FrancophonIA/ELRC3.0 huggingface dataset:
English: France société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
Slovenian: Francija société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
English: APOTHECON B.V. Nijverheidsweg 3 3771 ME Barneveld
Slovenian: Nijverheidsweg 3 3771 ME Barneveld
English: EUROGENERICS N.V. Heizel Esplanade b22 1020 Brussels, Belgium
Slovenian: Heizel Esplanade b22 1020 Brussels, Belgium
English: PHARMACHEMIE B.V.; Swensweg 5; Haarlem/NL, Netherlands
Slovenian: ; Swensweg 5; Haarlem/NL, Netherlands
English: SANDOZ B.V.; Veluwezoon 22; 1327 AH ALMERE/NL, Netherlands
Slovenian: ; Veluwezoon 22; 1327 AH ALMERE/NL, Netherlands
English: United Kingdom SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
Slovenian: SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
English: 15th km National Highway Athens-Lamia, Kifissia 14564, P.O.
Slovenian: 15th km National Highway Athens-Lamia, Kifissia 14564, P.O. BOX 51288, Greece
English: MERCK GENERICS B.V.; Dieselweg 26; 3752 LB Bunschoten/NL, Netherlands
Slovenian: ; Dieselweg 26; 3752 LB Bunschoten/NL, Netherlands
English: TEVA Pharma Belgium N.V. , Laarstraat 16 B-2610 Wilrijk, Belgium
Slovenian: , Laarstraat 16 B-2610 Wilrijk, Belgium
English: 1.3056 mg Tablet
Slovenian: 1.3056 mg Tableta
English: IVAX Farma b.v. Tolnasingel 3 2411 PV Bodegraven, Netherlands
Slovenian: Tolnasingel 3 2411 PV Bodegraven, Netherlands
English: 0.3275 mg Tablet
Slovenian: 0.3275 mg Tableta
English: Box 1070 251 10 Helsingborg, Sweden
Slovenian: TEVA Sweden AB, Sundstorget 2, Helsingborg P.O. Box 1070 251 10 Helsingborg, Sweden
English: 0.3264 mg Tablet
Slovenian: 0.3264 mg Tableta
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
Slovenian: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
English: Box 43011 3540 AA Utrecht, The Netherlands
Slovenian: TEVA Pharma B.V., P.O. Box 43011 3540 AA Utrecht, The Netherlands
English: United Kingdom PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
Slovenian: PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
English: 0.0655 mg Tablet
Slovenian: 0.0655 mg Tableta
English: 0.0653 mg Tablet
Slovenian: 0.0653 mg Tableta
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 50mcg tablet
Slovenian: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 50mcg tablet
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 250mcg tablet 0.25 mg
Slovenian: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Pergolide 250mcg tablet 0.25 mg
English: United Kingdom BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 250mcg tablet 0.25 mg
Slovenian: BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 250mcg tablet 0.25 mg
English: Cabergoline containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo kabergolin, z dovoljenjem za promet v Evropski uniji Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
English: United Kingdom BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 50mcg tablet
Slovenian: BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany Pergolide 50mcg tablet
English: TEVA Pharma B.V., P.O.
Slovenian: APOTHECON B.V.
English: Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
English: The CHMP noted:
Slovenian: CHMP je menil:
English: A substantial proportion of prescriptions for sinusitis in clinical practice may be empirical and without confirmation of bacterial origin.
Slovenian: Velik delež predpisanih receptov za sinuzitis v klinični praksi je lahko empiričen in brez potrditve bakterijskega izvora.
English: In 3 of these, moxifloxacin was used for treating less severe indications (sinusitis, pharyngitis and acute bronchitis).
Slovenian: Pri treh izmed teh primerov je bil moksifloksacin uporabljen za zdravljenje manj hudih indikacij (sinuzitisa, faringitisa in akutnega bronhitisa).
English: Moxifloxacin is a fluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action.
Slovenian: Moksifloksacin je fluorokinolonski antibiotik širokega spektra delovanja in protibakterijskim učinkovanjem.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORAL FORMULATIONS OF MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA PERORALNIH ZDRAVIL, KI VSEBUJEJO UČINKOVINO MOKSIFLOKSACIN (glejte Dodatek I)
English: Moxifloxacin has shown efficacy in all of the approved indications.
