FrancophonIA/ELRC3.0 huggingface dataset:
English: Two Concerned Member States (the Netherlands and Sweden) considered that the authorisation of Clavudale 50 mg in cats may present a potential serious risk to animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Slovenian: Dve zadevni državi članici (Nizozemska in Švedska) sta menili, da bi lahko odobritev zdravila Clavudale 50 mg pri mačkah predstavljala morebitno resno tveganje za zdravje živali, saj varnost in učinkovitost zdravila nista bili ustrezno dokazani.
English: For a minority of cases (refractory cases), a dose rate of 25 mg/kg twice daily for up to 28 days is proposed.
Slovenian: V manjšem številu primerov (neodzivni primeri) je predlagan odmerek 25 mg/kg dvakrat na dan do 28 dni.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti veterinarskega zdravila, živalskih vrst, poti uporabe, predlagateljev/imetnikov dovoljenja za promet z zdravilom v državah članicah
English: The failure to demonstrate bioequivalence may well have been influenced by the study design (lack of power) rather than by true non-bioequivalence of the generic and reference products.
Slovenian: Neuspešnost pri dokazovanju biološke enakovrednosti je tako lahko posledica načrta študije (nezadostna moč) in ne resnične biološke neenakovrednosti generičnega in referenčnega zdravila.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku usklajevalne skupine.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Clavudale 50 mg.
Slovenian: CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Clavudale 50 mg.
English: • accepted demonstration of bioequivalence within the 0.8-1.25 acceptance limits in dogs with a different tablet strength;
Slovenian: • dokazane biološke enakovrednosti v intervalu meja sprejemljivosti 0,8-1,25 pri psih z različnimi jakostmi tablet;
English: Given the above, as well as current efforts to reduce the number of animals taking part in studies, it was considered unnecessary and unjustifiable to request the applicant to conduct another, larger, study in cats.
Slovenian: Glede na navedeno in trenutna prizadevanja za zmanjšanje števila živali, ki sodelujejo v študijah, se je zahteva, da predlagatelj izvede še eno, večjo študijo pri mačkah, štela kot nepotrebna in neupravičena.
English: When data from one particular cat, considered an outlier by the applicant, were excluded from the analysis, the 90% confidence internal fell within the acceptance limits.
Slovenian: Ko so bili podatki, ki so bili pridobljeni pri določeni mački in za katere je predlagatelj menil, da odstopajo, izključeni iz analize, je 90-odstotni interval zaupanja padel znotraj meja sprejemljivosti.
English: The guideline on the conduct on bioequivalence studies indicates that bioequivalence (based on in vivo data) should always be established based on conclusive studies in each major animals species for which an indication is claimed.
Slovenian: Smernica o izvajanju študij biološke enakovrednosti navaja, da je treba biološko enakovrednost (na podlagi podatkov in vivo) vedno dokazati na podlagi prepričljivih študij pri vseh pomembnejših živalskih vrstah za vse predložene indikacije.
English: It was shown that, in dogs, the commonly used excipients present in the generic formulation did not affect the rate or extent of absorption of amoxicillin.
Slovenian: Dokazano je bilo, da pri psih pogosto rabljene pomožne snovi, ki so bile uporabljene v generični formulaciji, niso vplivale na hitrost ali obseg absorpcije amoksicilina.
English: The dissolution studies presented by the applicant demonstrated similar dissolution profiles when different strengths of the generic and reference products were compared, which provides further reassurance on the pharmaceutical quality of the tablets.
Slovenian: Študije raztapljanja, ki jih je predložil predlagatelj, so pokazale podoben profil raztapljanja pri primerjavi različnih jakosti generičnega in referenčnega zdravila, kar še dodatno potrjuje farmacevtsko kakovost tablet.
English: Bioequivalence is claimed with the reference product, Synulox Palatable Tablets 50 mg, marketed by Pfizer Ltd and authorised in the United Kingdom since 20/08/1990.
Slovenian: Zagotovljeno je, da je zdravilo biološko enakovredno referenčnemu zdravilu Synulox Palatable Tablets 50 mg, ki ga trži družba Pfizer Ltd in je v Združenem kraljestvu odobreno od 20. avgusta 1990.
English: However, in the case of the amoxicillin, the lower limit of the 90% confidence interval for the ratio of geometric means for maximum plasma concentration (Cmax) and area under the plasma concentration/time curve (AUC) fell just below the acceptance limit.
