natgillin/translations-raw huggingface dataset:
In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18), compared with 18% of those who received the standard formulation of cytarabine (3 out of 17).
V glavni študiji se je 72 % (13 od 18) bolnikov, ki so prejemali zdravilo DepoCyte odzvalo na zdravljenje, v primerjavi z 18 % (3 od 17) tistih, ki so prejemali standardno obliko citarabina.
For more information about treatment with DepoCyte, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom DepoCyte preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The study also looked at how long the patients lived without their nerve disease getting worse.
V študiji so opazovali tudi, kako dolgo so bolniki živeli, ne da bi se obolenje živcev poslabšalo.
What benefit has DepoCyte shown during the studies?
Kakšne koristi je zdravilo DepoCyte izkazalo med študijami?
As a result, cytarabine slows down the growth of tumour cells and eventually kills them.
Posledično citarabin upočasni rast tumorskih celic in jih sčasoma tudi ubije.
However, there was no difference between the two medicines in how long the patients lived without their nerve disease getting worse.
Vendar pa ni bilo med zdraviloma nobenih razlik glede tega, koliko časa so bolniki živeli, ne da bi se jim obolenje živcev poslabšalo.
These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory problems, incontinence and unusual sensations.
Ti simptomi največkrat prizadenejo živce in vključujejo bolečino, krče, glavobol, težave pri hoji, težave s spominom, inkontinenco in nenavadne občutke.
DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines.
Zdravilo DepoCyte lahko predpiše le zdravnik, ki ima izkušnje z zdravili proti raku.
The Committee decided that DepoCyte's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila DepoCyte večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
DepoCyte helps to control the symptoms of the disease.
Zdravilo DepoCyte pomaga obvladovati simptome bolezni.
What is the risk associated with DepoCyte?
Kakšna tveganja so povezana z zdravilom DepoCyte?
DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly).
DepoCyte je injekcija „na zalogo“ (vrsta injekcije, v kateri je zdravilo pripravljeno tako, da ga telo vsrkava zelo počasi).
The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that has been used since the 1970s.
Zdravilna učinkovina v zdravilu DepoCyte, citarabin (znan tudi kot ara-C), je učinkovina proti raku, ki se uporablja že od sedemdesetih let prejšnjega stoletja.
It must not be used in patients who have an active infection in the meninges.
Ne sme se uporabljati pri osebah, ki imajo aktivno vnetje mening.
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 DepoCyte.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo DepoCyte, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a further 50 mg four weeks later.
Prvih pet odmerkov zdravila DepoCyte se na začetku daje kot 50-miligramska injekcija vsake dva tedna, ki jim štiri tedne kasneje sledi še nadaljnji 50-miligramski odmerek.
DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of the other ingredients.
Zdravila DepoCyte ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) citarabin ali katero koli drugo sestavino zdravila.
The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects.
Bolnik mora prejeti tudi deksametazon (steroid), ki pomagajo pri nadzoru nekaterih neželenih učinkov.
DepoCyte is used to treat lymphomatous meningitis.
Zdravilo DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa.
Cytarabine is an analogue of pyrimidine.
Citarabin je analog pirimidina.
The dose can be decreased to 25 mg if the patient shows signs of damage to the nerves (such as headache, abnormal vision, muscle weakness or pain).
Odmerek se nato lahko zmanjša na 25 mg, čebolnik kaže znake poškodbe živcev (kot so glavobol, neobičajen vid ali šibkost oziroma bolečine v mišicah).
The medicine must be injected ‘intrathecally' (directly into the spinal fluid in the space that surrounds the spinal cord and the brain).
Zdravilo mora biti injicirano „intratekalno“ (neposredno v spinalno tekočino v prostor, ki obkroža hrbtenjačo in možgane).
DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis.
Zdravilo DepoCyte je bilo primerjano s standardno obliko citarabina v eni glavni študiji z 35 bolniki z limfomatoznim meningitisom.