Slovenian: Moksifloksacin je pokazal učinkovitost pri zdravljenju vseh potrjenih indikacij.
English: In the EU, moxifloxacin is authorised in all Member States, via the Mutual Recognition or National Procedure.
Slovenian: Moksifloksacin je s postopkom medsebojnega priznavanja ali nacionalnim postopki pridobil dovoljenje za promet v vseh državah članicah Evropske unije.
English: A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/risk ratio of moxifloxacin treatment was performed.
Slovenian: Izveden je bil celovit pregled vseh reakcij jeter (hudih in manj hudih) do 30. septembra 2007 ter splošna ocena razmerja med koristmi in tveganji pri zdravljenju z moksifloksacinom.
English: Notwithstanding this fact, the safety profile of the product is of concern.
Slovenian: Kljub temu pa pri varnostnem profilu tega zdravila obstajajo zadržki.
English: Although moxifloxacin has shown to be effective, the available data is limited as studies have been mainly performed against comparators and the only placebo controlled study failed to demonstrate statistical superiority over placebo.
Slovenian: Čeprav se je moksifloksacin izkazal kot učinkovit, so razpoložljivi podatki omejeni, saj so bile študije predvsem izvedene v primerjavi z drugimi primerjalnimi zdravili, edina študija s placebo kontrolnimi skupinami pa ni uspela dokazati statistično boljših rezultatov v primerjavi s placebom.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
Slovenian: Odbor je preučil napotitev v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila s peroralnimi pripravki, ki vsebujejo moksifloksacin.
English: ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Slovenian: Akutno bakterijsko vnetje obnosnih votlin ni huda okužba in je povezana z visoko stopnjo spontanega okrevanja (90 %).
English: These findings and additional available data (observational study and clinical trials) suggested that serious liver injuries occurred more frequently with moxifloxacin then with the comparators.
Slovenian: Te ugotovitve in dodatni razpoložljivi podatki (opazovalne študije in klinični preskusi) kažejo, da se hude poškodbe jeter pojavljajo pogosteje pri zdravljenju z moksifloksacinom kot pri drugih primerjalnih zdravilih.
English: Additionally, most of the phase III studies designed for non-inferiority for moxifloxacin did not use the recommended agent of choice.
Slovenian: Poleg tega pa pri večini študij faze III, zasnovanih za enakovrednost moksifloksacina, ni bila uporabljena priporočena izbirna učinkovina.
English: However, it was noted that until recently antibiotic comparative trials in AECB designed to show equivalence between medicinal products did not demonstrate clinical superiority of any class of antibiotics over another.
Slovenian: Kljub temu pa je treba opozoriti, da do nedavnega nobene primerjalne študije v zvezi z akutno eksacerbacijo kroničnega bronhitisa, zasnovane za potrditev enakovrednosti zdravil, niso pokazale klinične superiornosti katere koli skupine antibiotikov nad drugimi.
English: In October 2007, the assessment of the 15th and 16th PSUR for moxifloxacin identified major safety concerns including life threatening hepatotoxicity cases.
Slovenian: V oktobru 2007 je potekalo ocenjevanje 15. in 16. poročila o varnosti zdravil z moksifloksacinom, ki je razkrilo velike zadržke glede varnosti uporabe moksifloksacina, vključno z življenjsko nevarnimi primeri hepatotoksičnosti.
English: Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
Slovenian: Na podlagi navedenega je Velika Britanija dne 2. junija 2008 izdala nujno opozorilo, s katerim je druge države članice, Evropsko agencijo za zdravila (EMEA) in Evropsko komisijo (EK) v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestila, da namerava spremeniti dovoljenje za promet za vse peroralne pripravke za zdravila, ki vsebujejo moksifloksacin, in sicer izbris indikacij akutnega bakterijskega vnetja obnosnih votlin, akutne eksacerbacije kroničnega bronhitisa ter omejitev indikacije za pljučnico, pridobljeno v domačem okolju.
English: Considering the higher incidence of serious and even life-threatening risks in the treatment of an infection which has a high spontaneous resolution rate without antibiotics was considered of concern.
