natgillin/translations-raw huggingface dataset:
It also attaches to a protein (CD3) on T cells (another type of white blood cell).
Veže se tudi na beljakovino (CD3) na celicah T (drugi vrsti belih krvnih celic).
Other information about Blincyto
Druge informacije o zdravilu Blincyto
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blincyto have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Blincyto upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients lived for an average of around 6 months before the cancer came back, which could enable suitable patients to have a blood stem cell transplant.
Bolniki so pred ponovitvijo raka povprečno živeli približno šest mesecev, kar bi lahko primernim bolnikom omogočilo prejem presadka matičnih krvnih celic.
The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infections, fever, infusion-related reactions (like fever, changes in blood pressure and rash), headache, febrile neutropenia (low levels a type of white blood cell counts called neutrophils with fever), anaemia (low red blood cell counts), oedema (swelling because of fluid retention), neutropenia, leukopenia (low levels of white blood cell), thrombocytopenia (low platelet count), blood tests showing changes in liver function, tremor (shaking), back pain, chills, low blood pressure, low levels of immunoglobulins (antibodies), cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), rapid heartbeat, insomnia (difficulty sleeping), pain in the arms and legs, cough and rash.
Najpogostejši neželeni učinki zdravila Blincyto (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe, zvišana telesna temperatura, infuzijske reakcije (kot so zvišana telesna temperatura, spremembe krvnega tlaka in izpuščaj), glavobol, febrilna nevtropenija (nizke vrednosti vrste belih krvnih celic, imenovanih nevtrofilci, skupaj s povišano telesno temperaturo), anemija (nizke ravni rdečih krvnih celic), edem (otekanje zaradi zastajanja tekočine), nevtropenija, levkopenija (nizke ravni belih krvnih celic), trombocitopenija (nizke ravni trombocitov), rezultati krvnih preiskav, ki kažejo na spremembe delovanja jeter, tremor (tresenje), bolečine v hrbtu, mrzlica, nizek krvni tlak, nizke vrednosti imunoglobulinov (protiteles), sindrom sproščanja citokinov (možno smrtno nevarno stanje, ki lahko povzroči zvišano telesno temperaturo, bruhanje, zasoplost, bolečino in nizek krvni tlak), hiter srčni utrip, nespečnost (težave s spanjem), bolečine v rokah in nogah, kašelj in izpuščaj.
Side effects reported with Blincyto are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Blincyto, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Blincyto, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Blincyto glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Results showed that around 78% of patients did not have measurable residual cancer cells after treatment with Blincyto.
Rezultati so pokazali, da približno 78 % bolnikov po zdravljenju z zdravilom Blincyto ni imelo merljivih rezidualnih rakavih celic.
What benefits of Blincyto have been shown in studies?
Kakšne koristi zdravila Blincyto so se pokazale v študijah?
The study found that ALL improved in 43% (81 out of 189) of patients given Blincyto.
V študiji je bilo ugotovljeno, da se je stanje akutne limfoblastne levkemije izboljšalo pri 43 % (81 od 189) bolnikov, ki so prejemali zdravilo Blincyto.
An overview of Blincyto and why it is authorised in the EU
Pregled zdravila Blincyto in zakaj je odobreno v EU
Blincyto was given ‘conditional approval' but the company has provided more evidence about the medicine and the Agency has recommended that the Blincyto's marketing authorisation should no longer be conditional.
Zdravilo Blincyto je pridobilo „pogojno dovoljenje za promet“, vendar je podjetje zagotovilo več dokazov o zdravilu, zato je agencija priporočila, naj se dovoljenje za promet z zdravilom Blincyto iz pogojnega spremeni v običajno.
The safety profile of Blincyto was considered acceptable provided that recommendations on its use are observed.
Navedla je, da je varnostni profil zdravila Blincyto sprejemljiv ob upoštevanju priporočil za njegovo uporabo.
Why is Blincyto authorised in the EU?
Zakaj je bilo zdravilo Blincyto odobreno v EU?
In this study, Blincyto was not compared with any other treatment.
V tej študiji zdravila Blincyto niso primerjali z nobenim drugim zdravilom.
