natgillin/translations-raw huggingface dataset:
Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib. 
Med zdravljenjem z aksitinibom je treba redno spremljati znake ali simptome srčnega popuščanja.
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), 
• rdečina in otekanje dlani ali podplatov (sindrom dlani-podplatov), kožni izpuščaj, suha koža
EU/1/12/777/002 56 tablets 
EU/1/12/777/001 28 tablet EU/1/12/777/002 56 tablet
• Under-active thyroid gland (may show in your blood tests) 
• premalo dejavna žleza ščitnica (to se lahko pokaže pri preiskavah krvi)
• Hyper-active thyroid gland (may show in your blood tests) 
• preveč dejavna žleza ščitnica (to se lahko pokaže pri preiskavah krvi)
Median PFS a,b in months (95% CI) 
a,b v mesecih
Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 induction potential is recommended. 
Priporočljivo je izbrati drugo sočasno uporabljano zdravilo, ki ne inducira ali minimalno inducira CYP3A4/5.
In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%). 
Perforacija prebavil in nastanek fistule (glejte poglavje 4.4) V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so o dogodkih tipa perforacije prebavil poročali pri 1,7 % bolnikov, ki so prejemali aksitinib; ti so vključevali analno fistulo (0,6 %), fistulo (0,3 %) in perforacijo prebavil (0,3%).
Very common Decreased appetite Common 
Presnovne in prehranske motnje zelo pogosti zmanjšan apetit pogosti dehidracija hiperkaliemija hiperkalciemija
EU/1/12/777/005 56 tablets 
EU/1/12/777/004 28 tablet EU/1/12/777/005 56 tablet
Your doctor should monitor for signs or symptoms of heart failure events periodically throughout treatment with axitinib. 
Med zdravljenjem z aksitinibom bo zdravnik redno spremljal znake ali simptome srčnega popuščanja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib. 
Inlyta 1 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1 mg aksitiniba.
Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib. 
Med zdravljenjem z aksitinibom je potrebno redno spremljanje glede morebitnega pojava simptomov perforacije prebavil ali nastanka fistule.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg axitinib. 
Ena filmsko obložena tableta vsebuje 1 mg aksitiniba.
Uncommon Posterior reversible encephalopathy syndromee 
Bolezni živčevja zelo pogosti glavobol disgevzija pogosti omotica občasni sindrom posteriorne reverzibilne encefalopatije
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema pogosti anemija trombocitopenija policitemija občasni nevtropenija levkopenija
Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8). 
Krvavitve V kliničnih preskušanjih z aksitinibom so poročali o pojavu krvavitev (glejte poglavje 4.8).
NAME OF THE MEDICINAL PRODUCT Inlyta 7 mg film-coated tablets axitinib 
Inlyta 7 mg filmsko obložene tablete aksitinib
In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.4% of patients receiving axitinib. 
Policitemija (glejte Zvišanje ravni hemoglobina ali hematokrita v poglavju 4.4) V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so o policitemiji poročali pri 1,4 % bolnikov, ki so prejemali aksitinib.
Uncommon Neutropaenia Leukopaenia 
Neželeni učinki na jetra
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 7 mg axitinib. 
Ena filmsko obložena tableta vsebuje 7 mg aksitiniba.
‘Secondary' means that it is caused by another condition. 
„Sekundarni“ pomeni, da nastane kot posledica drugega bolezenskega stanja.
The full EPAR and risk management plan summary for Cinacalcet Mylan 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 Cinakalcet Mylan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of calcium in the blood, bone and joint pain and deformities of the arms and legs. 
Hiperparatiroidizem je stanje, pri katerem obščitnice v vratu tvorijo preveč paratiroidnega hormona (PTH), kar lahko povzroči visoke ravni kalcija v krvi, bolečine v kosteh in sklepih ter deformacije rok in nog.
This is a summary of the European public assessment report (EPAR) for Cinacalcet Mylan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cinakalcet Mylan.