Slovenian: Glede na visoko pojavnost resnih in celo življenjsko nevarnih tveganj pri zdravljenju okužb, za katere je značilna visoka stopnja spontanega okrevanja brez uporabe antibiotikov, je zaskrbljujoča.
English: Therefore, since the impact of the choice of an antibiotic therapy for AECB on the outcome of the patients remains unclear, the safety profile of the different antibiotherapy options must be considered.
Slovenian: Ker vpliv izbire antibiotične terapije pri zdravljenju akutne eksacerbacije kroničnega bronhitisa na bolnika ni povsem jasen, je treba preučiti varnostni profil različnih antibiotičnih terapij.
English: In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
Slovenian: V skladu z varnostnim profilom in glede na to, da je lahko akutna eksacerbacija kroničnega bronhitisa manj huda okužba, z visoko stopnjo spontanega okrevanja, pri kateri so bakterije prisotne v 50 % primerov vseh eksacerbacij, je razmerje med koristmi in tveganji pri uporabi moksifloksacina pozitivno le v primeru, kadar ni uporabljeno kot primarna izbira zdravljenja.
English: The benefit of antibiotic treatment of AECB was supported by several publications including a metaanalysis and by a recent systematic review from Cochrane Centre suggesting a mortality benefit with the use of antibiotics in this indication in comparison with placebo and a beneficial effect on lung function.
Slovenian: Korist antibiotičnega zdravljenja akutne eksacerbacije kroničnega bronhitisa je bila podprta v več publikacijah, vključno z meta analizo, in z nedavno objavljenim sistematskim poročilom centra Cochrane Centre, ki nakazuje korist glede smrtnosti pri uporabi antibiotikov za navedene indikacije v primerjavi s placebom in ugoden učinek na delovanje pljuč.
English: In view of the available data the Committee concluded that the benefit risk balance of moxifloxacin containing medicinal products in oral formulations in the approved indications under review is favourable as second line indications.
Slovenian: Na podlagi razpoložljivih podatkov je Odbor zaključil, da je razmerje med koristmi in tveganji pri uporabi zdravil s peroralnimi pripravki, ki vsebujejo moksifloksacin, pri odobrenih indikacijah, ki so predmet revizije, pozitivno pri sekundarnem indiciranju.
English: Of a total of 48 identified cases of possibly moxifloxacin-related liver disorders with a fatal outcome of any cause, 8 were suspected cases of moxifloxacin-induced fatal hepatotoxicity.
Slovenian: Skupaj je bilo ugotovljenih 48 primerov motenj delovanja jeter s smrtnim izidom, pri katerih obstaja možnost, da so povezani z uporabo moksifloksacina, za 8 primerov pa obstaja možnost, da je moksifloksacin povzročil smrtno hepatotoksičnost.
English: In the European Union (EU), Moxifloxacin film coated tablet are indicated for the treatment of acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community acquired pneumonia (CAP) except severe cases, at the dose of 400 mg daily for 7 days for ABS, 5-10 days for AECB and for 10 days for CAP.
Slovenian: V Evropski uniji (EU) so filmsko obložene tablete, ki vsebujejo moksifloksacin, indicirane za zdravljenje akutnega bakterijskega vnetja obnosnih votlin (sinuzitis, vnetje paranazalnih sinusov) (ABS), akutne eksacerbacije (nenadnega poslabšanja) kroničnega bronhitisa in pljučnice, pridobljene v domačem okolju, razen hudih oblik, z odmerkom 400 mg na dan 7 dni za zdravljenje akutnega bakterijskega vnetja obnosnih votlin, 5-10 dni za zdravljenje akutne eksacerbacije kroničnega bronhitisa in 10 dni za zdravljenje pljučnice, pridobljene v domačem okolju.
English: However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.
Slovenian: Kljub temu pa je razmerje med koristmi in tveganji uporabe moksifloksacina lahko pozitivno, kadar ni mogoče uporabiti druge terapije z antibiotiki ali pa so druge terapije neuspešne.
English: ANNEX II THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the balance of benefits and risks of oral moxifloxacin in the above indications.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je preučil vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili, o razmerju med koristmi in tveganji pri peroralnem moksifloksacinom pri zgoraj navedenih indikacijah.