Slovenian: Vendar pa je bila v primeru amoksicilina spodnja meja 90-odstotnega intervala zaupanja za kvociente geometričnih povprečij za največjo koncentracijo v plazmi (Cmax) in območje pod krivuljo koncentracija v plazmi/čas (AUC) nekoliko pod mejo sprejemljivosti.
English: In addition, a comparative in vitro dissolution study was conducted between the generic and reference products.
Slovenian: Izvedena je bila tudi primerjalna študija raztapljanja in vitro med generičnim in referenčnim zdravilom.
English: Clavudale 50 mg tablets contain amoxicillin and clavulanic acid in a ratio of 4:1, thus the 50 mg tablet contains 40 mg amoxicillin/10 mg clavulanic acid.
Slovenian: Tablete zdravila Clavudale 50 mg vsebujejo amoksicilin in klavulansko kislino v razmerju 4 : 1, kar pomeni, da 50-miligramskatableta vsebuje 40 mg amoksicilina in 10 mg klavulanske kisline.
English: This referral under Article 33(4) of Directive 2001/82/EC was made on the basis that the applicant had not satisfactorily demonstrated bioequivalence between the generic product, Clavudale 50 mg tablet for cats and dogs, and the reference product, Synulox Palatable Tablets 50 mg, in the cat target species.
Slovenian: Napotitev v skladu s členom 33(4) Direktive 2001/82/ES je bila sprožena na osnovi dejstva, da predlagatelj ni ustrezno dokazal biološke enakovrednosti med generičnim zdravilom Clavudale 50 mg tablet for cats and dogs in referenčnim zdravilom Synulox Palatable Tablets 50 mg pri ciljni živalski vrsti mačk.
English: The applicant had conducted a two-period crossover in vivo bioequivalence study in cats.
Slovenian: Predlagatelj je pri mačkah izvedel navzkrižno študijo in vivo biološke enakovrednosti v dveh obdobjih.
English: Given,
Slovenian: Ob upoštevanju:
English: In the in vivo bioequivalence study conducted in cats, the 90% confidence interval for the ratio of geometric means of the pivotal pharmacokinetic parameters for demonstrating bioequivalence fell within pre-defined acceptance limits of 0.8 to 1.25 for clavulanic acid.
Slovenian: Pri študiji biološke enakovrednosti in vivo, ki je bila izvedena pri mačkah, je bil 90-odstotni interval zaupanja kvocientov geometrijskih povprečij ključnih farmakokinetičnih parametrov za dokazovanje biološke enakovrednosti v predhodno opredeljenih mejah sprejemljivosti med 0,8 do 1,25 za klavulansko kislino.
English: Scientific conclusions for granting of the marketing authorisation
Slovenian: Znanstveni zaključki za odobritev dovoljenja za promet z zdravilom
English: It was considered that, given the similar variability that was seen between the cat study and the larger dog bioequivalence study, the smaller size of the cat study may have made it more vulnerable to the effects of one cat with an anomalous pharmacokinetic profile.
Slovenian: Glede na to da je bila med študijo pri mačkah in večjo študijo biološke enakovrednosti pri psih opažena podobna variabilnost, se je štelo, da je študija pri mačkah zaradi manjšega obsega bolj občutljiva za učinke pri eni mački z neobičajnim farmakokinetičnim profilom.
English: Notwithstanding, the bioequivalence study in dogs provides reassurance that the formulation of the product is unlikely to be a contributing factor impacting on bioavailability in cats given that the 50 mg and 250 mg tablets are directly proportional and bioequivalence was satisfactorily demonstrated in dogs for both active substances.
Slovenian: Vendar pa študija biološke enakovrednosti pri psih zagotavlja, da formulacija zdravila verjetno ne vpliva na biološko razpoložljivost pri mačkah, glede na to, da so 50-miligramske in 250-miligramske tablete neposredno sorazmerne in je bila pri psih biološka enakovrednost ustrezno dokazana za obe zdravilni učinkovini.
English: Overall summary of the scientific evaluation of Clavudale 50 mg tablet for cats and dogs and associated names (see Annex I), hereinafter referred to as Clavudale 50 mg
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Clavudale 50 mg tablet for cats and dogs in povezanih imen (glejte Dodatek I), v nadaljevanju „zdravilo Clavudale 50 mg“
English: Therefore, the CVMP recommends the granting of the marketing authorisations for Clavudale 50 mg tablets for cats and dogs and associated names (see Annex I) for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: Zato CVMP priporoča odobritev dovoljenja za promet z zdravilom Clavudale 50 mg tablet for cats and dogs in povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: Having considered all of the data submitted in writing, the CVMP concludes that there is no rigorous scientific basis for a conclusion of serious risk in the cat target species based on a lower confidence limit for the AUC of amoxicillin which fell only narrowly below the pre-specified lower limit.