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients' quality of life because fewer intrathecal injections are needed.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo DepoCyte izkazalo učinkovitost pri limfomatoznem meningitisu v primerjavi s standardno obliko citarabina ter da lahko prispeva k izboljšanju kakovosti bolnikovega življenja, saj je potrebnih manj intratekalnih injekcij.
In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the production of new DNA.
Citarabin v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri izdelavi nove DNK.
For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila DepoCyte, glejte navodilo za uporabo.
In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly.
V zdravilu DepoCryte je citarabin vsebovan v liposomih (majhni maščobni delci), iz katerih se zdravilo počasi sprošča.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the ‘anti-metabolite' group.
Je citotoksin (zdravilo, ki ubija deleče se celice, kot so rakaste celice), ki spada v skupino antimetabolitov.
Why has DepoCyte been approved?
Zakaj je bilo zdravilo DepoCyte odobreno?
DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine.
Zdravilo DepoCyte je suspenzija za injiciranje, ki vsebuje 50 mg zdravilne učinkovine citarabin.
This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord).
To je obolenje, pri katerem so se tumorske celice limfoma (tumorja v limfnem sistemu) razširile v spinalno tekočino in na meninge (membrane, ki obdajajo možgane in hrbtenjačo).
The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored.
Najpogostejši neželeni učinki zdravila DepoCyte (opaženi v več kot enem ciklu zdravljenja od 10) so glavobol, arahnoiditis (vnetje ene od membrane, ki varujejo hrbtenjačo in možgane), zmedenost, slabost, bruhanje, driska, preksija (povišana telesna temperatura), šibkost in trombocitopenija (nizke ravni trombocitov v krvi).
The full EPAR for DepoCyte can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo DepoCyte je na voljo tukaj.
This is then followed by maintenance doses of 50 mg every four weeks for a further four doses.
miligramski vzdrževalni odmerki vsake štiri tedne.
What is DepoCyte used for?
Za kaj se zdravilo DepoCyte uporablja ?
How has DepoCyte been studied?
Kako je bilo zdravilo DepoCyte raziskano?
How is DepoCyte used?
Kako se zdravilo DepoCyte uporablja?
What is DepoCyte?
Kaj je zdravilo DepoCyte?
How does DepoCyte work?
Kako zdravilo DepoCyte deluje?
28 x 1 tablets
98 tablets
Invented name Strength
Izmišljeni ime Jakost
Pharmaceutical Form Route of Administration Packaging
Farmacevtska oblika Pot uporabe
Dose adjustments might be necessary in these patients.
Pri teh bolnikih bo morda potrebna prilagoditev odmerka.
Gabapentin has been associated with severe respiratory depression.
Gabapentin je bil povezan s hudo respiratorno depresijo.
Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814)
Gabapentin - respiratorna depresija brez sočasne uporabe opioidov (EPITT št. 18814)
Adopted at the 6-9 June 2017 PRAC
Sprejeto na seji odbora PRAC med 6. in 9. junijem 2017
What you need to know before you take <brand name> Warnings and precautions
Kaj morate vedeti, preden boste vzeli zdravilo <lastniško ime> Opozorila in previdnostni ukrepi
- if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
− če imate bolezni živčnega sistema, bolezni dihal ali ste stari več kot 65 let, vam bo zdravnik morda predpisal drugačno shemo odmerjanja
Respiratory depression
Dihalna depresija
In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Zlasti obvestite zdravnika (ali farmacevta), če jemljete ali ste pred kratkim jemali zdravila proti epileptičnim krčem (konvulzijam), motnjam spanja, depresiji, tesnobi ali kateri koli drugi nevrološki ali duševni motnji.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
Takoj obvestite zdravnika, če po jemanju zdravila opazite katerega koli od naslednjih simptomov, saj lahko predstavljajo resno stanje:
Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction.
Bolniki z zmanjšano respiratorno funkcijo, boleznimi dihal ali nevrološkimi boleznimi, okvaro ledvic, sočasno uporabo zaviralcev osrednjega živčevja in starejši ljudje so lahko izpostavljeni večjemu tveganju za pojav tega hudega neželenega učinka.
