FrancophonIA/ELRC3.0 huggingface dataset:
English: While you are taking Clopidogrel/Acetylsalicylic acid Zentiva:
Slovenian: Ko jemljete zdravilo Klopidogrel/acetilsalicilna kislina Zentiva:
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172) - Polishing agent: carnauba wax
Slovenian: Pomožne snovi so: - Jedro tablete: manitol (E421), makrogol 6000, mikrokristalna celuloza, nizko substituirana hidroksipropilceluloza, koruzni škrob, hidrogenirano ricinusovo olje (glejte poglavje 2 ‘Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva vsebuje hidrogenirano ricinusovo olje'), stearinska kislina in brezvodni koloidni silicijev dioksid.
English: Other medicinal products
Slovenian: FARMACEVTSKI PODATKI
English: Patients should also be told that it might take longer than usual to stop bleeding when they take Clopidogrel/Acetylsalicylic acid Zentiva, and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Bolnikom morate povedati, da se jim lahko med jemanjem zdravila Klopidogrel/acetilsalicilna kislina Zentiva krvavitve ustavijo počasneje kot ponavadi.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva should be given as a single daily 75 mg/75 mg dose.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se mora dajati kot enkratni dnevni odmerek 75 mg/75 mg.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva should be given as a single daily 75 mg/100 mg dose.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se mora dajati kot enkratni dnevni odmerek 75 mg/100 mg.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (kot hidrogensulfata) in 100 mg acetilsalicilne kisline (ASA).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (kot hidrogensulfata) in 75 mg acetilsalicilne kisline (ASA).
English: If you stop taking Clopidogrel/Acetylsalicylic acid Zentiva Do not stop the treatment unless your doctor tells you so.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva morate jemati toliko časa, kot vam je naročil zdravnik.
English: How to store Clopidogrel/Acetylsalicylic acid Zentiva
Slovenian: Shranjevanje zdravila Klopidogrel/acetilsalicilna kislina Zentiva
English: EU/1/10/623/008 14 film-coated tablets EU/1/10/623/009 28 film-coated tablets EU/1/10/623/010 30x1 film-coated tablet EU/1/10/623/011 50x1 film-coated tablet EU/1/10/623/012 84 film-coated tablets EU/1/10/623/013 90x1 film-coated tablet EU/1/10/623/014 100x1 film-coated tablet
Slovenian: EU/1/10/623/008 14 filmsko obloženih tablet EU/1/10/623/009 28 filmsko obloženih tablet EU/1/10/623/010 30 x 1 filmsko obloženih tablet EU/1/10/623/011 50 x 1 filmsko obloženih tablet EU/1/10/623/012 84 filmsko obloženih tablet EU/1/10/623/013 90 x 1 filmsko obloženih tablet EU/1/10/623/014 100 x 1 filmsko obloženih tablet
English: EU/1/10/623/001 14 film-coated tablets EU/1/10/623/002 28 film-coated tablets EU/1/10/623/003 30x1 film-coated tablet EU/1/10/623/004 50x1 film-coated tablet EU/1/10/623/005 84 film-coated tablets EU/1/10/623/006 90x1 film-coated tablet EU/1/10/623/007 100x1 film-coated tablet EU/1/10/623/015 30 film-coated tablets
Slovenian: EU/1/10/623/001 14 filmsko obloženih tablet EU/1/10/623/002 28 filmsko obloženih tablet EU/1/10/623/003 30 x 1 filmsko obloženih tablet EU/1/10/623/004 50 x 1 filmsko obloženih tablet EU/1/10/623/005 84 filmsko obloženih tablet EU/1/10/623/006 90 x 1 filmsko obloženih tablet EU/1/10/623/007 100 x 1 filmsko obloženih tablet EU/1/10/623/015 30 filmsko obloženih tablet
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets EU/1/10/623/001 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/623/002 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/623/003 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/623/004 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/623/005 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/623/006 - Cartons of 90x1film-coated tablet in aluminium blister packs EU/1/10/623/007 - Cartons of 100x1film-coated tablet in aluminium blister packs EU/1/10/623/015 - Cartons of 30 film-coated tablet in aluminium blister packs
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete EU/1/10/623/001 - Škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/002 - Škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/003 - Škatle s 30 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/004 - Škatle s 50 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/005 - Škatle s 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/006 - Škatle z 90 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/007 - Škatle s 100 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/015 - Škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow, engraved on one side with ‘C75' and ‘A75'on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete (tablete) so ovalne, rahlo bikonveksne, rumene, z vtisnjeno oznako «C75» na eni strani in «A75» na drugi strani.
English: If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets The active substances are clopidogrel and acetylsalicylic acid (ASA).
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Zdravilni učinkovini sta klopidogrel in acetilsalicilna kislina (ASA).
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Red iron oxide (E172)
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) triacetin (E1518) rdeči železov oksid (E172)
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75' and ‘A100'on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete (tablete) so ovalne, rahlo bikonveksne, svetlo rožnate, z vtisnjeno oznako «C75» na eni strani in «A100» na drugi strani.