English: In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity, risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.
Slovenian: Glede na razpoložljive podatke o varnosti je Odbor zaključil, da je treba smrtne primere hepatotoksičnosti in dejavnike tveganja za podaljšanje intervala QTc vključiti v navodilo za uporabo ter da je treba povečati opozorila za uporabo pri zdravljenju kolitisa, povezanega s Clostridium difficille, in buloznih kožnih reakcij.
English: The CHMP, as a consequence recommended amendments to the relevant sections of the summary of product characteristics and package leaflet for the medicinal products containing moxifloxacin (see Annex III).
Slovenian: Odbor za zdravila za uporabo v humani medicini je posledično priporočil dopolnitev ustreznih poglavij povzetka o glavnih značilnostih zdravila in navodila za uporabo za zdravila, ki vsebujejo moksifloksacin (glejte Dodatek III).
English: Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
Slovenian: Klinični preskusi in objavljeni podatki kažejo, da je moksifloksacin pri zdravljenju pljučnice, pridobljene v domačem okolju, na splošno koristen.
English: Furthermore, when taking into account other antiobiotherapy available and resistance, some times advantages over other therapies are observed in the treatment of CAP of mild to moderate severity.
Slovenian: Poleg tega se ob upoštevanju druge razpoložljive antibiotične terapije in odpornosti občasno pri zdravljenju blagih ali zmernih pljučnic, pridobljenih v domačem okolju, kažejo jasne prednosti pri uporabi moksifloksacina v primerjavi z drugimi zdravili.
English: However, considering the safety profile with observed increased incidence of risks, moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Slovenian: Vendar pa bi se moksifloksacin moral glede na varnostni profil z opaženo večjo pojavnostjo tveganja uporabljati le v primerih, kadar uporaba drugih protibakterijskih učinkovin, ki se običajno priporočajo za osnovno zdravljenje takšnih infekcij, ni ustrezna.
English: nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
Slovenian: CHMP je v skladu z zgoraj navedenim priporočil omejitev na sekundarno zdravljenje z zdravili (peroralnimi pripravki), ki vsebujejo moksifloksacin, in dodatna dopolnila navodila za uporabo, ki naj vključujejo smrtne primere hepatotoksičnosti, dejavnike tveganja za podaljšanje intervala QTc in močnejša opozorila za uporabo pri zdravljenju kolitisa, povezanega s Clostridium difficille, in buloznih kožnih reakcij.
English: Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information (PI) and under close monitoring.
Slovenian: Med najpomembnejša ugotovljena tveganja, povezana z zdravljenjem z moksifloksacinom, ki so že opisana in navedena v navodilu za uporabo ter so pozorno nadzorovana, spadajo hude oblike hepatotoksičnosti, srčna toksičnost, vključno s podaljšanim intervalom QTc (specifična nenormalnost v EKG-ju), hude kožne reakcije, kolitis (vnetje sluznice debelega črevesja), povezan s Clostridium difficile, in toksičnost kit in mišic (vključno z rabdomiolizo).
English: In ABS and AECB, moxifloxacin should only be used when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Slovenian: Pri akutnem bakterijskem vnetju obnosnih votlin in akutni eksacerbaciji kroničnega bronhitisa se moksifloksacin uporablja le, kadar je uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo pri začetnem zdravljenju teh okužb, neustrezna ali kadar ta niso uspešno pozdravila okužbe.
English: In CAP, it is to be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Slovenian: Pri pljučnici, pridobljeni v domačem okolju, se moksifloksacin uporablja le v primerih, kadar uporaba drugih protibakterijskih učinkovin, ki se običajno priporočajo za začetno zdravljenje takšnih okužb, ni ustrezna.
English: Alternates (and other participants)
Slovenian: Nadomestni člani (in drugi udeleženci)
English: • Letter from the president of the European Parliament.
Slovenian: • Dopis predsednika Evropskega parlamenta.
English: Substances of human origin (SoHO)
Slovenian: Snovi človeškega izvora (SoHo)
English: • parental and family leave.
Slovenian: • starševski in družinski dopust.
