FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the concerns above and in line with the aforementioned recommendations from the EMA/CVMP/CHMP scientific advice to the European Commission, as a second step, the Committee was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Slovenian: Glede na zgornje pomisleke in skladno z omenjenimi priporočili znanstvenega mnenja EMA/CVMP/CHMP za Evropsko komisijo je bil odbor v drugem koraku pozvan, naj pregleda dovoljenja za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje vrstam za proizvodnjo živil, da se zagotovi odgovorna uporaba sredstva pri varovanju zdravja živali in omejevanju možnosti prihodnjega tveganja za javno zdravje.
English: Current European Committee on Antimicrobial Susceptibility Testing clinical breakpoints for Enterobacteriaceae are under revision because of these issues.
Slovenian: Zaradi teh vprašanj se revidirajo trenutne klinične mejne vrednosti Evropskega odbora za testiranje protimikrobne občutljivosti za bakterije družine Enterobacteriaceae.
English: Having considered all data submitted in writing, the CVMP concluded that the benefit-risk balance for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Slovenian: Ob upoštevanju vseh podatkov, predloženih v pisni obliki, je odbor CVMP zaključil, da je razmerje med tveganji in koristmi za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje vrstam za proizvodnjo živil, negativno, in sicer zaradi pomanjkanja kliničnega pomena in zaradi čezmerne izpostavljenosti kolistinu, ki bi lahko pomenila potencialno tveganje za zdravje živali in ljudi zaradi pospešenega pojava odpornosti proti kolistinu.
English: No specific clinical studies were provided for invasive E. coli secondary to gastrointestinal disease.
Slovenian: Za invazivno E. coli, ki je posledica bolezni prebavil, niso bile predložene posebne klinične študije.
English: Veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species represent commonly used antimicrobials in veterinary medicine.
Slovenian: Zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje vrstam za proizvodnjo živil so pogosto uporabljena protimikrobna sredstva v veterinarski medicini.
English: Fatro S.p.A Via Emilia Nº 285 Ozzano Emilia Italy
Slovenian: Portugalska Fatro S.p.A Via Emilia Nº 285
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf as described in the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Slovenian: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf ne prispeva k skupni terapevtski učinkovitosti za te indikacije.
English: The same conclusion was reached in the recent Article 35 referral procedure on oral colistin monotherapy products.
Slovenian: Do enakega zaključka so prišli v nedavnem napotitvenem postopku v skladu s členom 35 za peroralna zdravila za monoterapijo s kolistinom.
English: The broad-spectrum activity of colistin against Gram-negative bacteria involves binding to lipid A, the anchor for lipopolysaccharide and the main constituent of the outer membrane of many bacteria
Slovenian: Širokospektralna aktivnost kolistina proti po Gramu negativnim bakterijam vključuje vezavo na lipid A, ki je pritrdišče za lipopolisaharid in glavna sestavina zunanje membrane številnih bakterij
English: Grounds for withdrawal of the marketing authorisations
Slovenian: Podlaga za umik dovoljenj za promet z zdravilom
English: No proprietary data or valid justifications could be provided in support of prevention and prophylaxis claims.
Slovenian: V podporo trditvam o preprečevanju in profilaksi niso na voljo zaščiteni podatki ali veljavne utemeljitve.
English: In this procedure the CVMP was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Slovenian: V tem postopku je bil odbor CVMP naprošen, naj pregleda dovoljenja za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje vrstam za proizvodnjo živil, da se zagotovi odgovorna uporaba sredstva pri varovanju zdravja živali in omejevanju možnosti prihodnjega tveganja za javno zdravje.
English: Thus, colistin has re-emerged as a last-resort therapeutic option to treat infections due to MDR, XDR and PDR, lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii.
Slovenian: Zato je kolistin ponovno postal zadnja terapevtska možnost za zdravljenje okužb, ki jih povzročajo bakaterije MDR, XDR in PDR, laktozo fermentirajoči in nefermentirajoči po Gramu negativni bacili, vključno s Pseudomonas aeruginosa in Acinetobacter baumannii.