Slovenian: Ob upoštevanju vseh podatkov, predloženih v pisni obliki, je CVMP sklenil, da nižja meja zaupanja za AUC amoksicilina, ki je bila nekoliko pod predhodno določeno spodnjo mejo, ne predstavlja trdne znanstvene podlage za sklepanje o resnem tveganju pri ciljni vrsti mačk.
English: Grounds for recommendation of the granting of marketing authorisations
Slovenian: Podlaga za priporočilo za odobritev dovoljenja za promet z zdravilom
English: Luxembourg Dechra Limited, Sansaw Business
Slovenian: Luksemburg Dechra Limited, Sansaw Business
English: Belgium Dechra Limited, Sansaw Business
Slovenian: Nizozemska Dechra Limited, Sansaw Business
English: • the similar and very rapid dissolution profiles of the generic and reference products at three pHs; the weight of evidence is considered to support that the benefits of this product when used in the cat outweigh the potential risks.
Slovenian: • podobnega in zelo hitrega profila raztapljanja generičnega in referenčnega zdravila pri treh vrednostih pH;
English: The Netherlands
Slovenian: Združeno kraljestvo
English: This summary was last updated in 04-2007.©EMEA 2007
Slovenian: Povzetek je bil nazadnje posodobljen 04-2007.©EMEA 2007
English: The enhancement of imaging starts 15 to 20 minutes after the start of the infusion, and lasts for about 4 hours.
Slovenian: Ojačevanje slike se začne 15 do 20 minut po začetku infundiranja in traja približno 4 ure.
English: This allows the difference between normal and abnormal tissue to
Slovenian: Zaradi tega postane razlika med običajnim in neobičajnim tkivom vidna.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TESLASCAN to GE Healthcare AS on 22 May 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom TESLASCAN, veljavno po vsej Evropski uniji, odobrila družbi GE Healthcare AS dne 22. maja 1997.
English: Overall, during the studies, 33% of patients had more lesions detected after TESLASCAN but 20% of patients had fewer lesions.
Slovenian: Skupaj so med študijami pri 33 % bolnikih po uporabi zdravila TESLASCAN opazili več lezij, 20 % bolnikov pa je imelo v resnici manj lezij.
English: What benefit has TESLASCAN shown during the studies?
Slovenian: Kakšne koristi je zdravilo TESLASCAN izkazalo med raziskavami?
English: As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Slovenian: Posledica tega vpliva je, da molekule vode oddajo močnejši signal, ki pomaga ustvariti jasnejšo sliko.
English: TESLASCAN is used as a single intravenous infusion at a dose of 0.5 ml per kilogram body weight.
Slovenian: Zdravilo TESLASCAN uporabljamo kot enkratno intravensko infuzijo v odmerku, ki znaša 0,5 ml na kilogram telesne mase.
English: The rate of infusion is 2 to 3 ml/min for liver imaging and 4 to 6 ml/min for imaging the pancreas.
Slovenian: Hitrost infundiranja znaša 2 do 3 ml/min pri slikanju jeter in 4 do 6 ml/min pri slikanju trebušne slinavke.
English: TESLASCAN is for diagnostic use.
Slovenian: Zdravilo TESLASCAN je za diagnostične namene.
English: The patients had between one and five liver lesions that had already been detected using MRI, ultrasound, or computerised tomography (CT).
Slovenian: Bolniki so imeli eno do pet lezij, ki so jih predhodno že ugotovili s pomočjo magnetno resonančnega slikanja, ultrazvočnega pregleda ali računalniške tomografije (CT).
English: The studies of TESLASCAN in MRI for liver lesions involved 617 patients.
Slovenian: V študije zdravila TESLASCAN pri magnetno resonančnem slikanju zaradi jetrnih lezij je bilo vključenih 617 bolnikov.
English: Water molecules in the body are affected by the magnetic fields, and produce a signal when the radio waves are applied.
Slovenian: Magnetna polja vplivajo na molekule vode v telesu, ki nato ob uporabi radijskih valov oddajo signal.
English: MRI is an imaging method that uses magnetic fields and radio waves.
