FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant provided with the grounds for re-examination revised Summary of Product Characteristics (SmPC) and risk management plan (RMP) proposals.
Slovenian: Predlagatelj je hkrati z razlogi za ponovni pregled predložil tudi popravljena osnutka povzetka glavnih značilnosti zdravila in načrta za obvladovanje tveganja.
English: Phentermine's mechanism of action was a concern as it has sympathomimetic properties inducing cardiac stimulation and its use is associated with an increase in heart rate.
Slovenian: Mehanizem delovanja fentermina je predstavljal zadržek zaradi svojega simpatikomimetičnega delovanja, vključno s stimulacijo srca, njegova uporaba pa je povezana s pospešenjem srčnega utripa.
English: Phentermine's mechanism of action is of concern as it has sympathomimetic properties inducing cardiac stimulation and its use is associated with an increase in heart rate.
Slovenian: Mehanizem delovanja fentermina predstavlja zadržek zaradi svojega simpatikomimetičnega delovanja, vključno s stimulacijo srca, njegova uporaba pa je povezana s pospešenjem srčnega utripa.
English: Furthermore, the applicant cited the example of topiramate as further evidence that this risk can be effectively mitigated by SmPC and RMP.
Slovenian: Poleg tega je predlagatelj v povzetku glavnih značilnosti zdravila in načrtu za obvladovanje tveganja navedel primer topiramata kot dodaten dokaz, da je to tveganje mogoče učinkovito omiliti.
English: Reduction of weight can be assumed as surrogate parameter for a beneficial cardiovascular (CV) outcome and current EMA guidance on medicinal products used in weight control does not require demonstration of a positive effect on CV morbidity and mortality prior to approval.
Slovenian: trenutni napotki Evropske agencije za zdravila v zvezi z zdravili za nadzor telesne mase pa ne zahtevajo prikaza pozitivnega učinka na kardiovaskularno obolevnost in smrtnost pred odobritvijo zdravila.
English: The probability of off-label use - A robust SmPC and state-of-the art education-based RMP, further strengthened by the use of comprehensive prescriber checklist and patient education card, was proposed to be put in place by the applicant to be uniformly and easily implementable across all EU countries.
Slovenian: ki bi ju dodatno podkrepila uporaba izčrpnega kontrolnega seznama za predpisovalca zdravila in informativne kartice za bolnika, in ki bi bila na enoten in enostaven način uvedljiva v vseh državah EU.
English: Overall, the availability of psychiatric expertise at sites of treatment with Qsiva was considered to be necessary by CHMP.
Slovenian: V splošnem je odbor CHMP presodil, da mora biti v ustanovah, kjer se za zdravljenje uporablja zdravilo Qsiva, na razpolago možnost psihiatričnega strokovnega mnenja.
English: 30 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidaemia.
Slovenian: Zdravilo Qsiva je priporočljivo za bolnike s čezmerno telesno maso (ITM ≥ 35 kg/m2) in bolnike s čezmerno telesno maso (ITM ≥ 30 kg/m2), ki imajo zdravstvene težave, povezane s telesno maso, npr. hipertenzijo, sladkorno bolezen tipa 2 ali dislipidemijo.
English: The mean change from baseline to Week 108 in heart rate was also higher in the Qsiva groups (1.3 bpm and 1.7 bpm, respectively) than in the placebo group (0.4 bpm).
Slovenian: 108. tedna je bila večja v skupinah z zdravilom Qsiva (1,3 utripa na minuto oziroma 1,7 utripa na minuto)
English: The applicant presented in writing and at an oral explanation their grounds that the adopted CHMP Opinion may not have considered the data fully and also provided further analyses to support the clinical safety of Qsiva in the proposed indication.
Slovenian: Razloge za ponovni pregled je predlagatelj obrazložil pisno in ustno, in sicer da mnenje odbora CHMP morda ni v celoti upoštevalo podatkov.
English: Therefore the cardiovascular effects of Qsiva cannot be implied from data for higher doses of phentermine as a single agent.
