natgillin/translations-raw huggingface dataset:
4.4)** , insulin autoimmun syndrom, som kan føre til alvorlig hypoglykæmi, især hos patienter med HLA DRA4 subtype (hyppigere i den japanske befolkning)**, forværring af symptomer på fødeallergi*
Anaphylactic shock*, serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)**,insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)**, aggravation of allergic symptoms of food allergy*
Clopidogrel/Acetylsalicylsyre Zentiva indeholder hydrogeneret ricinusolie Clopidogrel/Acetylsalicylsyre Zentiva indeholder hydrogeneret ricinusolie, der kan forårsage mavetilfælde eller diaré.
Clopidogrel/Acetylsalicylic acid Zentiva contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Zentiva
What you need to know before you take Clopidogrel/Acetylsalicylic acid Zentiva
Det vides ikke, om ASA-dosen i Clopidogrel/Acetylsalicylsyre Zentiva påvirker fertiliteten.
It is unknown whether ASA dose in Clopidogrel/Acetylsalicylic acid Zentiva alters fertility.
Du skal holde op med at tage andre lægemidler, der indeholder clopidogrel, mens du tager Clopidogrel/Acetylsalicylsyre Zentiva.
You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Zentiva.
Clopidogrel/Acetylsalicylsyre Zentiva udleveres i pakninger, der indeholder: - 14, 28 og 84 tabletter i aluminiumblister, - 30x1, 50x1, 90x1 eller 100x1 tabletter i perforerede enkeltdosisblister i aluminium.
Clopidogrel/Acetylsalicylic acid Zentiva is supplied in cardboard cartons containing: - 14, 28 and 84 tablets in all-aluminium blisters - 30x1, 50x1, 90x1 and 100x1 tablet in all-aluminium perforated unit-dose blisters.
• skal du fortælle lægen, at du er i behandling med Clopidogrel/Acetylsalicylsyre Zentiva: hvis du skal have foretaget en planlagt operation (også hos tandlægen).
• You should tell your doctor - if a surgery (including dental) is planned.
Clopidogrel/Acetylsalicylsyre Zentiva udleveres i pakninger, der indeholder - 14, 28, 30 og 84 tabletter i aluminiumblister, - 30x1, 50x1, 90x1 eller 100x1 tabletter i perforerede enkeltdosisblister i aluminium.
Clopidogrel/Acetylsalicylic acid Zentiva is supplied in cardboard cartons containing: - 14, 28, 30 and 84 tablets in all-aluminium blisters - 30x1, 50x1, 90x1 and 100x1 tablet in all-aluminium perforated unit-dose blisters.
Antallet af patienter, som oplevede det primære sammensatte endepunkt [kardiovaskulær død, myokardieinfarkt, apopleksi eller refraktær iskæmi] var 1.035 (16,5 %) i clopidogrel plus ASAgruppen og 1.187 (18,8 %) i ASA-gruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI:
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel plus ASA group and 1,187 (18.8%) in the ASA group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel plus ASA group.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Blisterkort af aluminium i kartonæsker der indeholder 14, 28, 30 og 84 filmovertrukne tabletter.
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.
Clopidogrel/Acetylsalicylsyre Zentiva må ikke anvendes hos patienter med stærkt nedsat leverfunktion (se pkt.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used in patients with severe renal impairment (see section 4.3).
Advarsler og forsigtighedsregler Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til lægen, før du tager Clopidogrel/Acetylsalicylsyre Zentiva:
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel/Acetylsalicylic acid Zentiva:
Urikosurika (benzbromaron, probenecid, sulfinpyrazon) Der skal udvises forsigtighed, da ASA kan hæmme effekten af urikosurika via kompetitiv elimination af urinsyre.
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Graviditet Der er ingen data fra anvendelse af Clopidogrel/Acetylsalicylsyre Zentiva til gravide kvinder.
No clinical data on exposure to Clopidogrel/Acetylsalicylic acid Zentiva during pregnancy are available.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Blisterkort af aluminium i kartonæsker der indeholder 14, 28 og 84 filmovertrukne tabletter.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28 and 84 film-coated tablets.
EU1/10/623/008 14 filmovertrukne tabletter EU1/10/623/009 28 filmovertrukne tabletter EU1/10/623/010 30x1 filmovertrukne tabletter EU1/10/623/011 50x1 filmovertrukne tabletter EU1/10/623/012 84 filmovertrukne tabletter EU1/10/623/013 90x1 filmovertrukne tabletter EU1/10/623/014 100x1 filmovertrukne tabletter
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
EU1/10/623/001 14 filmovertrukne tabletter EU1/10/623/002 28 filmovertrukne tabletter EU1/10/623/003 30x1 filmovertrukne tabletter EU1/10/623/004 50x1 filmovertrukne tabletter EU1/10/623/005 84 filmovertrukne tabletter EU1/10/623/006 90x1 filmovertrukne tabletter EU1/10/623/007 100x1 filmovertrukne tabletter EU1/10/623/015 30 filmovertrukne tabletter
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
Som forholdsregel frarådes samtidig anvendelse af potente eller moderate CYP2C19-hæmmere (se også pkt.
