natgillin/translations-raw huggingface dataset:
It is unknown whether florbetaben (18F) is excreted in human milk.
Ni znano, ali se [18F]florbetaben med dojenjem izloča v materino mleko.
In AD subjects, as in controls, there is high retention in pons and other white matter areas.
Pri preiskovancih z AB in pri kontrolah je zadrževanje v ponsu in drugih predelih bele možganovine veliko.
An overdose is unlikely since you will only receive a single dose of Neuraceq precisely controlled by the nuclear medicine doctor supervising the procedure.
Ker boste prejeli samo en odmerek zdravila Neuraceq pod strogim nadzorom zdravnika nuklearne medicine, ki nadzira postopek, ni verjetno, da bi dobili prevelik odmerek.
The in vivo binding of florbetaben (18F) to other amyloid structures or other brain structures or receptors remains unknown.
Vezava [18F]florbetabena na druge amiloidne strukture ali druge možganske strukture ali receptorje in vivo še ni znana.
This medicinal product contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 mL beer or 12.5 mL wine per dose.
To zdravilo vsebuje 15 vol % etanola (alkohola), to je do 1,2 g na odmerek, kar ustreza 30 ml piva oziroma 12,5 ml vina na odmerek.
BV Cyclotron VU De Boelelaan 1081
BV Cyclotron VU De Boelelaan 1081 1081 HV Amsterdam Nizozemska
Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment has not been characterised.
Ledvična/jetrna okvara Farmakokinetika pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
Smaller area(s) of tracer uptake equal to or higher than that present in white matter: extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within the respective region.
Manjši predel(-i) privzema označevalca, ki je enak kot ali večji od tistega, ki je prisoten v beli možganovini; razširja se čez rob bele možganovine do zunanje kortikalne meje in zajema večino režnjev znotraj zadevne regije.
Mechanism of action Florbetaben (18F) binds to β-amyloid neuritic plaques in the brain.
Mehanizem delovanja [18F]florbetaben se veže na β-amiloidne nevritične lehe v možganih.
Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Rekonstrukcija mora vključevati popravek zaradi atenuacije z nastalo velikostjo transaksialnih slikovnih pik med
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq at the date and time of calibration (ToC).
Ena večodmerna viala vsebuje 1 do 10 ml raztopine, kar ustreza 300 do 3000 MBq ob datumu in času kalibracije (ToC).
The table below shows the dosimetry as calculated using the OLINDA (Organ Level INternal Dose Assessment) software.
OLINDA (Organ Level INternal Dose Assessment).
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, central nervous system;
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: radiodiagnostiki za ugotavljanje bolezni osrednjega živčevja,
Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Pri ocenjevanju gostote β-amiloidnih nevritičnih leh v možganih so opazili napake pri interpretaciji slik, vključno z lažnimi negativnimi in lažnimi pozitivnimi rezultati.
This medicinal product contains up to 33 mg sodium per dose, equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 33 mg natrija na odmerek, kar je enako 1,6% največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections.
Askorbinska kislina, brezvodni etanol, makrogol 400, natrijev askorbat, voda za injekcije.
<Not applicable>
< Navedba smiselno ni potrebna.>
2 (Moderate tracer uptake)
2 (zmeren privzem označevalca)
- Do not use after the expiry date which is stated on the box, shield label and vial label after
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli,
It is hypothesised that unspecific binding of the radiopharmaceutical to the lipid-containing myelin sheath may contribute to white matter retention.
Obstaja hipoteza, da k zadrževanju v beli možganovini morda prispeva nespecifična vezava radiofarmaka na mielinsko ovojnico, ki vsebuje lipide.
Express breast milk during this period and discard the breast milk you have expressed.
V tem času je treba mleko iztisniti in ga zavreči.
The results were lower than the results obtained in the pivotal trial: a sensitivity range between 77.5% to 90% and specificity range between 62.5-85.7%.
dobljeni v ključni študiji: razpon občutljivosti med 77,5 % in 90 % ter razpon specifičnosti
Neuraceq contains the active substance florbetaben (18F).
Zdravilo Neuraceq vsebuje učinkovino [18F]florbetaben.
Avoid any close contact with young children and pregnant women for 24 hours following the injection.
24 ur po injekciji se izogibajte bližnjim stikom z majhnimi otroki in nosečnicami.
Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Za ponovno uvajanje dojena se morate dogovoriti z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
Neuraceq 300 MBq/mL solution for injection florbetaben (18F)
Neuraceq 300 MBq/ml raztopina za injiciranje [18F]florbetaben
The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
10 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje, s čimer se zagotovi injiciranje celotnega odmerka.