What measures are being taken to ensure the safe and effective use of Cinacalcet Mylan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cinakalcet Mylan?
• treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. 
• za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resnim obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi potrebujejo dializo.
Cinacalcet Mylan is available as 30, 60 and 90 mg tablets. 
Zdravilo Cinakalcet Mylan je na voljo v obliki tablet (30, 60 in 90 mg).
Cinacalcet Mylan can be used as part of treatment including phosphate binders or vitamin D; 
Zdravilo Cinakalcet Mylan se lahko uporablja kot del zdravljenja, ki vključuje vezalce fosfatov ali vitamin D;
The reduction in PTH levels leads to a decrease in blood calcium levels. 
Zmanjšanje ravni paratiroidnega hormona privede do znižanja ravni kalcija v krvi.
Cinacalcet Mylan is taken with food or shortly after a meal. 
Zdravilo Cinakalcet Mylan se jemlje s hrano ali kmalu po obroku.
‘Primary' means that the hyperparathyroidism is not caused by any other condition. 
„Primarni“ pomeni, da ni posledica nobenega drugega bolezenskega stanja.
What are the benefits and risks of Cinacalcet Mylan? 
Kakšne so koristi in tveganja, povezani z zdravilom Cinakalcet Mylan?
A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Cinakalcet Mylan je bil pripravljen načrt obvladovanja tveganj.
• reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that their removal is not appropriate. 
• za zmanjšanje hiperkalciemije (visokih ravni kalcija v krvi) pri bolnikih s paratiroidnim karcinomom (rakom obščitnic) ali s primarnim hiperparatiroidizmom, pri katerih obščitnic ni mogoče odstraniti oziroma zdravnik meni, da njihova odstranitev ni primerna.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Cinacalcet Mylan has been shown to have comparable quality and to be bioequivalent to Mimpara. 
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 Cinakalcet Mylan primerljivo raven kakovosti kot zdravilo Mimpara ter da mu je biološko enakovredno.
The Committee recommended that Cinacalcet Mylan be approved for use in the EU. 
Priporočil je, da se zdravilo Cinakalcet Mylan odobri za uporabo v EU.
Because Cinacalcet Mylan 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 Cinakalcet Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
For more information about treatment with Cinacalcet Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cinakalcet Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
This means that Cinacalcet Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU). 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Mimpara.
For practical information about using Cinacalcet Mylan, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Cinakalcet Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months. 
Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa redno na en do tri mesece.
Cinacalcet Mylan contains the active substance cinacalcet and is a ‘generic medicine'. 
Zdravilo Cinakalcet Mylan vsebuje zdravilno učinkovino cinakalcet in je „generično zdravilo“.
Because Cinacalcet Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mimpara. 
Ker je zdravilo Cinakalcet Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Mimpara.
Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Cinacalcet Mylan. 
Ravni kalcija v krvi je treba meriti pogosto in v prvem tednu po vsaki prilagoditvi odmerka zdravila Cinakalcet Mylan.
Cinacalcet Mylan cinacalcet 
Cinakalcet Mylan cinakalcet
Cinacalcet Mylan is a medicine used in adults and older patients to: 
Zdravilo Cinakalcet Mylan se uporablja pri odraslih in starostnikih:
Therefore, the CHMP's view was that, as for Mimpara, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Mimpara odtehtajo znana tveganja.
Other information about Cinacalcet Mylan 
Druge informacije o zdravilu Cinakalcet Mylan
The active substance in Cinacalcet Mylan, cinacalcet, works by increasing the sensitivity of the calciumsensing receptors on the parathyroid glands that regulate PTH secretion. 
Zdravilna učinkovina v zdravilu Cinakalcet Mylan, cinakalcet, deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki se nahajajo na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
What is Cinacalcet Mylan and what is it used for? 
Kaj je zdravilo Cinakalcet Mylan in za kaj se uporablja?
PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Cinacalcet Mylan. 
Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka zdravila Cinakalcet Mylan in en do štiri tedne po vsaki prilagoditvi odmerka.
It is not intended to provide practical advice on how to use Cinacalcet Mylan. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Cinacalcet Mylan approved? 
Zakaj je bilo zdravilo Cinakalcet Mylan odobreno?
The dose of Cinacalcet Mylan should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels. 
Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom je priporočeni začetni odmerek zdravila Cinakalcet Mylan za odrasle 30 mg dvakrat na dan. Odmerek zdravila Cinakalcet Mylan je treba povečevati vsakih dva do štiri tedne do vrednosti 90 mg tri- ali štirikrat dnevno, če je potrebno za znižanje ravni kalcija v krvi na normalno raven.
The dose is adjusted every two to four weeks, according to the patient's PTH levels, up to a maximum of 180 mg once a day. 
Pri sekundarnem hiperparatiroidizmu je priporočeni začetni odmerek za odrasle 30 mg enkrat na dan. Odmerek se prilagodi vsakih dva do štiri tedne v skladu z bolnikovimi ravnmi paratiroidnega hormona in lahko znaša največ 180 mg enkrat na dan.
How has Cinacalcet Mylan been studied? 
Kako je bilo zdravilo Cinakalcet Mylan raziskano?
How is Cinacalcet Mylan used? 
Kako se zdravilo Cinakalcet Mylan uporablja?
How does Cinacalcet Mylan work? 
Kako zdravilo Cinakalcet Mylan deluje?
Strength 
Stična ovojnina
The following deficiencies were identified: 
Odkrili sta naslednje pomanjkljivosti:
In addition, any significant safety events may only develop after a long period of time. 
Poleg tega se utegnejo morebitni pomembni varnostni dogodki pojaviti šele po daljšem času.
SoliCol D3 
Zdravilo SoliCol D3
The consistent and continuous lack of adequate quality assurance since before 2015 is therefore of serious concern. 
Stalno in nenehno pomanjkanje ustreznega zagotavljanja kakovosti iz obdobja pred letom 2015 je zato zelo zaskrbljujoče.
The DHPCs should be sent in accordance with the agreed communication plan. 
Neposredna obvestila je treba poslati v skladu z dogovorjenim načrtom sporočanja.
In addition to the measures already implemented following the initial MHRA inspection in June 2015, further quality actions are currently on-going to improve the quality systems in place at the manufacturing site. 
Poleg že izvedenih ukrepov po začetnem inšpekcijskem pregledu agencije MHRA junija 2015 se trenutno izvajajo dodatni ukrepi v zvezi z izboljšanjem sistemov kakovosti v proizvodnem obratu.
The reliability of the safety database to detect such an effect is very low. 
Zanesljivost zbirke podatkov o varnosti zdravila je za odkrivanje takega učinka zelo majhna.
The CHMP was requested to issue an opinion as to whether marketing authorisations of the medicinal products that include the above mentioned site should be maintained, varied, suspended, or revoked. 
Odbor CHMP je bil zaprošen, naj poda mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki zadevajo zgoraj omenjen obrat, ohranijo, spremenijo, začasno umaknejo ali ukinejo.
Nevertheless, the quality system at the manufacturing site is still significantly lacking in terms of change control and quality oversight. 
Kljub temu pa je sistem kakovosti v proizvodnem obratu z vidika nadzora nad spremembami in nadzora nad kakovostjo še vedno zelo pomanjkljiv.
This is a severe condition and a significant number of patients are treated with Ammonaps in the EU. 
To je resno stanje in v EU se z zdravilom Ammonaps zdravi precejšnje število bolnikov.
SoliCol D3 was approved in the UK through a national procedure on 18 December 2015. 
Zdravilo SoliCol D3 je dovoljenje za promet v Združenem kraljestvu pridobilo 18. decembra 2015 po nacionalnem postopku.
Further testing of the product on importation in the EU was also put in place with a new set of analytical results being generated prior to the release. 