Slovenian: Zato iz podatkov za večje odmerke fentermina pri monoterapiji ni mogoče sklepati o kardiovaskularnih učinkih zdravila Qsiva.
English: Obesity, including weight loss and maintenance of weight loss in adults, as an adjunct to reduced calorie diet and physical activity.
Slovenian: Glede na znanstveni zaključek, ki ga je odbor CHMP sprejel 18. oktobra 2012 zdravila Qsiva ni mogoče odobriti za zdravljenje debelosti, vključno z izgubo telesne mase in vzdrževanjem izgube telesne mase pri odraslih, kot dodatek k dieti z majhnim vnosom kalorij in telesni dejavnosti.
English: Pregnancies have been reported in rather high numbers in the clinical trial program raising concerns with regard to the teratogenic risk of the product when used in a less controlled real life setting;
Slovenian: Poleg tega kognitivni učinki take kombinacije v obdobju dolgotrajnega zdravljenja ostajajo nejasni brez ustreznih študij; 3. so v programu kliničnega preskušanja o nosečnostih poročali v precej velikem številu in izpostavili zadržke glede teratogenega tveganja zdravila, kadar se uporablja v manj kontroliranih okoliščinah v realnem življenju;
English: Estimates of the mean heart rate were considered by CHMP not to be necessarily the most relevant parameter (compared to e.g. increase in heart rate in the highest percentile or increased proportion of subjects with > 10 bpm) The consequence of the sympathomimetic mechanism of action of Qsiva for CV outcome in long-term use remains a principle concern for CHMP in the absence of long-term CV outcome trial data.
Slovenian: Odbor CHMP je presodil, da ocene povprečnega srčnega utripa niso nujno najpomembnejši parameter (npr. v primerjavi s pospešenjem srčnega utripa v najvišjem percentilu ali s povečanim deležem preiskovancev z > 10 utripi na minuto).
English: The Rapporteur was Dr. Salmonson and the Co-Rapporteur was Dr Abadie.
Slovenian: Poročevalec je bil dr. Salmonson, soporočevalec pa dr. Abadie.
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, The Netherlands, Poland, Portugal, Slovakia and United Kingdom and Norway and Iceland.
Slovenian: Referenčna država članica je bila Švedska, zadevne države članice pa Avstrija, Belgija, Ciper, Češka republika, Danska, Estonija, Nemčija, Grčija, Španija, Finska, Francija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Poljska, Portugalska, Slovaška in Združeno kraljestvo ter Norveška in Islandija.
English: The final opinion was converted into a Decision by the European Commission on 13 December 2006.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 13. decembra 2006.
English: The Mutual Recognition Procedure started on 18 October 2005.
Slovenian: Postopek medsebojnega priznavanja se je začel 18. oktobra 2005.
English: The arbitration procedure started on 27 April 2006 with the adoption of a list of questions.
Slovenian: Arbitražni postopek se je začel dne 27. aprila 2006 s sprejetjem seznama vprašanj.
English: Sweden referred the reasons for disagreement to the EMEA on 31 March 2006.
Slovenian: Švedska je svoje razloge za nestrinjanje posredovala agenciji EMEA dne 31. marca 2006.
English: These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Omenjene države članice niso mogle doseči soglasja glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: A positive opinion was adopted by y a majority of 19 out of 27 votes on 21 September 2006.
Slovenian: Dne 21. septembra 2006 je bilo tako z večino 19 glasov od skupaj 27 sprejeto pozitivno mnenje.
English: The Marketing Authorisation Holder provided written explanations on 21 July 2006.
Slovenian: Imetnik dovoljenja za promet je podal svoja pisna pojasnila 21. julija 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Glucomed and associated names International Non-Proprietary Name (INN): glucosamine hydrochloride
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(4)1 za Glucomed in z njim povezana imena Mednarodno nelastniško ime (INN): glukozaminijev hidroklorid
English: The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “relief of symptoms in mild to moderate osteoarthritis of the knee”.