The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Zasnova te študije ne omogoča ocene tveganja za napredovanje blage kognitivne okvare v klinično AB. Pediatrična populacija
injection site haematoma (a bruise, a black and blue mark at injection site), injection site warmth, tiredness, feeling hot, pyrexia (raised body temperature, a fever) - Abnormal blood test: increased blood creatinine levels (reduced kidney function)
- stanja na mestu injiciranja: draženje na mestu injiciranja, bolečina in neprijeten občutek okrog mesta injiciranja, hematom na mestu injiciranja (modrica, črna in modra lisa na mestu injiciranja), občutek toplote na mestu injiciranja, utrujenost, občutek vročine, pireksija (povišana telesna temperatura, vročina);
Pharmacodynamic effects At the low chemical concentrations present in Neuraceq, florbetaben (18F) does not have any detectable pharmacodynamic activity.
Ker je [18F]florbetaben v zdravilu Neuraceq prisoten v nizki kemijski koncentraciji, nima zaznavne farmakodinamične aktivnosti.
Upper large intestine Heart
Zgornje debelo črevo
Lower large intestine
Spodnje debelo črevo Tanko črevo
The reason for this accumulation is unknown, but maybe due to accumulation of florbetaben (18F) or to any of its radioactive metabolites, or to blood radioactivity.
Razlog tega privzema ni znan, morda pa je posledica kopičenja [18F]florbetabena,
3 (Pronounced tracer uptake)
3 (izrazit privzem označevalca)
2 Scan with moderate beta-amyloid deposition
2 Rezultat preiskave z zmernim ß-amiloidnim odlaganjem
Neuraceq 300 MBq/mL solution for injection
Neuraceq 300 MBq/ml raztopina za injiciranje
After administration of Neuraceq, you should:
Po prejemu zdravila Neuraceq morate:
A PET scan with florbetaben (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders.
4.2 Odmerjanje in način uporabe PET-preiskavo s [18F]florbetabenom mora naročiti zdravnik, usposobljen za klinično obravnavo nevrodegenerativnih bolezni.
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq of florbetaben (18F) at the date and time of calibration.
Ena večodmerna viala vsebuje 1 do 10 ml raztopine, kar ustreza 300 do 3000 MBq [18F]florbetabena ob datumu in času kalibraije.
Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate (for pH adjustment), water for injections
Askorbinska kislina, brezvodni etanol, makrogol 400, natrijev askorbat (za uravnavanje pH), voda za injekcije.
How Neuraceq will be used
Kako uporabljati zdravilo Neuraceq
Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration.
1 ml raztopine za injiciranje vsebuje 300 MBq [18F]florbetabena na dan in ob času kalibracije.
The activity per vial ranges from 300 MBq to 3000 MBq at the date and time of calibration.
Delovanje na vialo je v območju od 300 MBq do 3000 MBq na datum in uro kalibracije.
What Neuraceq looks like and contents of the pack
Izgled zdravila Neuraceq in vsebina pakiranja
In radioligand binding assays using a broad panel of animal and human receptors, ion channels and transporters no significant binding was found.
Pri študijah vezave radioligandov ob uporabi širokega spektra animalnih in humanih receptorjev,
Uptake has also been identified in some cases in extracerebral structures such as face, scalp and bone.
V nekaterih primerih so opazili privzem tudi v zunajmožganskih strukturah, na primer na obrazu,
Pain in extremity Limb discomfort
Bolečine v okončinah Neprijeten občutek v okončinah
1 Scan without beta-amyloid deposition
1 Rezultat preiskave brez ß-amiloidnega odlaganja
The PET results were compared with the maximal neuritic plaque density measured on sections of middle frontal gyrus, superior and middle temporal gyri, inferior parietal lobe, hippocampus and other brain regions at the patient's autopsy.
superiorne in srednje temporalne vijuge, inferiornega parietalnega režnja, hipokampusa in drugih možganskih predelih med obdukcijo bolnika.
Life Radiopharma Bonn GmbH, Germany IBA Molecular Italy S.R.L., Monza, Italy IBA Molecular Italy S.R.L., Rome, Italy IBA Molecular Italy S.R.L., Udine, Italy Curium Pharma Spain, S.A., Seville, Spain Curium Pharma Spain, S.A., Madrid, Spain Seibersdorf Labor GmbH, Austria BetaPlus Pharma SA, Brussels, Belgium Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain
Life Radiopharma Warszawa Sp. z o.o., Poljska Life Radiopharma Bonn GmbH, Nemčija IBA Molecular Italy S.R.L., Monza, Italija IBA Molecular Italy S.R.L., Rome, Italija IBA Molecular Italy S.R.L., Udine, Italija Curium Pharma Spain, S.A., Seville, Španija Curium Pharma Spain, S.A., Madrid, Španija Seibersdorf Labor GmbH, Avstrija
- The active substance is florbetaben (18F).
