natgillin/translations-raw huggingface dataset:
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28, 30 and 84 film-coated tablets.
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Aluminijasti pretisni omoti v kartonskih škatlah, ki vsebujejo 14, 28, 30 in 84 filmsko obloženih tablet.
What Clopidogrel/Acetylsalicylic acid Zentiva looks like and contents of the pack
Izgled zdravila Klopidogrel/acetilsalicilna kislina Zentiva in vsebina pakiranja
The concomitant administration of Clopidogrel/Acetylsalicylic acid Zentiva with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Sočasna uporaba zdravila Klopidogrel/acetilsalicilna kislina Zentiva in varfarina ni priporočljiva, ker lahko poveča jakost krvavitev (glejte poglavje 4.5).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 30x1, 50x1, 90x1 and 100x1 tablets
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot / 30, 30x1, 50x1, 90x1 ali 100x1 tablet
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30x1, 50x1, 90x1 and 100x1 tablets
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot / 30x1, 50x1, 90x1 in 100x1 tablet
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Klopidogrel/acetilsalicilna kislina Zentiva«).
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Urikozuriki (benzbromaron, probenecid, sulfinpirazon) Potrebna je previdnost, kajti ASA lahko zavre učinek urikozuričnih zdravil s kompetitivno eliminacijo sečne kisline.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel/Acetylsalicylic acid Zentiva:
Opozorila in previdnostni ukrepi Če karkoli od spodaj naštetega velja za vas, morate o tem povedati svojemu zdravniku, preden vzamete zdravilo Klopidogrel/acetilsalicilna kislina Zentiva:
• Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
- akutnem koronarnem sindromu brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bila vstavljena opornica po perkutani koronarni intervenciji, - akutnem miokardnem infarktu z elevacijo ST spojnice pri bolnikih, ki se zdravijo z zdravili in so primerni za trombolitično zdravljenje.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28 and 84 film-coated tablets.
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Aluminijasti pretisni omoti v kartonskih škatlah, ki vsebujejo 14, 28 in 84 filmsko obloženih tablet.
You should specifically tell your doctor if you take
• morate povedati zdravniku:
While you are taking Clopidogrel/Acetylsalicylic acid Zentiva:
Ko jemljete zdravilo Klopidogrel/acetilsalicilna kislina Zentiva:
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
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.
Other medicinal products
FARMACEVTSKI PODATKI
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.
Bolnikom morate povedati, da se jim lahko med jemanjem zdravila Klopidogrel/acetilsalicilna kislina Zentiva krvavitve ustavijo počasneje kot ponavadi.
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.
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.
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.
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.
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).
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).
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).
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).
If you stop taking Clopidogrel/Acetylsalicylic acid Zentiva Do not stop the treatment unless your doctor tells you so.
Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva morate jemati toliko časa, kot vam je naročil zdravnik.
How to store Clopidogrel/Acetylsalicylic acid Zentiva
Shranjevanje zdravila Klopidogrel/acetilsalicilna kislina Zentiva
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
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
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
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
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
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
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.
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.
If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets The active substances are clopidogrel and acetylsalicylic acid (ASA).
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete Zdravilni učinkovini sta klopidogrel in acetilsalicilna kislina (ASA).
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Red iron oxide (E172)
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)
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.
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.
Do not take Clopidogrel/Acetylsalicylic acid Zentiva
Ne jemljite zdravila Klopidogrel/acetilsalicilna kislina Zentiva:
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg
PODATKI V BRAILLOVI PISAVI Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg
PODATKI V BRAILLOVI PISAVI Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg
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).
Varnost sočasne uporabe zdravila Klopidogrel/acetilsalicilna kislina Zentiva z drugimi trombolitiki ni formalno ugotovljena.
In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Študije in vitro so pokazale, da se izpostavljenost repaglinidu poveča zaradi zavrtja
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.
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.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg filmsko obložene tablete Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete
What Clopidogrel/Acetylsalicylic acid Zentiva contains
Kaj vsebuje zdravilo Klopidogrel/acetilsalicilna kislina Zentiva
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.
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.
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Yellow iron oxide (E172)
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)
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
- 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.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
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
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
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
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*.
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
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete
You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Zentiva.
Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel/acetilsalicilna kislina Zentiva
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg tablets clopidogrel/acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg tablete klopidogrel/acetilsalicilna kislina
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/75 mg tablete klopidogrel/acetilsalicilna kislina
Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva vsebuje hidrogenirano ricinusovo olje.
Therapeutic experience is limited in patients with mild to moderate renal impairment (see section 4.4).
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).
