natgillin/translations-raw huggingface dataset:
Each dose of 2 ml contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs. 
inaktivirani virus IBR z delecijo gE, najmanj ..................................................................... 0,75 VN.U* .
ROUTE(S) OF ADMINISTRATION 
POTI(I) UPORABE ZDRAVILA
ADVICE ON CORRECT ADMINISTRATION See above. 
NASVET O PRAVILNI UPORABI ZDRAVILA
4.11 Withdrawal period(s) 
4.11 Karenca(e) Nič dni.
4.5 Special precautions for use 
NAVODILO ZA UPORABO ZA
SPECIAL WARNING(S) 
Adjuvans(i):
Adjuvant light paraffin oil .......................................................................................................... 449.6 to 488.2 mg 
lahko parafinsko olje .................................................................................................. 449,6 do 488,2 mg
Vaccinate only healthy animals. 
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
WITHDRAWAL PERIOD Zero days 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Lot 
FRANCIJA
The European Commission granted a marketing authorisation valid throughout the EU for Retacrit on 18 December 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Retacrit, veljavno po vsej Evropski uniji, odobrila dne 18. decembra 2007.
After that, the two groups switched to receiving the other medicine for a further 12 weeks. 
Nato so skupinama zamenjali zdravili za nadaljnjih 12 tednov.
This means that Retacrit is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine. 
To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU) in vsebuje podobno zdravilno učinkovino kot referenčno zdravilo.
The full EPAR for Retacrit 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) za zdravilo Retacrit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Retacrit: 
Druge informacije o zdravilu Retacrit:
Retacrit is used in the following situations: 
Zdravilo Retacrit se uporablja v naslednjih primerih:
It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin zeta. 
Proizvajajo jo z metodo, znano kot „tehnologija rekombinantne DNK“, proizvede jo celica, ki je prejela gen (DNK), s katerim lahko tvori epoetin zeta.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts. 
V teh primerih se eritropoetin uporablja za nadomestitev manjkajočega hormona ali za povečanje števila rdečih krvnih celic.
In both studies, the dose of epoetin received was similar with both medicines. 
V obeh študijah je bil odmerek prejetega epoetina pri obeh zdravilih podoben.
This document is a summary of the European Public Assessment Report (EPAR) for Retacrit. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Retacrit.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Retacrit. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Retacrit, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions; 
• za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in za zmanjšanje potrebe po transfuziji krvi;
For more information about treatment with Retacrit, read the Package Leaflet (also part of the EPAR). 
Za več informacij o zdravljenju z zdravilom Retacrit preberite navodilo za uporabo (ki je prav tako del EPAR).
What benefit has Retacrit shown during the studies? 
Kakšne koristi je zdravilo Retacrit izkazalo med študijami?
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children). 
Pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
Treatment with Retacrit must be started under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for. 
Zdravljenje z zdravilom Retacrit je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov, katerih bolezenska stanja se zdravijo s tem zdravilom.
What is the risk associated with Retacrit? 
Kakšna tveganja so povezana z zdravilom Retacrit?
The dose, the frequency of injection and how long Retacrit is used for depend on why it is being used, and are adjusted according to the patient's response. 
Odmerek, pogostnost injiciranja in trajanje zdravljenja z zdravilom Retacrit so odvisni od namena uporabe zdravila in jih je treba prilagoditi bolnikovemu odzivu.
The Committee recommended that Retacrit be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Retacrit odobri dovoljenje za promet.
It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta. 
Na voljo je v obliki napolnjene injekcijske brizge, ki vsebuje od 1 000 do 40 000 mednarodnih enot (i.e.) zdravilne učinkovine epoetin zeta.
Retacrit should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients. 
Zdravila Retacrit ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin zeta ali katero koli drugo sestavino zdravila.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment. 
Pred zdravljenjem je treba pri vseh bolnikih preveriti raven železa in s tem zagotoviti, da njihove vrednosti niso prenizke, med zdravljenjem pa morajo bolniki jemati dodatke, ki vsebujejo železo.
The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa. 
Referenčno zdravilo za zdravilo Retacrit je Eprex/Erypo, ki vsebuje epoetin alfa.
In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment. 
V zadnjih štirih tednih študije popravljanja so se ravni hemoglobina zvišale na okoli 11,6 g/dl s približno 8,0 g/dl pred zdravljenjem.