Slovenian: Od predlagatelja so zahtevali, da dokaže učinkovitost glukozamina pri predvideni indikaciji “lajšanje simptomov blagega do zmernega osteoartritisa kolena”.
English: In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions, to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/benefit profile of glucosamine hydrochloride in the intended indication.
Slovenian: Poleg tega so predlagatelja tudi zaprosili, da utemelji predlagani odmerek in način odmerjanja, opredeli varnostni profil zdravila, vključno z razpravo o opaženih neželenih učinkih zdravila, utemelji relevantnost literature, ker formulacije glukozaminijevega sulfata (v obliki kompleksa z natrijevim kloridom), uporabljene v citirani literaturi, niso enake zadevni formulaciji za uporabo zdravila ter navede, ali bodo razlike v formulaciji vplivale na učinkovitost in varnost zdravila, opredeli možnost interakcij z drugimi zdravili in končno tudi dokaže pozitivno razmerje med koristmi in tveganji uporabe glukozaminijevega hidroklorida pri predvideni indikaciji.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen tega zdravila je podan v Dodatku I, znanstveni zaključki pa v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila, označevanjem in navodili za uporabo v Dodatku III.
English: Glucosamine was mainly introduced on the world-wide market as a foodsupplement but with the aim to improve symptoms in patients with osteoarthritis or joint pain or function.
Slovenian: Glukozamin so začeli tržiti po vsem svetu kot prehransko dopolnilo, vendar z namenom lajšanja simptomov pri bolnikih z osteoartritisom ali bolečin v sklepih ali z namenom izboljšanja funkcije sklepov.
English: During their September 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 Glucomed and associated names for the relief of symptoms in mild to moderate osteoarthritis of the knee, that there was no objection for the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State
Slovenian: Na sestanku v septembru 2006 je bil CHMP ob upoštevanju vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Glucomed in z njim povezana imena za lajšanje simptomov blagega do zmernega osteoartritisa kolena ugodno, da ni nikakršnih zadržkov za izdajo dovoljenja za promet z zdravilom in da je treba Povzetek glavnih
English: Glucomed and associated names, 625 mg, tablet, contains glucosamine which is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans.
Slovenian: Zdravilo Glucomed in z njim povezana imena, 625 mg tablete, vsebujejo glukozamin, ki je endogena snov in je običajen gradnik polisaharidnih verig v hrustančnem matriksu in glikozaminoglikanov v sinovijski tekočini.
English: Navamedic ASA submitted applications for mutual recognition of Glucomed and associated names, 625 mg, tablet on the basis of the marketing authorisation granted by Sweden on 4 August 2005.
Slovenian: Na podlagi dovoljenja za promet z zdravilom, izdanega na Švedskem 4. avgusta 2005, je družba Navamedic ASA podala vloge za medsebojno priznavanje zdravila Glucomed in z njim povezanih imen, 625 mg tablete.
English: This summary was last updated in: 04-2013.
Slovenian: Ta povzetek je bil nazadnje posodobljen 04-2013.
English: EMA/281953/2007 EMEA/V/C/000038
Slovenian: EMEA/V/C/000038
English: Immunity starts after three weeks and lasts for three months.
Slovenian: Imunost se razvije po treh tednih in traja tri mesece.
English: This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks.
Slovenian: Po prvi injekciji lahko v premeru meri do 2 cm, po drugi injekciji pa do 5 cm, vendar navadno izgine v treh tednih.
English: The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk.
Slovenian: Protitelesa se od samice na pujska prenašajo tudi prek kolostruma (prvega mleka) in mleka.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a diseases.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) naučijo, kako naj se brani pred boleznijo.
English: Wash and disinfect hands and equipment after use.
Slovenian: Po uporabi si operite in razkužite roke ter opremo.
English: The vaccine also contains ‘adjuvants' (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.
Slovenian: Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij, mineralno olje, emulgator in detergent) za stimulacijo boljšega odziva.
English: Live attenuated Aujeszky's Disease Virus
Slovenian: Živý atenuovaný vírus Aujeszkyho choroby
English: Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger.