For treatment of patients with minimal residual disease, the dose depends on the patient's bodyweight.
Pri zdravljenju bolnikov z minimalno rezidualno boleznijo je odmerek odvisen od bolnikove telesne mase.
What are the risks associated with Blincyto?
Kakšna tveganja so povezana z zdravilom Blincyto?
Patients who have no signs of cancer after 2 cycles may be treated with up to 3 additional cycles of Blincyto if the benefits outweigh the risks for the patient.
Bolniki, ki po dveh ciklusih zdravljenja nimajo znakov raka, lahko prejmejo do tri dodatne cikluse zdravljenja z zdravilom Blincyto, če pri posameznem bolniku koristi odtehtajo tveganja.
The company will also provide patients and healthcare professionals with educational materials on how to give Blincyto and how to manage risks with the medicine.
Bolnikom in zdravstvenim delavcem bo tudi zagotovilo izobraževalno gradivo o dajanju tega zdravila ter o obvladovanju tveganj, povezanih z njim.
Patients should also be given chemotherapy medicines injected in the spine area to prevent leukaemia in the nervous system.
Bolnikom je prav tako treba v hrbtenico injicirati kemoterapevtska zdravila, da bi preprečili levkemijo v živčevju.
ALL is rare, and Blincyto was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Akutna limfoblastna levkemija je redka bolezen, zato je bilo zdravilo Blincyto 24. julija 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What is Blincyto and what is it used for?
Kaj je zdravilo Blincyto in za kaj se uporablja?
In most patients whose ALL improved, there was no evidence of cancer cells left.
Pri večini bolnikov, pri katerih se je stanje akutne limfoblastne levkemije izboljšalo, ni bilo znakov preostalih rakavih celic.
The most serious side effects were infections, neutropenia with or without fever, neurological events (such as confusion, shaking, dizziness, numbness or tingling), cytokine release syndrome, and tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Med najresnejšimi neželenimi učinki so bili okužbe, nevtropenija z zvišano telesno temperaturo ali brez nje, nevrološki dogodki (kot so zmedenost, tresenje, omotičnost, omrtvelost ali mravljinčenje), sindrom sproščanja citokinov in sindrom lize tumorja (zaplet zaradi razgradnje rakavih celic).
Blincyto is used in patients who are ‘Philadelphia-chromosome-negative' which means that the patients' cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).
Zdravilo Blincyto se uporablja pri bolnikih z negativnim kromosomom Philadelphia, kar pomeni, da rakave celice pri teh bolnikih nimajo nenormalnega kromosoma, imenovanega kromosom Philadelphia, in pri bolnikih, ki imajo na svojih rakavih celicah beljakovino CD19 (CD19-pozitivni).
Blincyto can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Predpisovanje in izdaja zdravila Blincyto je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
In B-precursor ALL, certain cells that give rise to B cells (a type of white blood cell) multiply too quickly and eventually these abnormal cells replace normal blood cells.
Pri akutni limfoblastni levkemiji predhodniških celic B se nekatere celice, iz katerih nastajajo celice B (vrsta belih krvnih celic), razmnožujejo prehitro, zaradi česar te nenormalne celice sčasoma nadomestijo normalne krvne celice.
The main measure of effectiveness was based on the percentage of patients whose ALL improved after 2 treatment cycles, measured as resolution of signs of leukaemia and complete or partial return of blood cell counts to normal.
Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, pri katerih se je stanje akutne limfoblastne levkemije izboljšalo po dveh ciklusih zdravljenja, kar je bilo merjeno kot izginotje znakov levkemije in popolna oziroma delna normalizacija števila krvničk.
Before receiving Blincyto, patients should be given medicines to prevent fever and reactions to the infusion.
Bolniki morajo pred prejemom zdravila Blincyto prejeti zdravila za preprečevanje zvišane telesne temperature in reakcij na infundiranje.
Blincyto is infused continuously during a treatment cycle of 4 weeks.
Zdravilo Blincyto se infundira neprestano med celotnim štiritedenskim ciklusom zdravljenja.