The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Retacrit primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The study in patients receiving chemotherapy showed that Retacrit brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins. 
V študiji pri bolnikih, ki so prejemali kemoterapijo, so dokazali, da je zdravilo Retacrit zagotovilo podobno izboljšanje ravni hemoglobina, kot je opisano v strokovni literaturi za druge epoetine.
In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received. 
V obeh študijah sta bili glavni merili učinkovitosti ravni hemoglobina med zdravljenjem in prejeti odmerek epoetina.
As with other medicines containing an epoetin, the most common side effect with Retacrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden stabbing migraine-like headache and confusion. 
Kot pri drugih zdravilih, ki vsebujejo epoetin, je najpogostejši neželeni učinek zdravila Retacrit zvišan krvni tlak, ki lahko v posameznih primerih povzroči simptome encefalopatije (možganskih zapletov), kot sta nenaden, migreni podoben, glavobol z zbadanjem in zmedenost.
It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots. 
Zdravilo se ne sme uporabljati pri bolnikih, pri katerih se je pojavila čista aplazija rdečih krvnih celic (zmanjšano ali prekinjeno nastajanje rdečih krvnih celic) po zdravljenju s katerim koli eritropoetinom, bolnikih s hipertenzijo (visokim krvnim tlakom), ki ni nadzorovana, bolnikih pred operacijo, ki imajo hude kardiovaskularne težave (težave s srcem in ožiljem), vključno z nedavnim miokardnim infarktom ali kapjo, ali pri bolnikih, ki ne smejo jemati zdravil za preprečevanje nastanka krvnih strdkov.
Retacrit must not be used prior to major bone surgery in patients who have a severe disease affecting their arteries or their blood vessels in the heart, neck or brain, including patients who have recently had a heart attack or stroke. 
Zdravilo Retacrit se ne sme uporabljati pred velikim operativnim posegom na kosteh pri osebah z resno boleznijo, ki je prizadela arterije ali krvne žile v srcu, vratu ali možganih, vključno z bolniki, ki so pred nedavnim utrpeli srčni napad ali kap.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. 
Pri bolnikih, ki prejemajo kemoterapijo ali imajo ledvične težave, lahko anemijo povzroči pomanjkanje eritropoetina ali premajhna odzivnost telesa na naravno prisotni eritropoetin.
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; 
• za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim zmanjševanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood). 
Zdravilo Retacrit, injicirano v veno, so z referenčnim zdravilom primerjali v dveh glavnih študijah, v kateri je bilo vključenih 922 bolnikov z anemijo, ki je bila povezana s kronično ledvično odpovedjo s potrebo po hemodializi (tehniki odstranjevanja odpadnih snovi iz krvi).
Retacrit is a ‘biosimilar' medicine. 
Zdravilo Retacrit je „biološko podobno“ zdravilo.
The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems. 
Družba je predstavila tudi rezultate dveh študij, v katerih so ugotavljali učinke podkožno injiciranega zdravila Retacrit: ena študija je vključevala 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi pa so primerjali zdravilo Retacrit z zdravilom Eprex/Erypo pri 462 bolnikih z anemijo kot posledico težav z ledvicami.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo. 
V študiji pri bolnikih, ki so se že zdravili z epoetinom, so ravni hemoglobina ostale na ravni približno 11,4 g/dl pri bolnikih, ki so prejemali zdravilo Retacrit ali zdravilo Eprex/Erypo.
For the full list of all side effects reported with Retacrit, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Retacrit, glejte navodilo za uporabo.
Retacrit is a solution for injection. 
Zdravilo Retacrit je raztopina za injiciranje.
Why has Retacrit been approved? 
Zakaj je bilo zdravilo Retacrit odobreno?
The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production. 
Zdravilna učinkovina v zdravilu Retacrit, epoetin zeta, je kopija človeškega eritropoetina in spodbuja tvorjenje rdečih krvnih celic povsem enako kot naravni hormon.
• to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery; 
• za povečanje količine krvi, ki jo lahko bolniki z zmerno slabokrvnostjo dajo pred operacijo in jo nato prejmejo med operacijo ali po njej;
Retacrit can be injected under the skin by the patient or their carer if they have been trained appropriately. 