English: Pigs, chickens (except hens producing eggs for human consumption)
Slovenian: predmešanica za zdravilno krmno mešanico prašiči, piščanci (razen kokoši, katerih jajca so namenjena za prehrano ljudi)
English: Polymyxins have no clinically useful activity against Gram-positive bacteria, Gram-negative cocci, anaerobes and Mollicutes including Mycoplasma spp.
Slovenian: Polimiksini nimajo klinično uporabne aktivnosti proti po Gramu pozitivnim bakterijam, po Gramu negativnim kokom, anaerobom in molikutom, vključno z mikroorganizmi rodu Mycoplasma
English: Colamox 3200/640 Amoxicillin trihydrate Colistin sulphate
Slovenian: Colamox 3200/640 amoksicilinijev trihidrat kolistinijev sulfat
English: For food-producing animals in the EU/EEA today, field studies have shown that it is used primarily for pigs including group treatments and prevention of diarrhoea caused by E. coli and Salmonella spp., as first-choice http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
Slovenian: 9 in http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
English: Also, the clinical relevance of synergy with colistin combinations is highly doubtful for the reason that colonic concentrations of colistin alone are so much higher than the MIC (e.g. 20 times more than the MIC) for E. coli and other bacteria, as a monotherapy, hence there is no clinical added value for an in vitro synergy of colistin combinations.
Slovenian: dvomljiv, saj so koncentracije kolistina samega v debelem črevesu bistveno višje kot MIK (npr. 20-krat višje kot MIK) za E. coli in druge bakterije pri monoterapiji, zato ni klinične dodane vrednosti kombinacij s kolistinom za sinergijo in vitro.
English: Also, no proprietary data or valid justifications could be provided in support of Salmonella spp.
Slovenian: Prav tako niso na voljo zaščiteni podatki ali veljavne utemeljitve v podporo indikacijam za vrste rodu Salmonella.
English: For example, the current status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs to colistin are very low and colistin colonic concentrations are very high (e.g. 20 times more than the MIC) such that a monotherapy product could suffice for these indications.
Slovenian: Trenutni status za zadevne po Gramu negativne gastrointestinalne povzročitelje (npr. E. coli) v EU je na primer tak, da so MIK za kolistin zelo nizke, koncentracije kolistina v debelem črevesu pa zelo visoke (npr. 20-krat višje od MIK), tako da bi pri teh indikacijah zadoščala monoterapija.
English: Therefore, the CVMP recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Slovenian: Zato je odbor CVMP priporočil umik dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje.
English: During a routine surveillance project on antimicrobial resistance in commensal E. coli from food animals in China, polymyxin resistance was shown to be singularly due to the plasmid-mediated mcr-1 gene Furthermore, this mcr-1 carriage in E. coli isolates was also found in 78 (15%) of 523 samples of raw meat products and 166 (21%) of 804 animals sampled during 2011-14.
Slovenian: E. coli našli tudi pri 78 (15 %) od 523 vzorcev surovih mesnih izdelkov in 166 (21 %) od 804 živali, vzorčenih v obdobju od leta 2011 do leta 2014.
English: Currently the status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs of colistin are very low and colistin colonic concentrations are very high (e.g. 20 times above the MIC) such that a monotherapy product will suffice for these indications.
Slovenian: Trenutni status za zadevne po Gramu negativne gastrointestinalne povzročitelje (npr. E. coli) v EU je tak, da so MIK za kolistin zelo nizke, koncentracije kolistina v debelem črevesu pa zelo visoke (npr. 20-krat višje od MIK), tako da pri teh indikacijah zadošča monoterapija.
English: Colistin combination products are seen to serve a role for these more complex production-related diseases and clinical studies are available for some combinations, which demonstrated efficacy for some conditions.
Slovenian: Za nekatere kombinacije so na voljo tudi klinične študije, v katerih so dokazali učinkovitost pri nekaterih stanjih.
English: However, no benefit could be demonstrated of using colistin combination products over monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even a limited use of colistin combination products was considered an unnecessary use of colistin.
Slovenian: Prav tako ni bilo mogoče opredeliti izvedljivih ukrepov za zmanjšanje tveganja, s katerimi bi obravnavali ugotovljeno potencialno tveganje za zdravje ljudi, saj je celo omejena uporaba kombiniranih zdravil s kolistinom obveljala za nepotrebno uporabo kolistina.