The active substance in Blincyto, blinatumomab, is an antibody that has been designed to attach to a protein (CD19) found on B cells, including ALL cells.
Učinkovina v zdravilu Blincyto, blinatumomab, je protitelo, ki je bilo zasnovano tako, da se veže na beljakovino (CD19) na celicah B, vključno s celicami ALL.
Patients may be treated for up to 3 additional treatment cycles, each one given after a 2-week treatment-free interval.
Bolniki se lahko zdravijo z največ tremi dodatnimi ciklusi, vsakega od katerih prejmejo po dvotedenskem premoru brez zdravljenja.
Each cycle of treatment is separated by a 2-week treatment-free interval.
Vsakemu ciklusu zdravljenja sledi dvotedenski premor brez zdravljenja.
Blincyto therefore acts as a ‘bridge' bringing T cells and B cells together and causing the T cells to release substances that eventually kill the cancerous B cells.
Zdravilo Blincyto torej deluje kot most, ki povezuje celice T in celice B ter povzroči, da celice T sproščajo snovi, ki sčasoma uničijo rakave celice B.
A study in 70 children aged 1 year and above with Philadelphia-chromosome-negative B-precursor ALL found that in 33% of patients treatment with Blincyto led to a resolution of the disease.
V študiji pri 70 otrocih, starih eno leto in več, z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia so ugotovili, da je pri 33 % bolnikov zdravljenje z zdravilom Blincyto privedlo do odprave bolezni.
Patients were given Blincyto for up to 5 treatment cycles.
Bolniki so prejeli do pet ciklusov zdravljenja z zdravilom Blincyto.
Blincyto is also used in adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body).
Zdravilo Blincyto se uporablja tudi pri odraslih, ki so se zdravili zaradi akutne limfoblastne levkemije predhodniških celic B in imajo minimalno rezidualno bolezen (kar pomeni, da imajo v svojem telesu še vedno nekaj zaznanih rakavih celic).
Blincyto must not be given to breastfeeding women.
Zdravilo Blincyto se ne sme dajati doječim materam.
The Agency noted that Blincyto is beneficial for high-risk adults and children with Philadelphia-chromosome-negative B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Menila je, da je zdravilo Blincyto koristno za odrasle bolnike in otroke z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia, pri katerih obstaja veliko tveganje in ki imajo omejene terapevtske možnosti ter na splošno slabo prognozo.
Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory).
Zdravilo Blincyto se uporablja za zdravljenje krvnega raka, imenovanega akutna limfoblastna levkemija (ALL) predhodniških celic B, pri bolnikih, starejših od enega leta, pri katerih se je rak ponovil (recidiviral) ali se po predhodnem zdravljenju ni izboljšal (neodziven).
For treatment of relapsed or refractory B-precursor ALL, the dose depends on the patient's bodyweight.
Pri zdravljenju ponovljene ali neodzivne akutne limfoblastne levkemije predhodniških celic B je odmerek odvisen od bolnikove telesne mase.
How is Blincyto used?
Kako se zdravilo Blincyto uporablja?
Blincyto is also effective at removing residual cancer cells in adults who have been treated for B-precursor ALL and who are at high risk of the cancer coming back.
Zdravilo Blincyto tudi učinkovito odstranjuje rezidualne rakave celice pri odraslih, ki so se zdravili zaradi akutne limfoblastne levkemije predhodniških celic B in ki so zelo ogroženi za ponovitev raka.
How does Blincyto work?
Kako zdravilo Blincyto deluje?
Blincyto contains the active substance blinatumomab and is used on its own.
Zdravilo Blincyto vsebuje učinkovino blinatumomab in se uporablja kot samostojno zdravilo.
For the full list of side effects of Blincyto, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Blincyto, glejte navodilo za uporabo.
Blincyto is given by infusion (drip) into a vein using a pump device.
Zdravilo Blincyto se daje z infundiranjem (kapalno infuzijo) v veno s črpalko.
Blincyto has been studied in one main study in 189 Philadelphia-chromosome-negative adults with Bprecursor ALL whose leukaemia had come back or had not improved with treatment.