Slovenian: Nenamerno injiciranje lahko povzroči hudo bolečino in oteklino, še zlasti v primeru nenamernega injiciranja v sklep ali prst.
English: This protects the pigs against the disease.
Slovenian: To pomaga zaščititi prašiče pred boleznijo.
English: Breeding boars (male pigs) should be revaccinated every six months.
Slovenian: Plemenske merjasce (samce) je treba ponovno cepiti vsakih šest mesecev.
English: It prevents death and symptoms of the disease and reduces the shedding of the virus.
Slovenian: Cepivo preprečuje pogin in simptome bolezni ter zmanjšuje izločanje virusa.
English: Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth.
Slovenian: Plemenske samice je treba ponovno cepiti pred prvim parjenjem ali med vsako brejostjo, tri do šest tednov pred skotitvijo.
English: The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker.
Slovenian: Virus je bil gensko spremenjen: odstranjen je bil eden izmed genov (gen, ki omogoča tvorjenje encima timidin kinaza), zato je virus šibkejši.
English: To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months.
Slovenian: Za cepljenje cele črede se priporoča dajanje enega odmerka vsakemu plemenskemu samcu in samici vsake štiri mesece.
English: The studies compared the levels of infection in vaccinated and unvaccinated pigs.
Slovenian: V raziskavah so primerjali stopnjo okužbe pri cepljenih in necepljenih prašičih.
English: When a pig is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašič prejme cepivo, imunski sistem prepozna oslabljene viruse kot tujke in proti njim razvije protitelesa.
English: In case of accidental injection, seek prompt medical advice and show the Package Leaflet to the doctor.
Slovenian: V primeru nenamernega injiciranja nemudoma poiščite medicinsko pomoč in pokažite zdravniku Navodilo za uporabo.
English: After vaccination, the number of pig herds with signs of infection fell significantly, as did the number of infected pigs within the herds.
Slovenian: Po cepljenju je število čred prašičev z znaki okužbe, pa tudi število okuženih prašičev v čredah, znatno upadlo.
English: In up to a half of pigs being vaccinated, a slight temporary reaction can occur at the site of injection.
Slovenian: Pri največ polovici cepljenih prašičev se lahko na mestu injiciranja pojavi blaga prehodna reakcija.
English: The herds of pigs were monitored for signs of infection with the type of Aujeszky's disease virus that is can be caught in the field.
Slovenian: V čredah prašičev so spremljali znake okužbe s vrsto virusa Aujeszkyjeve bolezni, s katerim se je mogoče okužiti v okolju.
English: An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.
Slovenian: Pri manjšem številu prašičev lahko telesna temperatura naraste do približno 40,5°C.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Slovenian: Ko bo imunski sistem naslednjič izpostavljen virusom, bo lahko hitreje izdelal protitelesa.
English: Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/W can also result in immunity in the pig's offspring.
Slovenian: Cepljenje mladic (samic, ki še niso imele pujskov) in svinj (samic, ki so že imele pujske) z zdravilom Suvaxyn Aujeszky 783 + O/W lahko privede tudi do imunosti njihovih potomcev.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
English: This enables the piglets of vaccinated pigs to be protected against the disease.
Slovenian: To omogoča, da so pujski cepljenih samic zaščiteni pred boleznijo.
English: The effectiveness of Suvaxyn Aujeszky 783 + O/W has been studied in a large number of pigs in several farms in studies lasting around two years.
Slovenian: Učinkovitost zdravila Suvaxyn Aujeszky 783 + O/W so preučevali pri velikem številu prašičev na različnih farmah v okviru raziskav, ki so trajale približno dve leti.
English: There was no change in the infection rates in the pigs that were not vaccinated.
Slovenian: Pri necepljenih prašičih sprememb v stopnjah okužbe ni bilo.
English: Suvaxyn Aujeszky 783 + O/W is given as two 2 ml injections into the muscle of the neck behind the ear, three to four weeks apart.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W se daje v obliki dveh 2 ml injekcij v mišico vratu za ušesom v razmiku treh do štirih tednov.