Ob uvozu v EU je bilo vzpostavljeno dodatno preskušanje zdravila, pri čemer se pred sproščanjem pripravi nov sklop analitskih rezultatov.
Grounds for CHMP opinion Whereas 
Podlaga za mnenje odbora CHMP
• Major deficiencies relating to organisational data governance failures, sterilisation and depyrogenation processes, and insufficient control of aseptic operations to provide the required level of sterility assurance. 
• večje pomanjkljivosti v zvezi z neuspešnim organizacijskim upravljanjem podatkov, procesoma sterilizacije in depirogenizacije ter nezadostnim nadzorom nad aseptičnimi operacijami za zagotavljanje ustrezne ravni zagotavljanja sterilnosti.
• Critical deficiencies relating to the failure of organisational and technical measures to minimise the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment, as well as failures of the quality unit to ensure the effective operation of the quality system; 
• kritične pomanjkljivosti v zvezi z neuspešnimi organizacijskimi in tehničnimi dejavnostmi za zmanjševanje tveganja za navzkrižno kontaminacijo med nevarnimi in nenevarnimi izdelki, ki se proizvajajo v istih proizvodnih obratih z isto opremo, ter nezmožnost enote za kakovost zagotoviti učinkovito delovanje sistema kakovosti;
A detailed assessment of all product complaint reports over the past 5 years provided by the MAH did not reveal any product complaint that could be associated to potential cross contamination. 
Podrobna ocena vseh poročil o pritožbah glede zdravila v zadnjih petih letih, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ni odkrila nobene pritožbe glede zdravila, ki bi bila povezana z morebitno navzkrižno kontaminacijo.
These measures include the use of assistance from experienced external specialists specialised in Quality management and an enhanced control of the batch documents by the Qualified Person at the EEA site responsible for batch release. 
Ti ukrepi vključujejo uporabo pomoči izkušenih zunanjih strokovnjakov za upravljanje kakovosti in okrepljen nadzor nad dokumenti o serijah s strani usposobljene osebe v obratu v EGP, odgovorne za sproščanje serij.
The sourcing of Lutinus from PII has stopped in 2014 and the manufacturing of the product fully switched to an alternative site registered in December 2013. 
Nabava zdravila Lutinus od družbe PII se je leta 2014 ustavila, proizvodnja zdravila pa se je v celoti premaknila v drug obrat, registriran decembra 2013.
• The CHMP reviewed the inspection report provided by the Supervisory Authority, the (co-) rapporteur's assessment reports and the available data presented by the MAHs in writing in response to questions addressed by the CHMP; 
• odbor CHMP je pregledal poročilo inšpekcijskega pregleda, ki ga je predložil nadzorni organ, poročila o oceni (so)poročevalca in razpoložljive podatke, ki so jih pisno predložili imetniki dovoljenj za promet z zdravili v odgovor na vprašanja, ki jih je zastavil odbor;
This product was approved in the EU via a decentralised procedure including all 28 Member States, with Sweden acting as reference Member State. 
To zdravilo je dovoljenje za promet v EU pridobilo po decentraliziranem postopku, ki je vključeval vseh 28 držav članic, pri čemer je bila v vlogi referenčne države članice Švedska.
It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). 
Indicirano je pri vseh bolnikih, pri katerih se bolezen pojavi v neonatalni fazi (popolno pomanjkanje encima, ki se pojavi v prvih 28 dneh življenja).
Lutinus is a vaginal tablet containing 100 mg progesterone, indicated for luteal support as part of treatment program for infertile women. 
Zdravilo Lutinus je na voljo v obliki vaginalne tablete, ki vsebuje 100 mg progesterona, in je indicirano za lutealno podporo kot del programa zdravljenja neplodnosti pri ženskah.
Ammonaps is available as white oval tablets (500 mg) and as granules (940 mg/g). 
Zdravilo Ammonaps je na voljo v obliki belih ovalnih tablet (500 mg) in v obliki zrnc (940 mg/g).
