does Elonva work?
Kako zdravilo Elonva deluje?
One of the studies involved women weighing 60 kg or less who received a 100-microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150-microgram dose.
V eno od teh študij so bile vključene ženske s telesno maso pod 60 kg, ki so prejele 100-mikrogramski odmerek zdravila Elonva, v drugo pa ženske s telesno maso nad 60 kg, ki so prejele 150-mikrogramski odmerek.
How is Elonva used?
Kako se zdravilo Elonva uporablja?
Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early.
Zdravljenje z antagonistom GnRH, ki prepreči prezgodnjo sprostitev jajčec iz jajčnikov, se lahko prične štiri ali pet dni po injiciranju zdravila Elonva, odvisno od odziva jajčnikov.
In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with follitropin beta.
V prvi študiji, v kateri so sodelovale ženske s telesno maso 60 kg ali manj, so pri vsaki posameznici, ki se je zdravila z zdravilom Elonva, odvzeli 13,3 jajčeca, medtem ko so jih pri posameznicah, zdravljenih s folitropinom beta, odvzeli 10,6.
In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13.8 in those treated with Elonva compared with 12.6 in those treated with follitropin beta.
V drugi študiji pri ženskah s telesno maso nad 60 kg so tistim, ki so se zdravile z zdravilom Elonva, v povprečju odvzeli 13,8 jajčeca, tistim, ki so se zdravile s folitropinom beta, pa 12,6 jajčeca.
The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150-microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy, and 24 and 27% of women treated with Elonva and follitropin beta respectively became pregnant.
Glavno merilo učinkovitosti v tej študiji je bilo število žensk z uspešno zgodnjo nosečnostjo, zanosilo pa je 24 % žensk, ki so bile zdravljene z zdravilom Elonva, in 27 % žensk, zdravljenih s folitropinom beta.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
Hungary Baxter Hungary Kft. Népfürdő u. 22.
Madžarskem Baxter Hungary Kft. Népfürdö u. 22.
Romania BAXTER d.o.o.
Romunije BAXTER d.o.o.
Poland Baxter Polska SP. z o.o.
Poljskem Baxter Polska SP. z.o.o.
Netherlands Baxter B.V., Kobaltweg 49, 3542
Nizozemsko Baxter B.V Kobaltweg 49
Baxter AS Gjerdrumsvei 11 0484 Oslo, Norway
0484 Oslo, Norway
Italy
Italijo
Greece
Grčijo
Baxter MédicoFarmacêutica, Lda.
Portugalskem Baxter Médico Farmacêutica Lda
FINLAND
Finsko
4 to 1,1% acides aminés
4 to 1,1% aminokisline
Romania BAXTER HEALTHCARE Ltd.,
Romunije Baxter Healthcare Ltd Caxton Way,
13.60 g/l glucose anhydrate
13.60 g/l Brezvodna glukoza
Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Romunije Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland
Anhydrous glucose 38.6 g/L, sodium chloride 5.67 g/L, sodium lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Brezvodna glukoza 38.6 g/L, natrijev klorid 5.67 g/L, natrijev S laktat 3.92 g/L, kalcijev klorid 0,257 g/L, magnezijev klorid 0,152 g/L
Anhydrous glucose 13.6 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Brezvodna glukoza 13.6 g/L, natrijev klorid 5.67 g/L, natrijev S laktat 3.92 g/L, kalcijev klorid 0,257 g/L, magnezijev klorid 0,152 g/L
Anhydrous glucose 22.7 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Brezvodna glukoza 22.7 g/L, natrijev klorid 5.67 g/L, natrijev S laktat 3.92 g/L, kalcijev klorid 0,257 g/L, magnezijev klorid 0,152 g/L
Castelbar, County
Warszawa, Poland
The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Aptivus, veljavno po vsej Evropski uniji, izdala 25. oktobra 2005.
Other information about Aptivus:
Druge informacije o zdravilu Aptivus:
The full EPAR for Aptivus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aptivus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Aptivus?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aptivus?
It is available as capsules (250 mg) and as an oral solution.
Na voljo je v kapsulah (250 mg) in kot peroralna raztopina.
In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Pri bolnikih, starejših od 12 let, je priporočeni odmerek zdravila Aptivus 500 mg (dve kapsuli) dvakrat na dan.
The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment.
Glavni merili učinkovitosti sta bili število bolnikov, ki so se odzvali na zdravljenje, in čas, dokler zdravilo ni prenehalo delovati, v prvih 48 tednih zdravljenja.
A risk management plan has been developed to ensure that Aptivus is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Aptivus je bil pripravljen načrt obvladovanja tveganj.
This document is a summary of the European public assessment report (EPAR) for Aptivus.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aptivus.
The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.
V študiji so proučevali varnost in učinkovitost zdravila Aptivus ter ravni zdravila v bolnikovi krvi.
The dose of the oral solution depends on body surface area (calculated using the child's height and weight).
Odmerek peroralne raztopine je odvisen od površine telesa (izračunano glede na otrokovo telesno višino in maso).