- Zdravilna učinkovina je [18F]florbetaben.
Alliance Medical Radiopharmacy Ltd., UK BV Cyclotron VU, the Netherlands Cis Bio International, Nancy, France Cis Bio International, Nîmes, France Cis Bio International, Paris, France Cis Bio International, Rennes, France Cis Bio International, Pessac, France Life Radiopharma Berlin GmbH, Germany Advanced Accelerator Applications Germany GmbH, Germany Life RadiopharmaWarszawa Sp. z o.o., Poland
Alliance Medical Radiopharmacy Ltd., VB BV Cyclotron VU, Nizozemska Cis Bio International, Nancy, Francija Cis Bio International, Nîmes, Francija Cis Bio International, Pariz, Francija Cis Bio International, Rennes, Francija Cis Bio International, Pessac, Francija
In completed clinical trials, uptake of florbetaben (18F) in 7 predefined cortical areas of the brain (frontal, parietal, lateral and medial temporal, occipital, caudate, posterior cingulate/precuneus cortex, and anterior cingulate gyrus) and cerebellar cortex was measured quantitatively using standardised uptake values (SUV).
Pri zaključenih kliničnih preskušanjih so privzem [18F]florbetabena na 7 vnaprej opredeljenih kortikalnih možganskih območjih (frontalna, parietalna, lateralna in medialna temporalna, okcipitalna,
For an administered activity of 360 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 49.3 mGy, 25.0 mGy, 13.8 mGy, 12.6 mGy, 11.3 mGy and 13.9 mGy, respectively.
znašajo 49,3 mGy, 25,0 mGy, 13,8 mGy, 12,6 mGy, 11,3 mGy oziroma 13,9 mGy.
In all 31 subjects, a blinded visual subject-level PET reading by 3 blinded readers resulted in a majority read sensitivity of 100% (95% CI: 80.5-100%) and specificity 85.7% (95% CI: 67.4 - 100%).
pri čemer je bila občutljivost večine odčitavanj 100 % (95-odstotni IZ: 80,5-100 %), specifičnost pa 85,7 % (95-odstotni IZ: 67,4-100 %).
If you get any side effects please talk to your nuclear medicine doctor.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine.
3 Scan with pronounced beta-amyloid deposition
3 Rezultat preiskave z izrazitim ß-amiloidnim odlaganjem
If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom nuklearne medicine,
• The training material should include Neuraceq PET demonstration cases with correct PET scan interpretation by an experienced reader Neuraceq-PET scans for self-assessment and a selfqualification procedure to be offered to each trainee.
Neuraceq s pravilno interpretacijo PET-preiskave, ki jo poda izkušen odčitovalec, vsem udeležencem usposabljanja pa se ponudijo PET-preiskave z zdravilom Neuraceq za samoocenjevanje in postopek za samokvalifikacijo.
Vessel puncture site pain Catheter site pain Injection site haematoma Injection site irritation Puncture site reaction Injection site discomfort Injection site warmth
Hematom na mestu injiciranja Draženje na mestu injiciranja Reakcija na mestu vboda
Table 3: List of adverse reactions System Organ Class
Tabela 3: Seznam neželenih učinkov
Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F).
Slike z zdravilom Neuraceq smejo interpretirati le odčitovalci, usposobljeni za interpretacijo PET
No animal studies have been conducted to investigate the reproductive effects in florbetaben (18F) (see section 5.3).
[18F]florbetabena na razmnoževanje, niso izvedli (glejte poglavje 5.3).
Renal impairment and hepatic impairment
Ledvična in jetrna okvara
The effective dose resulting from the administration of a maximal recommended activity of 360 MBq dose for an adult weighing 70 kg is about 7.0 mSv.
Učinkoviti odmerek (mSv/MBq) 0,0193 Učinkoviti odmerek po dajanju največjega priporočenega odmerka 360 MBq pri odraslem, ki tehta
Contents of the pack and other information
Shranjevanje zdravila Neuraceq Vsebina pakiranja in dodatne informacije
Limitations of use
POSTOPEK UPORABE
The potential toxicity of 28 days of repeated intravenous injections of florbetaben (18F) was tested in rats and dogs, and the NOAEL was found to be at least 20 times the maximum human dose.