English: Do not take Clopidogrel/Acetylsalicylic acid Zentiva
Slovenian: Ne jemljite zdravila Klopidogrel/acetilsalicilna kislina Zentiva:
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg
English: The safety of the concomitant administration of Clopidogrel/Acetylsalicylic acid Zentiva with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Slovenian: Varnost sočasne uporabe zdravila Klopidogrel/acetilsalicilna kislina Zentiva z drugimi trombolitiki ni formalno ugotovljena.
English: In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Slovenian: Študije in vitro so pokazale, da se izpostavljenost repaglinidu poveča zaradi zavrtja
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Light pink, oval, slightly biconvex, engraved with «C75» on one side and «A100» on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Svetlo rožnata, ovalna, rahlo bikonveksna, z vtisnjeno oznako "C75" na eni strani in "A100" na drugi strani.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete
English: What Clopidogrel/Acetylsalicylic acid Zentiva contains
Slovenian: Kaj vsebuje zdravilo Klopidogrel/acetilsalicilna kislina Zentiva
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Yellow, oval, slightly biconvex, engraved with «C75» on one side and «A75» on the other side.
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Rumena, ovalna, rahlo bikonveksna, z vtisnjeno oznako "C75" na eni strani in "A75" na drugi strani.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Yellow iron oxide (E172)
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) triacetin (E1518) rumeni železov oksid (E172)
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/Acetylsalicylic acid Zentiva contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) - Polishing agent: carnauba wax
Slovenian: - Obloga tablete: laktoza monohidrat (glejte poglavje 2 ‘Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva vsebuje laktozo'), hipromeloza (E464), titanov dioksid (E171), triacetin (E1518) in rumeni železov oksid (E172) - Polirno sredstvo: karnauba vosek.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Navodilo za uporabo Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete klopidogrel in acetilsalicilna kislina
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets EU/1/10/623/008 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/623/009 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/623/010 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/623/011 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/623/012 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/623/013 - Cartons of 90x1 film-coated tablet in aluminium blister packs EU/1/10/623/014 - Cartons of 100x1 film-coated tablet in aluminium blister packs
Slovenian: EU/1/10/623/008 - Škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/009 - Škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/010 - Škatle s 30 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/011 - Škatle s 50 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/012 - Škatle s 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/623/013 - Škatle z 90 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/623/014 - Škatle s 100 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASArelated GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Slovenian: Krvavitev v prebavila in retroperitonealna krvavitev (opisani so primeri s smrtnim izidom), pankreatitis, bolezni zgornjih prebavil (ezophagitis (vnetje sluznice požiralnika), ulkus požiralnika (razjede v požiralniku), perforacija (predrtje), erozivni gastritis, erozivni duodenitis; razjede/perforacije na želodcu/dvanajstniku)*, bolezni spodnjih prebavil (ulkusi (peptične razjede) tankega [jejunum in ileum] in debelega črevesa [kolon in
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete
English: You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Zentiva.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel/acetilsalicilna kislina Zentiva
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg tablete klopidogrel/acetilsalicilna kislina
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg tablete klopidogrel/acetilsalicilna kislina
English: Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva vsebuje hidrogenirano ricinusovo olje.
English: Therapeutic experience is limited in patients with mild to moderate renal impairment (see section 4.4).
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se ne sme uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavje 4.3).Terapevtskih izkušenj pri bolnikih z blago do zmerno okvaro ledvic je malo (glejte poglavje 4.4).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete klopidogrel / acetilsalicilna kislina
English: 28 March 2019
Slovenian: 28. marca 2019
English: It began operating in 1995.
Slovenian: Delovati je začela leta 1995.
English: The revised policy entered into force on 30 January 2015.
Slovenian: Nova, spremenjena politika je začela veljati 30. januarja 2015.
English: Annual review of policies on independence
Slovenian: Letni pregled politik o neodvisnosti
English: The Agency has separate policies in place for these groups.
Slovenian: Za te skupine je sprejela ločene politike.
English: Each EU Member State has its own national authorisation procedures.
Slovenian: Vsaka država članica EU ima svoje nacionalne postopke izdaje dovoljenj.
English: This supports an exchange of information on a number of issues, including:
Slovenian: S tem se podpira izmenjava informacij o številnih vprašanjih, vključno z:
English: EMA subsequently updated the policy:
Slovenian: Agencija EMA je pozneje politiko posodobila:
English: • the Innovation Task Force, a forum for early dialogue with applicants.
Slovenian: • projektna skupina za inovacije, forum za zgodnji dialog s predlagatelji.
English: Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
Slovenian: Omejitve vključevanja se sčasoma zmanjšujejo, pri čemer obstaja razlika med trenutnimi interesi in interesi v zadnjih treh letih;
English: • for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.
Slovenian: • za nekatere interese, kot so finančni, se še naprej ne zahteva obdobje mirovanja, če interes ne obstaja več.
English: • whose authorisation would be in the interest of public or animal health at EU level.
Slovenian: • katerih odobritev bi bila v interesu javnega zdravja ali zdravja živali na ravni EU.
English: All other DoIs are available on request.