English: For gastrointestinal indications, there are also concerns if colistin combinations products are necessary over monotherapy.
Slovenian: Tudi za gastrointestinalne indikacije obstajajo pomisleki, ali imajo kombinirana zdravila s kolistinom prednost pred monoterapijo.
English: the CVMP has recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally as referred in Annex I.
Slovenian: odbor CVMP je priporočil umik dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje iz Priloge I.
English: Justification of colistin combination products
Slovenian: Utemeljitev kombiniranih zdravil s kolistinom
English: NEOMIX COMPLEX Neomycin sulfate Colistin sulphate
Slovenian: NEOMIX COMPLEX neomicinijev sulfat kolistinijev sulfat
English: Netherlands Dopharma B.V. Zalmweg 24
Slovenian: Nizozemska Dopharma B.V.
English: Rhone Vet Kft.
Slovenian: Madžarska Rhone Vet Kft. Petőfi u. 9.
English: Colistin sulphate mg/tablet mg/tablet
Slovenian: oksitetraciklinijev klorid kolistinijev sulfat mg/tablet mg/tablet tablete perutnina (divje kokoši in vodna perutnina)
English: For non-gastrointestinal indications there are concerns of lack of justification for colistin combination products.
Slovenian: Pri negastrointestinalnih indikacijah obstaja pomislek, da uporaba kombiniranih zdravil s kolistinom ni utemeljena.
English: Historically, this instability of polymyxin resistance, and the absence of horizontal gene transfer of these mutations, was thought to reduce the risk of rapid spread of resistance to colistin
Slovenian: preteklosti so menili, da ta nestabilnost odpornosti proti polimiksinom in odsotnost horizontalnega prenosa genov s temi mutacijami zmanjšujeta tveganje za hitro širjenje odpornosti proti kolistinu Vendar je pomembno omeniti, da stabilna odpornost na subklinični ravni (heterorezistenca) s klasičnimi tehnikami gojenja/določanja občutljivosti lahko ostane neodkrita
English: Combinations of colistin with other antimicrobials are available for group treatments of gastrointestinal and respiratory infections in food-producing animals in some European Member States.
Slovenian: V nekaterih evropskih državah članicah so za skupinsko zdravljenje okužb prebavil in dihal pri živalih za proizvodnjo živil na voljo kombinacije kolistina z drugimi protimikrobnimi sredstvi.
English: Murgašova 5 949 01 Nitra Slovakia
Slovenian: 949 01 Nitra
English: 2 on sales of
Slovenian: 2 o prodaji protimikrobnih sredstev,
English: Oral administration individually
Slovenian: posamično peroralno dajanje
English: 1 g/tablet 1 MIU/ tablet
Slovenian: 1 g/tablet 1 MIU/ tablet tableta teleta peroralna uporaba
English: VETLIMA-Sociedade Distribuidora de Produtos AgroPecuários, S.A.
Slovenian: Portugalska VETLIMA-Sociedade Distribuidora de
English: Polymicrobial gastrointestinal infections were not identified by the MAHs for the animal species and indications listed for their products.
Slovenian: Imetniki dovoljenj za promet z zdravilom pri živalskih vrstah in indikacijah, navedenih za njihova zdravila, niso identificirali polimikrobnih okužb prebavil.
English: In vitro antimicrobial synergy was identified by several MAHs and backed up by scientific publications, based on both a reduction of the MIC for target pathogens in the presence of the colistin combination and a reduction in the fractional inhibitory concentration index.
Slovenian: Več imetnikov dovoljenj za promet z zdravilom je na podlagi zmanjšanja MIK za tarčne povzročitelje v prisotnosti kombinacije s kolistinom in zmanjšanja indeksa frakcijske inhibitorne koncentracije prepoznalo protimikrobno sinergijo in vitro, kar je podprto tudi v znanstvenih objavah.
English: In drinking water use
Slovenian: peroralno dajanje v vodo za pitje
English: Based on the information provided by MAHs, including proprietary data, scientific references and expert reports, a possible risk mitigation measure considered in this Article 35 referral was to further limit the use of colistin combination products to treatment of individual animals only and remove presentations of products intended for group treatment.