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/337624/2017
Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/388994/2017
Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogostnost: „redki“: Respiratorna depresija
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
− težave z dihanjem, pri katerih boste morda v primeru, da se pojavijo v hudi obliki, za vzpostavitev normalnega dihanja potrebovali nujno zdravniško pomoč in intenzivno nego
Summary of product characteristics 4.4.
Povzetek glavnih značilnosti zdravila
Special warnings and precautions for use Concomitant use with opioids
Posebna opozorila in previdnostni ukrepi
Talk to your doctor or pharmacist before taking <brand name>
Pred začetkom jemanja zdravila <lastniško ime> se posvetujte z zdravnikom ali farmacevtom
Rare (may affect up to 1 in 1,000 people):
Redki (pojavijo se lahko pri največ 1 od 1 000 bolnikov): − težave z dihanjem, plitvo dihanje (respiratorna depresija)
Powder for concentrate for solution for infusion
5 mg prašek za koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo)
Pack size
Mylotarg
The patches should not be cut into pieces.
Ne smejo se rezati na manjše koščke.
The patches can be worn during bathing and hot weather.
Obliži se lahko nosijo med kopanjem in v vročem vremenu.
Treatment should be continued for as long as the patient benefits from it.
Zdravljenje je treba nadaljevati, dokler ima bolnik od njega koristi.
The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Obliže je treba prilepiti na čisto, suho, neporaščeno in nepoškodovano kožo na hrbtu, nadlakti ali prsih in zamenjati vsakih 24 ur.
Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Zdravljenje je treba nadaljevati, dokler ima zdravilo koristi, vendar se lahko odmerek zmanjša ali zdravljenje prekine, če se pri bolniku pojavijo neželeni učinki.
They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Ne smejo se prilepiti na razdraženo ali pordelo kožo, na stegno ali trebuh in na predele, kjer bi se drgnili ob tesna oblačila.
The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd 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) in povzetek načrta obvladovanja tveganj za zdravilo Rivastigmin 3M Health Care Ltd sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care Ltd.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rivastigmin 3M Health Care Ltd.
Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated.
Zdravljenje je treba začeti z obližem, ki v 24 urah sprosti 4,6 mg učinkovine, po najmanj štirih tednih pa je treba odmerek povečati na 9,5 mg/24 ur z uporabo obliža večje jakosti, če bolnik manjši odmerek dobro prenaša.
In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Pri bolnikih z Alzheimerjevo demenco nekatere živčne celice v možganih odmrejo, zaradi česar se znižajo ravni živčnega prenašalca acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo
Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours.
Izdaja zdravila Rivastigmin 3M Health Care Ltd je le na recept, na voljo pa je v obliki transdermalnih obližev, ki v 24 urah skozi kožo sprostijo 4,6 ali 9,5 mg rivastigmina.
Treatment with Rivastigmine 3M Health Care Ltd should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's dementia.
Zdravljenje z zdravilom Rivastigmin 3M Health Care Ltd mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve demence.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine 3M Health Care Ltd has been shown to have comparable quality and to be bioequivalent to Exelon.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Rivastigmin 3M Health Care Ltd primerljivo raven kakovosti kot referenčno zdravilo Exelon ter da mu je biološko enakovredno.
Because Rivastigmine 3M Health Care Ltd is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Rivastigmin 3M Health Care Ltd generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Rivastigmine 3M Health Care Ltd be approved for use in the EU.
Priporočil je, da se zdravilo Rivastigmin 3M Health Care Ltd odobri za uporabo v EU.
This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Exelon.
Patients can be switched from rivastigmine capsules or oral solution to the patches.
Bolniki, ki jemljejo kapsule ali peroralno raztopino rivastigmina, lahko preidejo na zdravljenje z obliži.
What measures are being taken to ensure the safe and effective use of Rivastigmine 3M Health Care Ltd?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rivastigmin 3M Health Care Ltd?
For more information about treatment with Rivastigmine 3M Health Care Ltd, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rivastigmin 3M Health Care Ltd preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Rivastigmine 3M Health Care Ltd is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Uporablja se za zdravljenje bolnikov z blago do zmerno hudo Alzheimerjevo demenco, tj. napredujočo možgansko boleznijo, ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Rivastigmine 3M Health Care Ltd by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno dajal zdravilo Rivastigmin 3M Health Care Ltd in spremljal njegovo uporabo pri bolniku.