Slovenian: Vse druge izjave o interesih so na voljo na zahtevo.
English: New staff must get rid of any interests they have before they can start to work at the Agency.
Slovenian: Novo zaposlene osebe se morajo odpovedati vsem interesom, ki jih imajo, preden lahko začnejo delati pri agenciji.
English: The centralised procedure is compulsory for:
Slovenian: Centralizirani postopek je obvezen za:
English: • Accelerates the exchange of information on important issues, such as the safety of medicines.
Slovenian: • Pospešuje izmenjavo informacij o pomembnih vprašanjih, kakršno je varnost zdravil.
English: Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.
Slovenian: Podobno so zahteve za predsednike in člane z vodilno vlogo, npr. poročevalce, strožje od zahtev za druge člane odborov.
English: The system for regulating medicines in Europe is unique in the world.
Slovenian: Sistem zakonske ureditve zdravil v Evropi je edinstven na svetu.
English: Experts can only be involved once the Agency has assessed their declaration of interests.
Slovenian: Strokovnjaki se lahko vključijo šele po tem, ko je agencija ocenila njihovo izjavo o interesih.
English: Board members are appointed for a three-year term, which may be renewed.
Slovenian: Člani upravnega odbora se imenujejo za triletno obdobje, ki se lahko podaljša.
English: • support for early access;
Slovenian: • podpora za zgodnji dostop;
English: Provide information to healthcare professionals and patients
Slovenian: Zagotavljanje informacij zdravstvenim delavcem in bolnikom
English: EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Slovenian: Agencija EMA je decentralizirana agencija Evropske unije (EU) s sedežem v Amsterdamu.
English: • for the majority of declared interests a three-year cooling-off period is foreseen.
Slovenian: • za večino prijavljenih interesov je predvideno triletno obdobje mirovanja.
English: For more information, see Section 3.1.
Slovenian: Več informacij je na voljo v razdelku 3.1.
English: • developing guidelines and setting standards;
Slovenian: • razvija smernice in določa standarde;
English: The report includes results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.
Slovenian: Poročilo vsebuje rezultate postopkov za obravnavo zlorabe zaupanja, vsa opravljena preverjanja, pobude, načrtovane za naslednje leto, in priporočila za izboljšave.
English: • the type of activity that the expert will be undertaking.
Slovenian: • vrsti dejavnosti, ki jo bo izvajal strokovnjak.
English: The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.
Slovenian: Za doseganje teh ciljev uporablja različne regulativne mehanizme, ki jih nenehno pregleduje in izboljšuje.
English: • the time since the interest occurred;
Slovenian: • času, ki je pretekel, odkar se je pojavil interes;
English: The Agency publishes clear and impartial information about medicines and their approved uses.
Slovenian: Agencija objavlja jasne in nepristranske informacije o zdravilih in njihovih odobrenih uporabah.
English: The Management Board is made up of the following members:
Slovenian: Upravni odbor ima naslednje člane:
English: The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Slovenian: Upravni odbor sestavlja 35 članov, ki se imenujejo za delovanje v javnem interesu ter ne zastopajo vlad, organizacij ali sektorja.
English: EMA strives towards being as open and transparent as possible about how it reaches its scientific conclusions.
Slovenian: Prizadeva si za čim večjo odprtost in preglednost o tem, kako doseže svoje znanstvene ugotovitve.
English: Information about these can normally be found on the websites of the national competent authorities:
Slovenian: Informacije o tem so običajno na voljo na spletiščih pristojnih nacionalnih organov:
English: He is responsible for all operational matters, staffing issues and drawing up the annual work programme.
Slovenian: Odgovoren je za vse operativne zadeve, kadrovska vprašanja in pripravo letnega delovnega programa.
English: Please note that the document contains links to sections of the EMA website, some of which are only available in English.
Slovenian: Opozarjamo vas, da dokument vsebuje povezave do razdelkov spletišča EMA, med katerimi so nekateri na voljo samo v angleščini.
English: Facilitate development and access to medicines
Slovenian: Omogočanje razvoja in dostopa do zdravil
English: If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
Slovenian: Če družba želi v več državah članicah EU zaprositi za dovoljenje za promet z zdravilom, ki ne spada na področje uporabe centraliziranega postopka, lahko uporabi eno od naslednjih poti:
English: It is consulted on the rules of procedure and the membership of the Agency's committees.
Slovenian: Z njim se posvetujejo o poslovniku in članstvu odborov agencije.
English: The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
Slovenian: Cilj je zbrati najboljše strokovno znanje za vrednotenje zdravil ne glede na to, kje se nahajajo strokovnjaki.
English: The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned.
Slovenian: Predstavnike držav članic, Evropske komisije in Evropskega parlamenta neposredno imenujejo države članice in zadevne institucije.
English: It bases these decisions on:
Slovenian: Te odločitve temeljijo na:
English: They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
Slovenian: Člani so izbrani tako, da zagotavljajo najvišje ravni specialističnih kvalifikacij, najrazličnejšo ustrezno strokovnost in najširšo možno geografsko razpršenost v EU.