Slovenian: tveganja, obravnavan v tej napotitvi v skladu s členom 35, dodatna omejitev uporabe kombiniranih zdravil s kolistinom na zdravljenje samo posameznih živali in odstranitev oblik zdravil, namenjenih za skupinsko zdravljenje.
English: “However, severe nosocomial infections due to multidrug-resistant (MDR) Gram-negative bacteria now account for high morbidity and mortality in man. Colistin is therefore nowadays a last resort drug in human medicine in the context of treatment of infections caused by MDR Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), for which mortality can be extremely high.”
Slovenian: Kolistin je torej danes v humani medicini zadnja možnost pri zdravljenju okužb, ki jih povzročajo MDR Pseudomonas aeruginosa, Acinetobacter baumanii in Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), pri katerih je umrljivost izjemno visoka.“
English: Via Piana 265 47032 Bertinoro Italy
Slovenian: 47032 Bertinoro Italy
English: BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku
Slovenian: BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku kolistinijev sulfat spiramicinijev adipat
English: Via Emilia, 285 40064 Ozzano Emilia Italy
Slovenian: 40064 Ozzano Emilia Italy
English: In addition, the MAHs were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Slovenian: Poleg tega so bili imetniki dovoljenj za promet z zdravilom pozvani, naj utemeljijo prednosti uporabe kombiniranih zdravil s kolistinom pred uporabo monoterapije pri zdravljenju ustreznih stanj, zlasti z upoštevanjem smernice CVMP o farmacevtskih proizvodih s fiksno kombinacijo
English: Pigs, calves Oral use
Slovenian: MIU/g prašek za peroralno uporabo prašiči, teleta peroralna uporaba
English: Dopharma B.V. Zalmweg 24
Slovenian: Dopharma B.V.
English: Колитетравит / COLI - TETRAVIT
Slovenian: Колитетравит / COLITETRAVIT
English: Oral solution Chickens and pigs
Slovenian: peroralna raztopina piščanci in prašiči peroralno dajanje
English: NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros
Slovenian: NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros ampicilinijev trihidrat kolistinijev sulfat
English: 2.5 MIU/ tablet 1 g/tablet
Slovenian: 2.5 MIU/ tablet 1 g/tablet tableta jagnjeta, koze, teleta peroralna uporaba
English: Trimethoprim Colistin sulphate
Slovenian: trimetoprim kolistinijev sulfat
English: 640 mg/g
Slovenian: 640 mg/ml
English: Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.
Slovenian: 11.48 g 4.00 g predmešanica za zdravilno krmno mešanico prašiči predmešanica za zdravilno krmno mešanico v obliki netopnega praška, ki se daje peroralno, primerno zmešana s trdno krmo
English: Ampicillin trihydrate Colistin sulphate
Slovenian: ampicilinijev trihidrat kolistinijev sulfat
English: The same applies for Salmonella spp.
Slovenian: Enako velja za indikacije za vrste rodu Salmonella pri kombiniranih zdravilih s kolistinom.
English: BELCOSPIRA ORAL Colistin sulphate
Slovenian: BELCOSPIRA ORAL
English: treatment for neonatal diarrhoea caused by E. coli in piglets 9 and veal calves as well as for the therapy of mild colibacillosis in poultry
Slovenian: coli in bakterije iz rodu Salmonella, kot zdravljenje prve izbire za neonatalno drisko, ki jo povzroča E. coli pri prašičkih
English: DIVASA FARMAVIC DE PORTUGAL Produtos e Equipamentos Veterinários, Lda.
Slovenian: Portugalska DIVASA FARMAVIC DE PORTUGAL
English: Oral powder for use in drinking water or liquid feed
Slovenian: prašek za peroralno raztopino za dajanje z vodo za pitje teleta in jagnjeta peroralno
English: This is for the reason that colistin is not absorbed from the gastrointestinal tract after oral administration and thus does not contribute to the overall therapeutic efficacy for these indications.