A ‘response' was defined as a fall in the levels of HIV in the blood (viral load) by 90% or more that was maintained until the end of the 48 weeks.
Odziv je bil opredeljen kot padec ravni virusa HIV v krvi (virusna obremenitev) za 90 % ali več, ki se je ohranil do konca 48 tednov.
For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aptivus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Each dose of Aptivus must be taken with ritonavir and food.
Vsak odmerek zdravila Aptivus je treba vzeti sočasno z ritonavirjem in hrano.
What benefit has Aptivus shown during the studies?
Kakšne koristi je zdravilo Aptivus izkazalo med študijami?
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Ko je encim zavrt, se virus ne more več normalno razmnoževati, kar upočasni širjenje okužbe.
Children aged between two and 12 years should use the oral solution.
Otroci, stari od dve do 12 let, morajo uporabljati peroralno raztopino.
All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks.
Vsi bolniki so zdravljenje začeli s peroralno raztopino, mladostniki, ki so jemali polni odmerek za odrasle, pa so lahko po štirih tednih prešli na jemanje kapsul.
Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Zdravljenje z zdravilom Aptivus mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV-1.
However, it concluded that the medicine should only be considered for use as ‘last line' therapy, when no other protease inhibitors are predicted to work.
Kljub temu pa je zaključil, da je treba zdravilo obravnavati le kot „zadnjo možnost“ zdravljenja, ko se predvideva, da noben drug zaviralec proteaze ne bo deloval.
The CHMP noted that the studies supported the use of Aptivus capsules in adults.
CHMP je menil, da študije podpirajo uporabo kapsul zdravila Aptivus pri odraslih.
• medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
• zdravila, katerih presnova poteka enako kot presnova zdravila Aptivus ali ritonavirja ter so škodljiva, kadar so njihove ravni v krvi visoke.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aptivus.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Aptivus should only be used in patients who have no other treatment options.
Zdravilo Aptivus se lahko uporablja samo pri bolnikih, za katere ne obstaja nobena druga možnost zdravljenja.
This was compared with an average of zero days in those taking the comparator, meaning that most of the patients taking the comparator did not respond to their treatment at all.
To so primerjali s povprečno nič dnevi pri tistih bolnikih, ki so jemali primerjalno zdravilo, kar pomeni, da se večina bolnikov, ki je jemala primerjalno zdravilo, sploh ni odzvala na zdravljenje.
In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.
V študiji z otroki in mladostniki je 31 % mladostnikov, ki so jemali kapsule (9 mladostnikov od 29), in 50 % otrok, ki so jemali peroralno raztopino (31 otrok od 62), po 48 tednih doseglo in ohranilo virusno obremenitev pod 400 kopijami/ml.
Aptivus does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Aptivus ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737).
V obeh študijah z odraslimi bolniki se je na zdravljenje skupaj odzvalo 34 % bolnikov, ki so jemali zdravilo Aptivus (251 bolnikov od 746), v primerjavi s 16 % bolnikov, ki so jemali primerjalne zaviralce proteaze (113 bolnikov od 737).
What is the risk associated with Aptivus?
Kakšna tveganja so povezana z zdravilom Aptivus?
Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past.
Zdravilo Aptivus so prav tako raziskovali v eni študiji, v katero je bilo vključenih 63 otrok, starih od dve do 12 let, in 52 mladostnikov, starih od 12 do 18 let, od katerih so skoraj vsi v preteklosti prejemali zdravila za zdravljenje okužbe z virusom HIV.
Although the Committee had some concerns over how the study in children and adolescents was designed, the Committee noted that its results supported the use of the capsules in adolescents and the oral solution in children between the ages of two and 12 years.
Čeprav je imel Odbor določene zadržke glede zasnove študije pri otrocih in mladostnikih, je ugotovil, da rezultati študije podpirajo uporabo kapsul pri mladostnikih in peroralne raztopine pri otrocih, starih od dveh in 12 let.
Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Podobni neželeni učinki so bili opaženi pri otrocih in mladostnikih, čeprav so bili bruhanje, izpuščaji in pireksija (povišana telesna temperatura) opaženi pogosteje kot pri odraslih.
Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Aptivus se uporablja za zdravljenje bolnikov, starejših od dveh let, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Aptivus with ritonavir must not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines:
Prav tako se v kombinaciji z ritonavirjem ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z jetri oziroma ki jemljejo katero od naslednjih zdravil:
Both studies compared the effects of Aptivus with those of another protease inhibitor that was chosen on the basis of the patient's previous treatments and predicted response.
V obeh študijah so primerjali učinke zdravila Aptivus z učinki drugega zaviralca proteaze, izbranega na podlagi bolnikovih predhodnih zdravljenj in predvidenega odziva.
The Committee recommended that Aptivus be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Aptivus izda dovoljenje za promet.
It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work.
Uporablja se pri bolnikih, ki so se zaradi okužbe z virusom HIV že zdravili z drugimi protivirusnimi zdravili in pri katerih številna zdravila istega razreda kot zdravilo Aptivus (zaviralci proteaze) ne učinkujejo.
Doctors should only prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and the likelihood that the virus will respond to the medicine.