Zdravilo Blincyto so proučevali v eni glavni študiji, v katero je bilo vključenih 189 odraslih z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia, pri katerih se je levkemija ponovila ali katerih stanje se z zdravljenjem ni izboljšalo.
Iceland Lyfis ehf.
Islandija Lyfis ehf.
Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Priloga IA: Zdravila, priporočena za ohranitev, in vloge za pridobitev dovoljenja za promet z zdravilom, za katera je bila ugotovljena bioekvivalenca z referenčnim zdravilom v EU
Annex I List of nationally authorised medicinal products and marketing authorisation applications
Priloga I Seznam nacionalno odobrenih zdravil in vlog za pridobitev dovoljenja za promet z zdravilom
Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Priloga IB: Zdravila, za katere se priporoča začasni umik dovoljenja za promet z zdravilom, in vloge za pridobitev dovoljenja za promet z zdravilom, ki ne ustrezajo merilom za pridobitev dovoljenja
Germany Hexal Aktiengesellschaft
Hexal Aktiengesellschaft
Malacomp HEXAL junior atovaquone/ proguanil
Malacomp HEXAL junior atovakon/ progvanil
25 mg Capsule, hard Oral use
25 mg Kapsula, trda Peroralna uporaba
Saquinavir Sandoz saquinavir
SAQUINAVIR SANDOZ sakvinavir
SAQUINAVIR SANDOZ saquinavir
Saquinavir Sandoz sakvinavir
20 mg Capsule, hard Oral use
20 mg Kapsula, trda Peroralna uporaba
60 mg Capsule, hard Oral use
60 mg Kapsula, trda Peroralna uporaba
100 mg Capsule, hard Oral use
100 mg Kapsula, trda Peroralna uporaba
30 mg Capsule, hard Oral use
30 mg Kapsula, trda Peroralna uporaba
40 mg Capsule, hard Oral use
40 mg Kapsula, trda Peroralna uporaba
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for all authorised methadone medicinal products for oral use containing povidone
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Martindale Pharmaceuticals Ltd. Bampton Road Harold Hill
Velika Britanija Martindale Pharmaceuticals Ltd. Bampton Road
Avda.
S.C.
Procedure Management and Business Support
imetnikov dovoljenja za promet z zdravilom v državah članicah
on 24 July 2009.
dne 24 julija 2009.
Ref.: EMEA/356093/2009 EMEA/H/C/1031
: EMEA/484284/2009 EMEA/H/C/1031
Treatment may continue until the disease gets worse.
Zdravljenje lahko nadaljujemo, dokler se stanje bolezni ne poslabša.
This is repeated every 21 days for six courses or until the disease gets worse.
To ponovimo na vsakih 21 dni in vsega skupaj šest krat ali dokler se stanje bolezni ne poslabša.
Infusions should be carried out in a specialised cancer ward.
Infuzije je treba izvajati na specializiranem oddelku za zdravljenje raka.
Topotecan Actavis topotecan EPAR summary for the public
Topotecan Actavis topotekan Povzetek EPAR za javnost
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Actavis has been shown to be comparable to Hycamtin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Topotecan Actavis primerljivo z zdravilom Hycamtin.
This means that Topotecan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
To pomeni, da je zdravilo Topotecan Actavis podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Hycamtin.
Treatment with Topotecan Actavis should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Zdravljenje z zdravilom Topotecan Actavis lahko poteka samo pod nadzorom zdravnika, izkušenega v uporabi kemoterapije.
It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Zdravilo se uporablja tudi skupaj z zdravilom cisplatin (drugim zdravilom proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v naprednem stadiju (stadij IVB: rak se je že razširil izven materničnega vratu).
The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels.
Pred zdravljenjem je treba preveriti ravni belih krvnih celic, trombocitov in hemoglobina bolnika, da bi se prepričali, ali so te večje od najnižjih določenih ravni.
This prevents the cancer cells from dividing and they eventually die.
To preprečuje delitev rakavih celic in pripelje do njihovega postopnega odmrtja.
Other information about Topotecan Actavis:
Druge informacije o zdravilu Topotecan Actavis:
The Committee recommended that Topotecan Actavis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Topotecan Actavis odobri dovoljenje za promet.