Slovenian: Razlog je ta, da se kolistin po peroralni uporabi ne absorbira iz prebavnega trakta in tako
English: Oxytetracycline hydrochloride Colistin sulphate
Slovenian: oksitetraciklinijev klorid kolistinijev sulfat
English: Enrofloxacin Colistin sulphate
Slovenian: enrofloksacin kolistinijev sulfat
English: Colistin sulphate Erythromycin estolate
Slovenian: eritromicinijev estolat kolistinijev sulfat
English: Sulfamethoxypyridazine
Slovenian: kolistinijev sulfat sulfametoksipiridazin
English: Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)
Slovenian: prašek za peroralno raztopino teleta, ovce, koze, prašiči, žrebeta, piščanci, purani (razen nesnic)
English: Calves, lambs, kids, piglets, poultry and rabbits
Slovenian: peroralni prašek teleta, jagnjeta, kozlički, prašički, perutnina in kunci peroralno
English: due to a negative benefit-risk assessment.
Slovenian: Ocena razmerja med tveganji in koristmi
English: Colistin sulphate Spiramycin adipate
Slovenian: kolistinijev sulfat sulfagvanidin
English: AMOXY-COL WSP Amoxicillin trihydrate Colistin sulphate
Slovenian: AMOXYCOL, geriamieji milteliai amoksicilinijev trihidrat kolistinijev sulfat
English: COLISULTRIX, geriamieji milteliai
Slovenian: COLISULTRIX, geriamieji milteliai trimetoprim kolistinijev sulfat
English: Colistin sulphate
Slovenian: kolistinijev sulfat sulfadimetoksin
English: Oral powder, for use in drinking water or liquid feed
Slovenian: 200 mg/g peroralni prašek za dajanje v vodo za pitje ali tekočo krmo teleta, prašički, brojlerji in purani peroralno
English: Pigs, chickens In drinking water use
Slovenian: 640 mg/g prašek za peroralno raztopino prašiči, piščanci peroralno dajanje v vodo za pitje
English: UI/ml solución para administración en agua de bebida
Slovenian: COLIPHUR 100 000/1 200 000 UI/ml solución para administración en agua de bebida neomicinijev sulfat kolistinijev sulfat
English: Chlortetracycline hydrochloride Colistin sulphate
Slovenian: TETRAKOL prášok na perorálny roztok klortetraciklinijev klorid kolistinijev sulfat
English: Chickens, rabbits, pigs, calves and lambs
Slovenian: peroralni prašek piščanci, kunci, prašiči, teleta in jagnjeta peroralno dajanje
English: Calves, piglets, foals, chicken
Slovenian: prašek za peroralno raztopino teleta, prašički, žrebeta, piščanci peroralno
English: Doxycycline hyclate Colistin sulphate
Slovenian: doksiciklinijev hiklat kolistinijev sulfat
English: COLIPHUR 100
Slovenian: ENTEROGEL 30
English: Romania Industria Italiana Integratori Trei
Slovenian: Romunija Industria Italiana Integratori Trei S.p.A Viale Corassori, 62
English: MICROAMOX COLI Amoxicillin trihydrate Colistin sulphate
Slovenian: COLISULTRIX POUDRE kolistinijev sulfat trimetoprim
English: 2 MIU/ tablet 1 g/tablet
Slovenian: 2 MIU/ tablet 1 g/tablet tableta jagnjeta, psi, žrebeta, teleta peroralna uporaba
English: Vetoquinol Italia S.R.L
Slovenian: Vetoquinol Italia S.R.L Via Piana, 265
English: Oxytetracycline hydrochloride
Slovenian: kolistinijev sulfat oksitetraciklinijev klorid
English: MIU/tablet 1 g/tablet
Slovenian: MIU/tablet 1 g/tablet tableta jagnjeta, psi, žrebeta, teleta peroralna uporaba
English: Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat
Slovenian: MIU/100 g prašek za peroralno raztopino govedo (teleta), ovce (jagnjeta), prašiči in piščanci, kunci, koze dajanje v vodo za pitje
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Slovenian: Odbor CHMP je obravnaval vlogo in meni, da je razmerje med tveganji in koristmi ugodno za priporočilo za odobritev pogojnega dovoljenja za promet z zdravilom, kot je dodatno pojasnjeno v Evropskem javnem poročilu o oceni zdravila.