Zdravniki smejo zdravilo Aptivus predpisati šele potem, ko se seznanijo z zdravili za zdravljenje okužbe z virusom HIV, ki jih je bolnik jemal prej, in verjetnostjo, da se bo virus odzval na zdravilo.
Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor.
Kapsule zdravila Aptivus so proučevali v dveh glavnih študijah, v kateri je bilo skupaj vključenih 1 483 odraslih, ki so v preteklosti prejemali številna različna zdravila proti okužbi z virusom HIV, vendar se na svojo trenutno terapevtsko kombinacijo, ki je vključevala zaviralec proteaze, niso odzivali.
It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
Ta upočasnjuje hitrost razgradnje tipranavirja in povečuje njegovo raven v krvi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.
V vseh treh študijah so bolniki jemali tudi ritonavir in kombinacijo drugih zdravil za zdravljenje okužbe z virusom HIV, izbranih tako, da so obetala največjo verjetnost za zmanjšanje ravni virusa HIV v krvi.
Aptivus is a medicine that contains the active substance tipranavir.
Aptivus je zdravilo, ki vsebuje zdravilno učinkovino tipranavir.
However, the available information does not support the use of the oral solution in patients aged 12 years or above.
Vendar pa ni bilo zadostnih podatkov, ki bi podprli uporabo peroralne raztopine pri bolnikih, starejših od 12 let.
Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Če zdravilo Aptivus jemljemo v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV, to zmanjša količino tega virusa v krvi in ga ohranja na nizki ravni.
For the full list of all side effects reported with Aptivus, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aptivus, glejte navodilo za uporabo.
This allows a lower dose of tipranavir to be used for the same antiviral effect.
Tako za enak protivirusni učinek zadošča manjši odmerek tipranavirja.
In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Pri odraslih bolnikih sta najpogostejša neželena učinka pri jemanju zdravila Aptivus sočasno z ritonavirjem (opažena pri več kot 1 bolniku od 10) driska in navzeja (slabost).
The active substance in Aptivus, tipranavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Aptivus, tipranavir, je zaviralec proteaze.
On average, it took 113 days for treatment to stop working in adults taking Aptivus.
V povprečju je zdravljenje pri bolnikih, ki so jemali zdravilo Aptivus, prenehalo delovati po 113 dneh.
Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment.
Zdravilo Aptivus, dajano v kombinaciji z ritonavirjem, je bilo pri bolnikih z le malo preostalimi možnostmi za uspešno zdravljenje okužbe z virusom HIV učinkovitejše od primerjalnih zdravil.
Why has Aptivus been approved?
Zakaj je bilo zdravilo Aptivus odobreno?
Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Zdravilo se uporablja v kombinaciji z nizkim odmerkom ritonavirja (drugega zdravila za zdravljenje okužbe z virusom HIV) in drugimi zdravili za zdravljenje okužbe z virusom HIV.
Therefore, the CHMP decided that the benefits of Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of age or older.
Zato je sklenil, da so koristi kapsul Aptivus za zdravljenje odraslih in mladostnikov, starejših od 12 let, večje od z njim povezanih tveganj.
Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment.
Zdravilo Aptivus v kombinaciji z ritonavirjem se ne sme jemati sočasno kolhicinom (zdravilom za zdravljenje protina) pri bolnikih z okvaro ledvic ali jeter.
The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age.
Prav tako je menil, da so koristi peroralne raztopine Aptivus pri otrocih, starih od dveh do 12 let, večje od z njim povezanih tveganj.
What is Aptivus used for?
Za kaj se zdravilo Aptivus uporablja?
How has Aptivus been studied?
Kako je bilo zdravilo Aptivus raziskano?
How is Aptivus used?
Kako se zdravilo Aptivus uporablja?
What is Aptivus?
Kaj je zdravilo Aptivus?
EMA/CHMP/800910/2012 EMEA/H/C/002610
13. december 2012 EMA/130427/2013 EMEA/H/C/002610
EMA/CHMP/800910/2012
EMA/130427/2013
The initial concerns related mainly to the manufacture of the medicine and whether Isomarv medium was sufficiently similar to its reference medicine.
Prvotni pomisleki so bili v glavnem povezani s proizvodnjo zdravila in z vprašanjem, ali je zdravilo Isomarv medium dovolj podobno referenčnemu zdravilu.
The insulin in Isomarv medium is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Insulin v zdravilu Isomarv medium se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdela ga bakterija, ki je prejela gen (DNK), s pomočjo katerega lahko tvori insulin.
On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Isomarv medium, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Družba Marvel LifeSciences Ltd je dne 15. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Isomarv medium, namenjenim zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze v krvi.
The company informed the CHMP that at the time of the withdrawal no patients were receiving Isomarv medium in clinical trials.
Družba je CHMP obvestila, da v času umika vloge ni bilo bolnikov, ki bi v kliničnih študijah prejemali zdravilo Isomarv medium.
After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Isomarv medium could not have been approved.
Po oceni začetne dokumentacije je CHMP izrazil velike zadržke in je začasno menil, da zdravila Isomarv medium ni mogoče odobriti.