Zdravilo Retacrit si lahko pod kožo vbrizga bolnik sam ali mu ga injicira negovalec, če sta bila za to ustrezno usposobljena.
Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Eprex/Erypo, odtehtajo znana tveganja.
• to reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement). 
• za zmanjšanje potrebe po transfuziji krvi pri bolnikih z zmerno slabokrvnostjo, ki so tik pred velikim operativnim posegom na kosteh (kot je vstavljanje kolka ali kolena).
Retacrit was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts. 
Zdravilo Retacrit je bilo enako učinkovito kot zdravilo Eprex/Erypo pri izboljševanju in ohranjanju ravni rdečih krvnih celic.
Erythropoietin is also used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation. 
Eritropoetin se uporablja tudi pred kirurškim posegom, da zviša ravni rdečih krvnih celic in tako pripomore k tvorbi večje količine lastne krvi, ki jo bolnik nato prejme med posegom.
All of the patients in the second study had been receiving treatment with Eprex/Erypo for at least three months before they were either switched to Retacrit or remained on Eprex/Erypo for 12 weeks. 
V drugi študiji so vse bolnike najmanj tri mesece zdravili z zdravilom Eprex/Erypo, nato pa so za 12 tednov bodisi zamenjali zdravilo z zdravilom Retacrit bodisi še naprej uporabljali zdravilo Eprex/Erypo.
Retacrit can also lead to skin rash and influenza (flu)-like symptoms. 
Zdravilo Retacrit lahko povzroči tudi kožne izpuščaje in gripi podobne simptome.
Retacrit was also as effective as the reference medicine in patients with kidney problems. 
Zdravilo Retacrit je bilo pri bolnikih z ledvičnimi težavami enako učinkovito kot referenčno zdravilo.
For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein. 
Pri bolnikih, ki prejemajo kemoterapijo, je treba zdravilo injicirati pod kožo, pri bolnikih pred kirurškim posegom pa v veno.
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. 
Hormon eritropoetin spodbuja nastajanje rdečih krvnih celic v kostnem mozgu.
Retacrit was also effective when it was injected under the skin. 
Zdravilo Retacrit je bilo učinkovito tudi ob podkožnem injiciranju.
How has Retacrit been studied? 
Kako je bilo zdravilo Retacrit raziskano?
For patients with kidney problems, Retacrit can be injected into a vein or under the skin. 
Zdravilo Retacrit je treba pri bolnikih z ledvičnimi težavami injicirati v veno ali pod kožo.
The second study compared the effects of Retacrit with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients. 
V drugi študiji so pri 313 bolnikih primerjali učinke zdravila Retacrit z učinki zdravila Eprex/Erypo pri ohranjanju ravni rdečih krvnih celic.
Retacrit was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans. 
Za zdravilo Retacrit so s pomočjo poskusnih modelov in pri ljudeh dokazovali, da je primerljivo z referenčnim zdravilom Eprex/Erypo.
What is Retacrit used for? 
Za kaj se zdravilo Retacrit uporablja?
How is Retacrit used? 
Kako se zdravilo Retacrit uporablja?
The first study compared the effects of Retacrit with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks. 
V prvi študiji so pri 609 bolnikih 24 tednov primerjali učinke zdravila Retacrit z učinki zdravila Eprex/Erypo pri izboljševanju ravni rdečih krvnih celic.
What is Retacrit? 
Kaj je zdravilo Retacrit?
How does Retacrit work? 
Kako zdravilo Retacrit deluje?
For full details, see the package leaflet. 
Za dodatne informacije glejte navodilo za uporabo.
The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom. 
Referenčna država članica je bila Nemčija, zadevni državi članici pa sta bili Finska in Združeno kraljestvo.
London, 21 August 2006 EMEA/CHMP/212746/2006 
London, 21. avgust 2006 EMEA/CHMP/212746/2006
A positive opinion was adopted by majority on 1 June 2006. 
Pozitivno mnenje je bilo sprejeto z večino glasov dne 1. junija 2006.
The Rapporteur was Dr. Broich and Co-Rapporteurs were Dr. Hudson and Dr. Kuitunen. 
Poročevalec je bil dr. Boich, soporočevalca pa sta bila dr. Hudson in dr. Kuitunen.