For lung cancer, Topotecan Actavis is given every day for five days with a three-week interval between the start of each course.
Pri pljučnem raku se zdravilo Topotecan Actavis daje vsak dan v trajanju pet dni, čemur sledi tritedenski premor pred pričetkom novega ciklusa zdravljenja.
Because Topotecan Actavis is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Topotecan Actavis generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The dose of Topotecan Actavis to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Odmerek zdravila Topotecan Actavis je odvisen od vrste raka, ki ga zdravimo, in bolnikove telesne mase in višine.
When the enzyme is blocked, the DNA strands break.
S tem ko zaustavimo delovanje encima, začnejo verige DNK razpadati.
What are the benefit and risk of Topotecan Actavis?
Kakšne so koristi in tveganja, povezana z zdravilom Topotecan Actavis?
It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Zdravilo zavira encim, imenovan topoizomeraza I, ki sodeluje v procesu delitve DNK.
Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Hycamtin, odtehtajo znana tveganja.
Because Topotecan Actavis is a generic medicine, the company has provided data from the published literature on topotecan.
Ker je zdravilo Topotecan Actavis generično zdravilo, je družba predložila podatke iz objavljene literature o učinkovini topotekan.
Topotecan Actavis also affects non-cancer cells, which causes side effects.
Zdravilo Topotecan Actavis vpliva tudi na nerakave celice, kar povzroča neželene učinke.
When used with cisplatin in cervical cancer, Topotecan Actavis is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Kadar zdravilo Topotecan Actavis uporabljamo skupaj s cisplatinom za zdravljenje raka materničnega vratu, ga dajemo v obliki infuzije na 1., 2. in 3. dan ciklusa (cisplatin damo na 1. dan).
The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Actavis to Actavis Group PTC ehf.
Evropska komisija je dovoljenje za promet z zdravilom Topotecan Actavis, veljavno po vsej Evropski uniji, odobrila družbi Actavis Group PTC ehf.
It is used on its own to treat patients with small cell lung cancer, when the cancer has relapsed (come back).
Uporablja se samostojno za zdravljenje bolnikov z drobnoceličnim rakom pljuč, pri katerih se rakavo obolenje ponovi.
Topotecan Actavis is a ‘generic medicine'.
Zdravilo Topotecan Actavis je „generično zdravilo“.
The active substance in Topotecan Actavis, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Zdravilna učinkovina v zdravilu Topotecan Activis, topotekan, je zdravilo proti raku, ki spada v skupino zaviralcev topoizomeraze.
Topotecan Actavis is an anticancer medicine.
Topotecan Actavis je zdravilo proti raku.
Topotecan Actavis is a powder to be made up into a solution for infusion (drip into a vein).
Zdravilo Topotecan Actavis je prašek za pripravo raztopine za infundiranje (kapalno infuzijo v veno).
Why has Topotecan Actavis been approved?
Zakaj je bilo zdravilo Topotecan Acatvis odobreno?
The full EPAR for Topotecan Actavis can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Topotecan Actavis je na voljo tukaj.
The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
Če je raven belih krvnih celic še posebej nizka, moramo odmerke prilagoditi ali bolniku začeti dajati druga zdravila.
No additional studies were needed as Topotecan Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Ker je zdravilo Topotecan Actavis generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
What is Topotecan Actavis?
Kaj je zdravilo Topotecan Actavis?
What is Topotecan Actavis used for?
Za kaj se zdravilo Topotecan Actavis uporablja?
How is Topotecan Actavis used?
Kako se zdravilo Topotecan Actavis uporablja?
How has Topotecan Actavis been studied?
Kako je bilo zdravilo Topotecan Acatvis raziskano?
How does Topotecan Actavis work?
Kako zdravilo Topotecan Activis deluje?
It is usually confined to a single limb.
Običajno je omejen na eno okončino.
The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States on 12/01/2016.
Končna faza postopka pregleda je bilo sprejetje pravno zavezujoče odločbe s strani Evropske komisije, ki stopi v veljavo v vseh državah članicah EU dne 12/01/2016.