English: Olympics 2012
Slovenian: Olimpijske igre leta 2012
English: These are addressed in the Memorandum of Understanding that has been signed by all Member States.
Slovenian: Ti so zajeti v memorandumu o soglasju, ki so ga podpisale vse države članice.
English: • Revised draft Agenda version 4.0.
Slovenian: • Revidirani osnutek dnevnega reda, različica 4.0.
English: The revenue is in line with the forecast, while expenditure is lower than planned.
Slovenian: Prihodki so v skladu z napovedmi, odhodki pa so nižji od načrtovanih.
English: Operational excellence programme - OpEx
Slovenian: Program operativne odličnosti - OpEx
English: The current practice has been to adopt decisions by consensus.
Slovenian: Sedanja praksa je bila sprejemanje odločitev s soglasjem.
English: More video-conferencing will be held during the Olympic period.
Slovenian: V času olimpijskih iger bo potekalo več videokonferenc.
English: The policy for experts was implemented on 29 September 2011, with declarations of experts published on 30 September.
Slovenian: Politika za strokovnjake se je začela izvajati 29. septembra 2011, izjave strokovnjakov pa so bile objavljene 30. septembra.
English: • part-time working scheme;
Slovenian: • delo s krajšim delovnim časom;
English: The date of the visit is to be confirmed.
Slovenian: Datum obiska še ni potrjen.
English: Visit by the delegation of the European Parliament Committee on Environment, Public Health and Food Safety
Slovenian: Obisk delegacije Odbora Evropskega parlamenta za okolje, javno zdravje in varnost hrane
English: The draft staff rules on conflicts of interests were adopted in June and the implementation started immediately.
Slovenian: Osnutek pravilnika o navzkrižjih interesov za osebje je bil sprejet junija, izvajanje pa se je začelo takoj.
English: The policy does not cover staff and experts working in national competent authorities.
Slovenian: Politika ne vključuje osebja in strokovnjakov, ki so zaposleni pri nacionalnih pristojnih organih.
English: The need for a bridging budget for EMA is being discussed).
Slovenian: Razpravlja se o potrebi po premostitvenem proračunu agencije EMA).
English: A number of national authorities, including those from Sweden, Germany, Malta and the Netherlands, have agreed to host such meetings.
Slovenian: Številni nacionalni organi, vključno z organi iz Švedske, Nemčije, Malte in Nizozemske, so se strinjali, da bodo gostili takšne seje.
English: • The Innovation Partnership on Active and Healthy Ageing (first areas of work have been identified).
Slovenian: • partnerstvo za inovacije za aktivno in zdravo staranje (opredeljena so bila prva področja delovanja);
English: Discharge for the budget year 2009
Slovenian: Razrešnica za proračunsko leto 2009
English: Guido Rasi will take office on 16 November 2011.
Slovenian: Guido Rasi bo nastopil mandat 16. novembra 2011.
English: The Agency will move to the new premises following the expiry of the current lease in 2014.
Slovenian: Agencija se bo v nove prostore preselila po izteku sedanje najemne pogodbe v letu 2014.
English: The next report will be prepared in 2013.
Slovenian: Naslednje poročilo bo pripravljeno leta 2013.
English: The Board thanked the Agency, the national authorities and colleagues who were directly responsible for putting in place this very successful initiative.
Slovenian: Odbor se je zahvalil agenciji, nacionalnim organom in sodelavcem, ki so bili neposredno odgovorni za vzpostavitev te zelo uspešne pobude.
English: 23 November 2011
Slovenian: 23. novembra 2011
English: • The revised proposal on information to patients is expected to be adopted on 11 October 2011.
Slovenian: • spremenjen predlog o informacijah za bolnike bo po pričakovanjih sprejet 11. oktobra 2011;
English: Members noted the report from the Chair about significant differences as to how responsibilities for substances of human origin are allocated at the level of Member States.
Slovenian: Člani so se seznanili s poročilom predsednika o znatnih razlikah glede tega, kako se odgovornosti za snovi človeškega izvora dodeljujejo na ravni držav članic.
English: It was suggested to have a closer look at minor species in future.
Slovenian: Predlagano je bilo, da je treba v prihodnosti več pozornosti posveti manj pomembnim vrstam.