The arbitration procedure started on 15 September 2005 with the adoption of a list of questions. 
Arbitražni postopek se je začel 15. septembra 2005 s sprejetjem seznama vprašanj.
The Mutual Recognition Procedure started on 24 March 2005. 
Postopek za medsebojno priznavanje se je začel 24. marca 2005.
The United Kingdom referred the reasons for disagreement to the EMEA on 16 August 2005. 
Združeno kraljestvo je agenciji EMEA posredovalo razloge za nesoglasje dne 16. avgusta 2005.
This refers to the dosing recommendation for the newborn and this was considered to be of serious public health concern. 
Te se nanašajo na priporočila glede odmerjanja za novorojence, kar predstavlja resne pomisleke v zvezi z javnim zdravjem.
The Marketing Authorisation Holder provided written explanations on 28 November 2005. 
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 28. novembra 2005.
The posology in neonates where higher doses were proposed for neonates aged 15-27 days (80 mg/kg) while the standard dose is 20-50mg/kg in the UK for neonates 0-28 days. 
V zvezi z odmerjanjem pri novorojencih so bili predlagani višji odmerki za novorojence, stare od 15 do 27 dni (80 mg/kg), medtem ko je v Združenem kraljestvu standardni odmerek 20-50 mg/kg za novorojence, stare od 0 do 28 dni.
Significant difference has been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK. 
V zvezi s predlaganim Povzetkom glavnih značilnosti zdravila (SPC) so bile ugotovljene pomembne razlike v primerjavi s SPC referenčnega izdelka v Združenem kraljestvu.
During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should 
Med svojim zasedanjem maja 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ceftriaxone Tyrol Pharma in povezana imena ugodno, da ugovori, podani s strani Združenega
Depending on the mode of surgery and the expected spectrum of pathogens ceftriaxone should be combined with an appropriate antimicrobial agent with additional anaerobic coverage. 
Odvisno od vrste kirurškega posega in pričakovanega spektra patogenih mikroorganizmov je treba ceftriakson dajati skupaj z ustreznim protimikrobnim sredstvom, ki dodatno deluje na druge anaerobe.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(2)1 ZA Ceftriaxone Tyrol Pharma in povezana imena Mednarodno nelastniško ime (INN): Ceftriakson
It is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary: 
Indiciran je za zdravljenje spodaj navedenih okužb, kadar jih povzročijo na ceftriakson občutljivi organizmi in če je potrebno parenteralno zdravljenje:
not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. 
kraljestva, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
Ceftriaxone Tyrol Pharma and associated names, 1g and 2 g powder for solution for injection/infusion, is an antibiotic, being a third generation cephalosporin. 
Ceftriaxone Tyrol Pharma in povezana imena, 1g in 2 g prašek za raztopino za injiciranje/infundiranje je antibiotik, cefalosporin tretje generacije.
Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections. 
• pljučnica Ceftriakson se uporablja za preprečevanje okužb pri kirurških posegih pri bolnikih, pri katerih obstaja določeno tveganje, da pride do hudih okužb po operaciji.
Sandoz GmbH submitted applications for mutual recognition of Ceftriaxone Tyrol Pharma and associated names, 1g and 2g, solution for injection/infusion on the basis of the marketing authorisation granted by Germany on 13 August 2002. 
Družba Sandoz GmbH je predložila vloge za medsebojno priznavanje zdravila Ceftriaxone Tyrol Pharma in povezana imena, 1 g in 2 g prašek za raztopino za injiciranje/infundiranje, na osnovi dovoljenja za promet z zdravilom, ki ga je izdala Nemčija dne 13. avgusta 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Rixubis on 19 December 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Rixubis, veljavno po vsej Evropski uniji, izdala 19 decembra 2014.
It can be used in patients of all ages, and for short-term or long-term use. 
Uporablja se lahko pri bolnikih vseh starosti ter je primerno za kratkotrajno ali dolgotrajno uporabo.
What measures are being taken to ensure the safe and effective use of Rixubis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rixubis?
Other information about Rixubis 
Druge informacije o zdravilu Rixubis
The safety profile was considered acceptable and was outweighed by the beneficial effects. 
Varnostni profil je bil ocenjen kot sprejemljiv glede na koristi.
The full EPAR and risk management plan summary for Rixubis 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 Rixubis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.