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014.
Evropska komisija je dovoljenje za promet z zdravilom Rivastigmin 3M Health Care Ltd, veljavno po vsej Evropski uniji, izdala 03. aprila 2014.
The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Zdravilna učinkovina v zdravilu Rivastigmin 3M Health Care Ltd, rivastigmin, deluje tako, da zavira encime, ki razgrajujejo acetilholin: acetilholinesterazo in butirilholinesterazo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rivastigmine 3M Health Care Ltd, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Rivastigmin 3M Health Care Ltd in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Rivastigmine 3M Health Care Ltd is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Ker je zdravilo Rivastigmin 3M Health Care Ltd generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Exelon.
Other information about Rivastigmine 3M Health Care Ltd
Druge informacije o zdravilu Rivastigmin 3M Health Care Ltd
By blocking these enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia.
Zdravilo Rivastigmin 3M Health Care Ltd z zaviranjem teh encimov povzroči, da se ravni acetilholina v možganih zvišajo, zaradi česar se simptomi Alzheimerjeve demence ublažijo.
Rivastigmine 3M Health Care Ltd is a medicine that contains the active substance rivastigmine.
Rivastigmin 3M Health Care Ltd je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
For practical information about using Rivastigmine 3M Health Care Ltd, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Rivastigmin 3M Health Care Ltd naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Exelon odtehtajo znana tveganja.
A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Rivastigmin 3M Health Care Ltd je bil pripravljen načrt obvladovanja tveganj.
Rivastigmine 3M Health Care Ltd is a ‘generic medicine'.
Zdravilo Rivastigmin 3M Health Care Ltd je „generično zdravilo“.
What is Rivastigmine 3M Health Care Ltd and what is it used for?
Kaj je zdravilo Rivastigmin 3M Health Care Ltd in za kaj se uporablja?
What are the benefits and risks of Rivastigmine 3M Health Care Ltd?
Kakšne so koristi in tveganja, povezani z zdravilom Rivastigmin 3M Health
Why is Rivastigmine 3M Health Care Ltd approved?
Zakaj je bilo zdravilo Rivastigmin 3M Health Care Ltd odobreno?
The full EPAR for the reference medicine can also be found on the Agency's website.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za referenčno zdravilo je tudi na voljo na
How does Rivastigmine 3M Health Care Ltd work?
Kako zdravilo Rivastigmin 3M Health Care Ltd deluje?
How has Rivastigmine 3M Health Care Ltd been studied?
Kako je bilo zdravilo Rivastigmin 3M Health Care Ltd raziskano?
How is Rivastigmine 3M Health Care Ltd used?
Kako se zdravilo Rivastigmin 3M Health Care Ltd uporablja?
Article 35 of Directive 2001/82/EC, as amended.
Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
The CVMP was requested to give its opinion on the matter.
CVMP je bil naprošen, da o zadevi izrazi svoje mnenje.
International Non-Proprietary Name (INN): Ivermectin
Mednarodno nelastniško ime (INN): ivermektin
The final opinion was converted into a Decision by the European Commission on 1 October 2009.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 1 oktobra 2009.
1 October 2009 Doc.
1 oktober 2009 Sklic dok.
The referral procedure started on 16 January 2008.
Napotitveni postopek se je začel 16. januarja 2008.
Ref. EMEA/471056/2009
: EMEA/471056/2009
The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure.
Predložene informacije so zadevale 173 od 293 dovoljenj za promet, ki jih obravnava zadevni napotitveni postopek.
On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request.
9. decembra 2008 in 14. januarja 2009 sta dva imetnika dovoljenj za promet na njihovo zahtevo podala ustna pojasnila.
On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations.
4. junija 2008 so bili nacionalni pristojni organi držav članic naprošeni, naj priskrbijo manjkajoče informacije za preostalih 120 dovoljenj za promet.