SoliCol D3 20,000 IU tablets and SoliCol D3 50,000 IU tablets are medicinal products containing 20,000 or 50000 IU colecalciferol (vitamin D3 analogue) as active substance. 
Zdravili SoliCol D3 20 000 i.e. tablete in SoliCol D3 50 000 i.e. tablete kot zdravilno učinkovino vsebujeta 20 000 oziroma 50 000 i.e. holekalciferola (analoga vitamina D3).
A detailed assessment of cumulative safety data on Lutinus up to 31 May 2016 was also performed which did not raise any significant safety concerns related to GMP non-compliance. 
Opravljena je bila tudi podrobna ocena kumulativnih podatkov o varnosti zdravila Lutinus do 31. maja 2016, pri kateri niso odkrili nobenih pomembnih pomislekov o varnosti, povezanih z neskladnostjo z dobro proizvodno prakso.
Further, patients need life-long treatment and other available treatment options appear limited, because of concerns over the supply of alternatives and the fact that some of these cannot be administered via naso-gastric/gastrostomy tubes, which is often needed in these patients. 
Poleg tega bolniki potrebujejo zdravljenje, ki traja vse življenje, druge možnosti zdravljenja pa so omejene, in sicer zaradi pomislekov pri dobavi drugih možnosti in dejstva, da nekaterih med njimi ni mogoče dajati z nazogastrično sondo oziroma gastrostomo, ki ju ti bolniki pogosto potrebujejo.
Furthermore, the CHMP recommended that in due course, appropriate communications should be issued and proposed Direct Healthcare Professional Communications (DHPC) to inform on the outcome of the review and the conclusions reached concerning the use of Ammonaps. 
Nadalje je odbor CHMP priporočil, da se pravočasno izdajo ustrezna obvestila, in predlagal, da se z neposrednimi obvestili za zdravstvene delavce ti obvestijo o izidu pregleda in zaključkih o uporabi zdravila Ammonaps.
It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy. 
Indicirano je tudi pri bolnikih z zapoznelim pojavom bolezni (delno pomanjkanje encima, ki se pojavi po prvem mesecu življenja), ki imajo anamnezo hiperamonemične encefalopatije.
In addition, Ammonaps should not be used if an alternative treatment option is available and appropriate for the patient. 
Zdravilo Ammonaps se ne sme uporabljati, če obstaja druga možnost zdravljenja, primerna za bolnika.
Given that all EU Member States are currently supplied with Lutinus manufactured at the alternative manufacturing site, no shortage is foreseen for this product. 
Ker trenutno vse države članice EU nabavljajo zdravilo Lutinus, proizvedeno v drugem proizvodnem obratu, pomanjkanje tega zdravila ni predvideno.
Although no reports of cross-contamination have been reported in the post-marketing setting, taking into account the target population, that is severely ill and the small patient population (as the prevalence of the condition is very low), the lack of such reports only provides a low degree of reassurance. 
Čeprav iz obdobja trženja ni poročil o navzkrižni kontaminaciji, ob upoštevanju ciljne populacije, ki je kritično bolna, in majhne populacije bolnikov (saj je prevalenca bolezni zelo majhna) pomanjkanje tovrstnih poročil ni zadostno zagotovilo.
Pharmaceutics International Inc. (PII), located in Maryland, USA is listed as manufacturer in the marketing authorisation of four products authorised in the EU, including the centrally approved product Ammonaps and three nationally approved products: Lutinus, Dutasteride Actavis and SoliCol D3. 
Družba Pharmaceutics International Inc. (PII) iz Marylanda v ZDA je v dovoljenjih za promet z zdravili navedena kot izdelovalec štirih zdravil z dovoljenjem za promet v EU, vključno z zdravilom Ammonaps, ki je dovoljenje pridobilo po centraliziranem postopku, in tremi zdravili, ki so dovoljenje pridobila po nacionalnem postopku: Lutinus, Dutasteride Actavis in SoliCol D3.