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Klopidogrel/acetilsalicilna kislina Zentiva 75 mg/100 mg filmsko obložene tablete klopidogrel / acetilsalicilna kislina
28 March 2019
28. marca 2019
It began operating in 1995.
Delovati je začela leta 1995.
The revised policy entered into force on 30 January 2015.
Nova, spremenjena politika je začela veljati 30. januarja 2015.
Annual review of policies on independence
Letni pregled politik o neodvisnosti
The Agency has separate policies in place for these groups.
Za te skupine je sprejela ločene politike.
Each EU Member State has its own national authorisation procedures.
Vsaka država članica EU ima svoje nacionalne postopke izdaje dovoljenj.
This supports an exchange of information on a number of issues, including:
S tem se podpira izmenjava informacij o številnih vprašanjih, vključno z:
EMA subsequently updated the policy:
Agencija EMA je pozneje politiko posodobila:
• the Innovation Task Force, a forum for early dialogue with applicants.
• projektna skupina za inovacije, forum za zgodnji dialog s predlagatelji.
Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
Omejitve vključevanja se sčasoma zmanjšujejo, pri čemer obstaja razlika med trenutnimi interesi in interesi v zadnjih treh letih;
• for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.
• za nekatere interese, kot so finančni, se še naprej ne zahteva obdobje mirovanja, če interes ne obstaja več.
• whose authorisation would be in the interest of public or animal health at EU level.
• katerih odobritev bi bila v interesu javnega zdravja ali zdravja živali na ravni EU.
All other DoIs are available on request.
Vse druge izjave o interesih so na voljo na zahtevo.
New staff must get rid of any interests they have before they can start to work at the Agency.
Novo zaposlene osebe se morajo odpovedati vsem interesom, ki jih imajo, preden lahko začnejo delati pri agenciji.
The centralised procedure is compulsory for:
Centralizirani postopek je obvezen za:
• Accelerates the exchange of information on important issues, such as the safety of medicines.
• Pospešuje izmenjavo informacij o pomembnih vprašanjih, kakršno je varnost zdravil.
Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.
Podobno so zahteve za predsednike in člane z vodilno vlogo, npr. poročevalce, strožje od zahtev za druge člane odborov.
The system for regulating medicines in Europe is unique in the world.
Sistem zakonske ureditve zdravil v Evropi je edinstven na svetu.
Experts can only be involved once the Agency has assessed their declaration of interests.
Strokovnjaki se lahko vključijo šele po tem, ko je agencija ocenila njihovo izjavo o interesih.
Board members are appointed for a three-year term, which may be renewed.
Člani upravnega odbora se imenujejo za triletno obdobje, ki se lahko podaljša.
• support for early access;
• podpora za zgodnji dostop;
Provide information to healthcare professionals and patients
Zagotavljanje informacij zdravstvenim delavcem in bolnikom
EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Agencija EMA je decentralizirana agencija Evropske unije (EU) s sedežem v Amsterdamu.
• for the majority of declared interests a three-year cooling-off period is foreseen.
• za večino prijavljenih interesov je predvideno triletno obdobje mirovanja.
For more information, see Section 3.1.
Več informacij je na voljo v razdelku 3.1.
• developing guidelines and setting standards;
• razvija smernice in določa standarde;
The report includes results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.
Poročilo vsebuje rezultate postopkov za obravnavo zlorabe zaupanja, vsa opravljena preverjanja, pobude, načrtovane za naslednje leto, in priporočila za izboljšave.
• the type of activity that the expert will be undertaking.
• vrsti dejavnosti, ki jo bo izvajal strokovnjak.
The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.
Za doseganje teh ciljev uporablja različne regulativne mehanizme, ki jih nenehno pregleduje in izboljšuje.
• the time since the interest occurred;
• času, ki je pretekel, odkar se je pojavil interes;
The Agency publishes clear and impartial information about medicines and their approved uses.
Agencija objavlja jasne in nepristranske informacije o zdravilih in njihovih odobrenih uporabah.
The Management Board is made up of the following members:
Upravni odbor ima naslednje člane:
The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Upravni odbor sestavlja 35 članov, ki se imenujejo za delovanje v javnem interesu ter ne zastopajo vlad, organizacij ali sektorja.
EMA strives towards being as open and transparent as possible about how it reaches its scientific conclusions.
Prizadeva si za čim večjo odprtost in preglednost o tem, kako doseže svoje znanstvene ugotovitve.
Information about these can normally be found on the websites of the national competent authorities:
Informacije o tem so običajno na voljo na spletiščih pristojnih nacionalnih organov:
He is responsible for all operational matters, staffing issues and drawing up the annual work programme.
Odgovoren je za vse operativne zadeve, kadrovska vprašanja in pripravo letnega delovnega programa.