As a precaution, concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Mens du er i behandling med Clopidogrel/Acetylsalicylsyre Zentiva:
While you are taking Clopidogrel/Acetylsalicylic acid Zentiva:
Carnaubavoks
Thrombolytics
Clopidogrel/Acetylsalicylsyre Zentiva indeholder:
What Clopidogrel/Acetylsalicylic acid Zentiva contains
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (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).
Sådan skal du tage Clopidogrel/Acetylsalicylsyre Zentiva
How to take Clopidogrel/Acetylsalicylic acid Zentiva
Øvrige indholdsstoffer: - Tabletkernen: mannitol (E421), macrogol 6000, mikrokrystallinsk cellulose, lavsubstitueret hydroxypropylcellulose, majsstivelse, hydrogeneret ricinusolie (se afsnit 2 ‘Clopidogrel/Acetylsalicylsyre Zentiva indeholder hydrogeneret ricinusolie'), stearinsyre og kolloid vandfri silica.
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
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg
Samtidig indgift af heparin havde ingen virkning på den hæmning af trombocytaggregationen, som Clopidogrel/Acetylsalicylsyre Zentiva inducerer.
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg
Da clopidogrel til dels metaboliseres til dets aktive metabolit af CYP2C19, kan anvendelse af medicin,
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
This leaflet was last revised in <Month YYYY>.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
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).
Tag ikke Clopidogrel/Acetylsalicylsyre Zentiva:
Do not take Clopidogrel/Acetylsalicylic acid Zentiva
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Aktive stoffer: clopidogrel og acetylsalicylsyre (ASA).
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets The active substances are clopidogrel and acetylsalicylic acid (ASA).
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Lys pink, oval, lettere bikonveks, med "C75" præget på den ene side og ”A100” på den anden side.
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.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter (tabletter) er ovale, let bikonvekse, gule og er præget på den ene side med "C75" og på den anden side med "A75".
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.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Gul, oval, lettere bikonveks, med "C75" præget på den ene side og ”A75” på den anden side.
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.
Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Zentiva Sådan skal du tage Clopidogrel/Acetylsalicylsyre Zentiva Bivirkninger
What Clopidogrel/Acetylsalicylic acid Zentiva is and what it is used for What you need to know before you take Clopidogrel/Acetylsalicylic acid Zentiva How to take Clopidogrel/Acetylsalicylic acid Zentiva Possible side effects
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylsyre Zentiva tages af voksne for at forebygge dannelse af blodpropper i blodårer, som er blevet stive.
Clopidogrel/Acetylsalicylic acid Zentiva is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter (tabletter) er ovale, let bikonvekse, lyserøde og er præget på den ene side med "C75" og på den anden side med "A100".
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.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylsyre Zentiva bør gives som en enkelt daglig dosis på 75 mg/75 mg.
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.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
- Tablettens overtræk: lactosemonohydrat (se afsnit 2 ‘Clopidogrel/Acetylsalicylsyre Zentiva indeholder lactose'), hypromellose (E464), titandioxid (E171), triacetin (E1518), rød jernoxid (E172) - Polérmiddel: carnaubavoks.
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
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylsyre Zentiva bør gives som en enkelt daglig dosis på 75 mg/100 mg. Clopidogrel/Acetylsalicylsyre Zentiva fast dosiskombination anvendes efter indledning af behandling med clopidogrel og ASA givet separat, og erstatter de individuelle clopidogrel og ASA produkter.
Clopidogrel/Acetylsalicylic acid Zentiva fixed-dose combination is used following initiation of therapy with clopidogrel and ASA given separately, and replaces the individual clopidogrel and ASA products.
Under alle omstændigheder skal du fortsætte med at tage Clopidogrel/Acetylsalicylsyre Zentiva, så længe din læge udskriver det til dig.
In any case, you should take it for as long as your doctor continues to prescribe it.
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/75 mg tabletter clopidogrel/acetylsalicylsyre
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg tablet clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylsyre Zentiva 75 mg/100 mg tabletter clopidogrel/acetylsalicylsyre
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg tablet clopidogrel/acetylsalicylic acid
28. marts 2019
28 March 2019
Det indledte sin virksomhed i 1995.
It began operating in 1995.
Den reviderede politik trådte i kraft den 30. januar 2015.
The revised policy entered into force on 30 January 2015.
Agenturet har særskilte politikker for disse grupper.
The Agency has separate policies in place for these groups.
Denne begrænsning fremgår af det vejledende dokument.
This restriction is reflected in the guidance document.
Hver EU-medlemsstat har sine egne nationale godkendelsesprocedurer.
Each EU Member State has its own national authorisation procedures.
Den er fakultativ for andre lægemidler:
It is optional for other medicines:
• den type aktivitet, som eksperten skal udføre.
• the type of activity that the expert will be undertaking.
Begrænsningen af vedkommendes deltagelse vil blive reduceret over tid, og der skelnes mellem aktuelle interesser og interesser inden for de sidste tre år
Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
Dette støtter udveksling af oplysninger om en række spørgsmål, herunder:
This supports an exchange of information on a number of issues, including:
• Innovationstaskforcen, et forum for tidlig dialog med ansøgerne.