Slovenian: Magnetno resonančno slikanje je metoda slikanja, ki izrablja magnetna polja in radijske valove.
English: TESLASCAN is used in patients who are undergoing magnetic resonance imaging (MRI) to detect lesions (damaged tissue) in the liver that might be caused by liver cancer or cancer that has spread to the liver from other parts of the body.
Slovenian: Zdravilo TESLASCAN se uporablja pri bolnikih pred magnetno resonančnim slikanjem (MRI), s pomočjo katerega se ugotavljajo lezije (poškodbe tkiva) v jetrih, ki bi jih utegnil povzročiti jetrni rak ali rak, ki se je razširil iz jeter v druge dele telesa.
English: TESLASCAN should not be used in pregnant or breastfeeding women, patients with phaeochromocytoma (a tumour of the adrenal gland), or patients with severe problems with their liver or kidneys.
Slovenian: Zdravila TESLASCAN se ne sme uporabljati pri nosečnicah ali doječih ženskah, bolnikih s feokromocitomom (tumor nadledvične žleze) ali bolnikih s hudimi težavami z jetri ali ledvicami.
English: The full EPAR for TESLASCAN is available here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo TESLASCAN je na voljo tukaj.
English: The main measure of effectiveness was based on the agreement between the diagnosis made based on the scans, and the actual lesions as seen during surgery or biopsy.
Slovenian: Glavno merilo učinkovitosti je bilo sovpadanje diagnoze na osnovi slikanj in dejanskimi lezijami, ki so jih odkrili med kirurškim posegom ali biopsijo.
English: In TESLASCAN, the manganese is bound to another chemical in a ‘chelate'.
Slovenian: Mangan v zdravilu TESLACAN je vezan z drugo kemično spojino v t.i. „kelat“.
English: The Committee for Medicinal products for Human Use (CHMP) decided that TESLASCAN's benefits are greater than its risks as a contrast medium for diagnostic MRI, for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas, and as an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je mnenja, da so koristi zdravila TESLASCAN večje od z njim povezanih tveganj pri uporabi kot kontrastno sredstvo pri diagnostičnem magnetno resonančnem slikanju za odkrivanje lezij jeter, do katerih naj bi predvidoma prišlo zaradi metastaznega stadija bolezni ali hepatoceličnih karcinomov, in kot dodatka pri magnetno resonančnem slikanju za pomoč pri preiskovanju fokalnih lezij trebušne slinavke.
English: Manganese interacts with the water molecules.
Slovenian: Mangan in vodne molekule vplivajo drug na druge.
English: TESLASCAN is a ‘contrast medium' that is used to obtain a clearer scan.
Slovenian: Zdravilo TESLACAN je „kontrastno sredstvo“, ki se uporablja za jasnejšo vidnost slik.
English: The studies of pancreatic disease involved 292 patients, and compared the effectiveness of TESLASCAN-enhanced MRI with that of ‘spiral CT', another diagnostic method used to detect pancreatic lesions.
Slovenian: V študije bolezni trebušne slinavke je bilo vključenih 292 bolnikov, v njih pa so primerjali učinkovitost magnetno resonančnega slikanja, ojačanega z zdravilom TESLASCAN, ter „spiralne računalniške tomografije (CT)“, ki je še ena diagnostična metoda za odkrivanje lezij trebušne slinavke.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TESLASCAN Povzetek EPAR za javnost
English: Manganese is used as a contrast medium to help obtain better pictures with MRI scanners.
Slovenian: Mangan uporabljamo kot kontrastno sredstvo, ki pri magnetno resonančnem slikanju pomaga ustvariti boljše slike.
English: TESLASCAN should not be used in people who may be hypersensitive (allergic) to mangafodipir trisodium or any of the other ingredients.
Slovenian: Zdravila TESLASCAN ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) trinatrijev mangafodipir ali katero koli drugo sestavino zdravila.
English: The most common side effects with TESLASCAN (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), flushing and feeling hot. For the full list of all side effects reported with TESLASCAN, see the Package Leaflet.
Slovenian: Najpogostejši neželeni učinki pri uporabi zdravila TESLASCAN (opaženi pri od 1 do 10 bolnikov od 100) so glavobol, navzeja (občutek slabosti), rdečica in občutek toplote.
English: For more information, see the Package Leaflet.
Slovenian: Za nadaljnje informacije si oglejte Navodilo za uporabo.
English: The active substance in TESLASCAN, mangafodipir, contains manganese, a metal element.