Na podganah in psih so preskušali morebitno toksičnost z 28-dnevnim ponavljajočim se intravenskim injiciranjem
In vivo, quantitative correlation was not assessed in end-of-life patients between florbetaben (18F)
In vivo pri bolnikih ob koncu življenja niso ocenjevali kvantitativne povezave med privzemom [18F]florbetabena v kortikalni sivi možganovini in β-amiloidnimi oblogami pri obdukcijskih vzorcih.
Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view.
Bolniki morajo ležati na hrbtu, glava pa mora biti v položaju, v katerem so možgani, vključno z malimi možgani, v vidnem polju aparata za PET. Za zmanjševanje premikanja glave lahko uporabite trak ali drug fleksibilen pripomoček za omejevanje premikanja glave.
Alliance Medical Radiopharmacy Ltd., UK BV Cyclotron VU, the Netherlands Cis Bio International, Nancy, France Cis Bio International, Nîmes, France Cis Bio International, Paris, France Cis Bio International, Rennes, France Cis Bio International, Pessac, France Life Radiopharma Berlin GmbH, Germany Advanced Accelerator Applications Germany GmbH, Germany Life Radiopharma Warszawa Sp. z o.o., Poland Life Radiopharma Bonn GmbH, Germany IBA Molecular Italy S.R.L., Monza, Italy IBA Molecular Italy S.R.L., Rome, Italy IBA Molecular Italy S.R.L., Udine, Italy Curium Pharma Spain, S.A., Seville, Spain Curium Pharma Spain, S.A., Madrid, Spain Seibersdorf Labor GmbH, Austria BetaPlus Pharma SA, Brussels, Belgium Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain
Advanced Accelerator Applications Germany GmbH, Nemčija Life Radiopharma Warszawa Sp. z o.o., Poljska Life Radiopharma Bonn GmbH, Nemčija IBA Molecular Italy S.R.L., Monza, Italija IBA Molecular Italy S.R.L., Rome, Italija IBA Molecular Italy S.R.L., Udine, Italija Curium Pharma Spain, S.A., Seville, Španija Curium Pharma Spain, S.A., Madrid, Španija Seibersdorf Labor GmbH, Avstrija
In a post-hoc analysis sensitivity and specificity of the majority read of the visual subject-level PET reading vs histopathology in a larger population (74 patients) was 97.9% (95% CI: 93.8 - 100%) and 88.9% (95% CI: 77-100%).
97,9 % (95-odstotni IZ: 93,8-100 %) in 88,9 % (95-odstotni IZ: 77-100 %).
Package leaflet: Information for the patient Neuraceq 300 MBq/mL solution for injection florbetaben (18F)
Neuraceq 300 MBq/ml raztopina za injiciranje [18F]florbetaben intravenska uporaba
Toxic skin eruption Rash
Toksični kožni izpuščaj Izpuščaj
In addition, binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated by autoradiography and supported by immunohistochemistry or Bielschowsky stain.
Poleg tega je bila vezava [18F]florbetabena na β-amiloidne lehe v predelih možganov z AB
application site erythema)
(eritem na mestu injiciranja/aplikacije);
- Keep this leaflet.
- dojite.
Uterus
Žolčnik
Positive scan
Pozitivni rezultati preiskave
How Neuraceq is stored
Shranjevanje zdravila Neuraceq
Neuralgia Headache Burning sensation Tremor
Občutek vročine Bolečina na mestu vboda v žilo Bolečina na mestu katetra
Ovaries
Odmerek
Bladder
Vranica
Adrenal
Hematom
Customer ref
Ref.
Intravenous use.
intravenska uporaba večodmerno
METHOD OF ADMINISTRATION
Način priprave
Pyrexia
Pireksija Utrujenost
Small intestine
Možgani Dojke
That information was already present in the majority member states, and was in general acceptable.
• Te informacije so v večini držav članic že bile predstavljene in so bile v veliki meri sprejemljive.
In addition minor typographic errors were corrected.
Popravljene so bili tudi manjše tipografske napake.
Flolan is authorised in the following member states: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, The Netherlands, Spain and United Kingdom and in Norway.
• Zdravilo Flolan ima dovoljenje za promet v naslednjih državah članicah: Avstriji, Belgiji, Češki republiki, Danski, Estoniji, Franciji, Irski, Italiji, Luksemburgu, Malti, Nizozemski, Španiji in Združenem kraljestvu ter Norveški.
In some cases these differences are due to the differences in indications.
V nekaterih primerih so bile razlike posledica razlik v indikacijah.