English: Suvaxyn Aujeszky 783 + O/W was effective at preventing infection with the virus.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W je bilo učinkovito pri preprečevanju okužbe z virusom.
English: Suvaxyn Aujeszky 783 + O/W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W je prašek in topilo za pripravo emulzije (zmes tekočin na osnovi olja in vode) za injiciranje.
English: Suvaxyn Aujeszky 783 + O/W is used to vaccinate pigs from the age of 10 weeks against Aujeszky's disease, an illness similar to rabies that is caused by a herpesvirus.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W se uporablja za cepljenje prašičev, starih 10 tednov ali več, proti Aujeszkyjevi bolezni, tj. bolezni, podobni steklini, ki jo povzroča herpesvirus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/W exceed the risks for the treatment of active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Suvaxyn Aujeszky 783 + O/W pri aktivni in pasivni imunizaciji prašičev za preprečevanje ali zmanjševanje pogina in kliničnih znakov Aujeszkyjeve bolezni in za zmanjšanje izločanja divjega virusa Aujeszkyjeve bolezni večje od z njim povezanih tveganj.
English: Suvaxyn Aujeszky 783 + O/W contains small amounts of a weakened form of the virus that causes Aujeszky's disease.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W vsebuje majhne količine oslabljene oblike virusa, ki povzroča Aujeszkyjevo bolezen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn Aujeszky 783 + O/W on 7 August 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn Aujeszky 783 + O/W, veljavno po vsej Evropski uniji, odobrila dne 7. avgusta 1998.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Slovenian: Koliko časa je potrebno počakati preden se žival lahko zakolje in meso uporabi za prehrano ljudi (karenca)?
English: Suvaxyn Aujeszky 783 + O/W is a vaccine that contains a live attenuated (weakened) form of Aujeszky's disease virus strain NIA3-783.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W je cepivo, ki vsebuje živo, atenuirano (oslabljeno) obliko virusa Aujeszkyjeve bolezni, sev NIA3-783.
English: Other information about Suvaxyn Aujeszky 783 + O/W:
Slovenian: Druge informacije o zdravilu Suvaxyn Aujeszky 783 + O/W:
English: Suvaxyn Aujeszky 783 + O/W is a vaccine.
Slovenian: Zdravilo Suvaxyn Aujeszky 783 + O/W je cepivo.
English: What benefit has Suvaxyn Aujeszky 783 + O/W shown during the studies?
Slovenian: Kakšne koristi je zdravilo Suvaxyn Aujeszky 783 + O/W izkazalo med raziskavami?
English: What is the risk associated with Suvaxyn Aujeszky 783 + O/W?
Slovenian: Kakšna tveganja so povezana z zdravilom Suvaxyn Aujeszky 783 + O/W?
English: Why has Suvaxyn Aujeszky 783 + O/W been approved?
Slovenian: Zakaj je bilo zdravilo Suvaxyn Aujeszky 783 + O/W odobreno?
English: How has Suvaxyn Aujeszky 783 + O/W been studied?
Slovenian: Kako je bilo zdravilo Suvaxyn Aujeszky 783 + O/W raziskano?
English: What is Suvaxyn Aujeszky 783 + O/W?
Slovenian: Kaj je zdravilo Suvaxyn Aujeszky 783 + O/W?
English: What is Suvaxyn Aujeszky 783 + O/W used for?
Slovenian: Za kaj se zdravilo Suvaxyn Aujeszky 783 + O/W uporablja?
English: Pregabalin Sandoz GmbH is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Pregabalin Sandoz GmbH je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg) in se izdaja le na recept.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Slovenian: S tem se zmanjša dejavnost nekaterih živčnih celic v možganih in hrbtenjači, zaradi česar se zmanjša sproščanje drugih živčnih prenašalcev, ki so povezani epilepsijo in tesnobo.
English: The full EPAR and risk management plan summary for Pregabalin Sandoz GmbH can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pregabalin Sandoz GmbH sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.