Slovenian: Mangafodipir, ki je zdravilna učinkovina v zdravilu TESLASCAN, vsebuje mangan, element iz skupine kovin.
English: Once the medicine is injected, the manganese is released and taken up by normal liver and pancreatic tissues more effectively than by the cancer cells.
Slovenian: Ko zdravilo vbrizgamo, se mangan sprosti, tega pa zdrava jetra in zdrava tkiva trebušne slinavke vsrkavajo bolje kot rakaste celice.
English: In the detection of pancreatic lesions, TESLASCAN-enhanced MRI was as effective as spiral CT.
Slovenian: Pri odkrivanju lezij trebušne slinavke je bilo magnetno resonančno slikanje, ojačano z zdravilom TESLASCAN, enako učinkovito kot spiralna računalniška tomografija (CT).
English: TESLASCAN is a solution for infusion (drip into a vein) containing the active substance mangafodipir
Slovenian: Zdravilo TESLASCAN je raztopina za infuzijo (dajanje v veno), ki vsebuje zdravilno učinkovino trinatrijev mangafodipir.
English: What is the risk associated with TESLASCAN?
Slovenian: Kakšna tveganja so povezana z zdravilom GANFORT?
English: The main measure of effectiveness was the difference in the number of liver lesions detected in the previous scan and when using TESLASCAN during MRI.
Slovenian: Glavno merilo učinkovitosti je bila razlika v številu lezij, ki so jih ugotovili s prej omenjenimi načini slikanja in magnetnim resonančnim slikanjem, ojačanim z zdravilom TESLASCAN.
English: The marketing authorisation was renewed
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom TESLASCAN.
English: In the detection of liver lesions, the use of TESLASCAN-enhanced MRI resulted in more lesions being detected.
Slovenian: Magnetno resonančno slikanje, ojačano z zdravilom TESLASCAN, je pri ugotavljanju jetrnih lezij omogočilo ugotoviti več lezij.
English: They underwent a TESLASCAN-enhanced MRI scan.
Slovenian: Vsi so prestali še magnetno resonančno slikanje, ojačano z zdravilom TESLASCAN.
English: TESLASCAN can also be used with MRI to investigate
Slovenian: Zdravilo TESLASCAN se lahko uporablja skupaj z magnetno resonančnim slikanjem tudi pri preiskovanju lezij na trebušni slinavki.
English: DATE OF REVISION OF THE TEXT
Slovenian: - DATUM ZADNJE REVIZIJE BESEDILA
English: - Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Slovenian: - Slabost: če izgubite tek in če je količina hrane, ki jo zaužijete vsak dan mnogo manjša kot ponavadi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013
Slovenian: - DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 21 junij 2013
English: - Take the tablets in the morning and evening as prescribed by your doctor.
Slovenian: - Tablete jemljite zjutraj in zvečer, kot vam je predpisal zdravnik.
English: - It is important that you take all your medicines as prescribed by your doctor.
Slovenian: - Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal vaš zdravnik.
English: Tell your doctor immediately if you experience any of these symptoms.
Slovenian: Takoj obvestite svojega zdravnika, če imate katerega od teh simptomov.
English: - Take the tablets within 30 minutes after the end of a meal (breakfast and dinner).
Slovenian: - Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje).
English: Before starting treatment, you must tell your doctor if you are pregnant, if you think you may be pregnant or if you intend to become pregnant.
Slovenian: Pred začetkom zdravljenja morate svojemu zdravniku povedati, če ste noseči, če mislite, da ste noseči ali če nameravate zanositi.
English: Central or peripheral nervous system disease.
Slovenian: Bolezni centralnega ali perifernega živčnega sistema.
English: Severe skin reactions.
Slovenian: Hude kožne reakcije.
English: keratitis (rare)
Slovenian: vazospazem (redki)
English: Careful monitoring during the first cycle of treatment is recommended for all patients.
Slovenian: Skrbno spremljanje med. prvim ciklom zdravljenja je priporočljivo za vse bolnike.
English: A link between decreased levels of DPD and increased, potentially fatal toxic effects of 5-FU therefore cannot be excluded.
Slovenian: Povezave med zmanjšano vrednostjo DPD in povečanimi, potencialno smrtnimi toksičnimi učinki 5-FU tako ni mogoče izključiti.
English: Capecitabine SUN tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Slovenian: Tablete zdravila Kapecitabin SUN se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
English: Do not take Capecitabine SUN - if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Kapecitabin SUN - če ste alergični na kapecitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Slovenian: Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.