Quality - Module 3
Kakovost - Modul 3
The use of Flolan in children and elderly is not harmonised.
Uporaba zdravila Flolan pri otrocih in starejših ni usklajena.
• The committee considered the referral under Article 30 of Directive 2001/83/EC
• Odbor je obravnaval napotitev na podlagi člena 30 Direktive 2001/83/ES.
This section is one of the identified for harmonisation.
To poglavje je eno izmed določenih poglavij za uskladitev.
It also agreed on the recommended schedule of infusion in adults.
Dogovorjen je bil tudi priporočen režim infundiranja pri odraslih.
Labelling
• Označevanje
Information on development, manufacture and control of powder and solvent for solution for infusion has been presented in a satisfactory manner.
Informacije o razvoju, izdelavi in nadzoru praška in vehikla za raztopino za infundiranje so bile predstavljene na zadovoljiv način.
Based on the review of data the CHMP adopted a harmonised Module 3.
Na podlagi pregleda podatkov je CHMP sprejel usklajen modul 3.
However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Vendar pa je bilo 9 od 27 dializ z epoprostenolom po več poskusih neuspešnih.
All these changes were accepted by the CHMP.
CHMP je vse spremembe sprejel.
The proposal for changes in section 4.8 was mainly based on the Core Safety Profile (CSP) which has been agreed in 2009 during the PSUR Worksharing Procedure (IE/H/PSUR/0018/001).
• Predlagane spremembe v poglavju 4.8 temeljijo pretežno na temeljnem varnostnem profilu zdravila (CSP - Core Safety Profile), ki je bil dogovorjen leta 2009 v postopku delitve dela PSUR (IE/H/PSUR/0018/001).
Section 4.4 - Special warnings and precaution for use There are differences in the special warnings and precautions for use included in Section 4.4, and in the detail given with respect to these warnings/precautions.
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Obstajajo razlike med posebnimi opozorili in previdnostnimi ukrepi v poglavju 4.4 in v podrobnostih, navedenih za ta posebna opozorila in previdnostne ukrepe.
Improvements were apparent in some patients at the end of the first week of therapy.
Pri nekaterih bolnikih se je izboljšanje pokazalo ob koncu prvega tedna zdravljenja.
Also the CHMP agreed that given the absence of alternative medicines, epoprostenol can be used in those women who choose to continue their pregnancy, despite the known risk of pulmonary arterial hypertension during pregnancy.
CHMP se je strinjal tudi, da se lahko epoprostenol zaradi odsotnosti nadomestnih zdravil uporablja pri ženskah, ki se odločijo nosečnost ohraniti, kljub znanemu tveganju za pljučno arterijsko hipertenzijo med nosečnostjo.
Improvements were apparent as early as the first week of therapy.
Izboljšanja so bila opazna že prvi teden zdravljenja.
There was no clear consistent evidence that patients receiving either treatment improved more often or worsened less often.
Jasnih trdnih dokazov, da se je stanje pri bolnikih v eni od skupin zdravljenja pogosteje izboljšalo ali manj pogosto poslabšalo, ni bilo.
The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Rezultati opravljenih testov kažejo na zadovoljivo doslednost in poenotenost pomembnih značilnosti glede kakovosti zdravila, kar posledično vodi do zaključka, da bi moralo zdravilo v klinični praksi delovati zadovoljivo in enakomerno.
The labelling has been updated according to the latest QRD v8 template.
• Označevanje je bilo posodobljeno v skladu z najnovejšo predlogo za pregled kakovosti dokumentov (QRD) v8.
Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Večina dializ z epoprostenolom (67 %), pri katerih je bilo treba umetno ledvico zamenjati, se je nato zaključila z epoprostenolom brez koagulacije.
Mean systemic arterial pressure was not significantly different between the two groups (-4.33 vs. -3.05 mm Hg).
Srednji sistemski arterijski tlak se med skupinama ni značilno razlikoval (-4,33 v primerjavi z -3,05 mm Hg).
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified on 15 June 2011 the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SmPCs and thus to harmonise its divergent SmPCs labelling and package leaflet across the European Union.
Zaradi razhajajočih se nacionalnih odločitev držav članic o odobritvi dovoljenj za promet z zgoraj navedenimi zdravili (in povezanimi imeni) je Evropska komisija dne 15. junija 2011 obvestila tajništvo odbora CHMP pri agenciji EMA o uradni napotitvi v skladu s členom 30 Direktive 2001/ 83/ ES za razrešitev nesoglasij med nacionalnimi povzetki glavnih značilnosti zdravila in s tem uskladitev različnih povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo v vsej Evropski uniji.