• the Innovation Task Force, a forum for early dialogue with applicants.
• Gennemsigtighed
• Transparency
Årlig gennemgang af politikkerne om uafhængighed
Annual review of policies on independence
Bestyrelsen består af følgende medlemmer:
The Management Board is made up of the following members:
Yderligere oplysninger findes i afsnit 3.1.
For more information, see Section 3.1.
• En enkelt vurdering foretaget af europæiske eksperter.
• Single evaluation by European experts.
EMA tilstræber at være så åbent og gennemsigtigt som muligt om, hvordan det når frem til sine videnskabelige konklusioner.
EMA strives towards being as open and transparent as possible about how it reaches its scientific conclusions.
Den centrale procedure er obligatorisk for:
The centralised procedure is compulsory for:
Oplysninger om disse procedurer kan normalt findes på de nationale kompetente myndigheders websteder:
Information about these can normally be found on the websites of the national competent authorities:
EMA er involveret i vurderingen af visse kategorier af medicinsk udstyr.
EMA is involved in the assessment of certain categories of medical devices.
Medicinsk udstyr reguleres af nationale kompetente myndigheder i Europa.
Medical devices are regulated by national competent authorities in Europe.
EMA ledes af en uafhængig bestyrelse.
EMA is governed by an independent Management Board.
• der indeholder nye aktive stoffer for andre indikationer end dem, der er anført ovenfor
• containing new active substances for indications other than those stated above;
EMA er et decentralt agentur i Den Europæiske Union (EU) og ligger i Amsterdam.
EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Efterfølgende opdaterede EMA politikken med henblik på at:
EMA subsequently updated the policy:
De kan udpeges af medlemsstaterne eller af agenturet selv og stilles til rådighed af de nationale kompetente myndigheder.
They can be nominated by Member States or by the Agency itself and are made available by the national competent authorities.
• udarbejde retningslinjer og fastsætte standarder
• developing guidelines and setting standards;
Alle andre interesseerklæringer kan fås på anmodning.
All other DoIs are available on request.
• støtte til tidlig adgang
• support for early access;
• for nogle interessers vedkommende, f.eks. økonomiske interesser, vil nedkølingsperioden bortfalde, når interessen ikke længere er til stede.
• for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.
• Fremskynder udvekslingen af oplysninger om vigtige spørgsmål, såsom lægemiddelsikkerheden.
• Accelerates the exchange of information on important issues, such as the safety of medicines.
Fremme udvikling og adgang til lægemidler
Facilitate development and access to medicines
Rapporten indeholder resultaterne af tillidsbrudprocedurer, eventuelle gennemførte tilsyn, planlagte initiativer for det kommende år og anbefalinger til forbedring.
The report includes results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.
Bestyrelsesmedlemmerne udpeges for tre år, og deres mandat kan fornyes.
Board members are appointed for a three-year term, which may be renewed.
På samme vis er kravene til formænd og medlemmer med en ledende rolle, f.eks. rapportører, strengere end kravene til øvrige udvalgsmedlemmer.
Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.
Repræsentanterne for medlemsstaterne, Europa-Kommissionen og Europa-Parlamentet udpeges direkte af den pågældende medlemsstat og institution.
The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned.
Bestyrelsen består af 35 medlemmer, der er udpeget til at handle i offentlighedens interesse, og som ikke repræsenterer nogen offentlig myndighed, organisation eller sektor.
The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Eksperterne kan først deltage, når agenturet har vurderet deres interesseerklæring.
Experts can only be involved once the Agency has assessed their declaration of interests.
Det europæiske netværk for regulering af lægemidler er hjørnestenen i EMA's arbejde og succes.
The European medicines regulatory network is the cornerstone of EMA's work and success.
Bemærk, at dokumentet indeholder links til sektioner på EMA's websted, hvoraf nogle kun er tilgængelige på engelsk.
Please note that the document contains links to sections of the EMA website, some of which are only available in English.
Alle lægemidler skal godkendes, inden de kan markedsføres og udleveres til patienterne.
All medicines must be authorised before they can be marketed and made available to patients.
Systemet til regulering af lægemidler i Europa er unikt på verdensplan.
The system for regulating medicines in Europe is unique in the world.
Ikke alle aspekter af lægemiddelregulering i EU er omfattet af agenturets ansvarsområde.
Not all aspects of medicine regulation in the EU fall under the remit of the Agency.
• Produktinformation er tilgængelig på alle EU-sprog på samme tid.
• Product information available in all EU languages at the same time.
For at nå disse mål anvender agenturet en lang række reguleringsmekanismer, som løbende gennemgås og forbedres.
The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.
Foruden medlemmerne har bestyrelsen også en observatør fra henholdsvis Island, Liechtenstein og Norge.
In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
Dette omfatter offentlige versioner af videnskabelige vurderingsrapporter og sammendrag skrevet i letforståeligt sprog.
This includes public versions of scientific assessment reports and summaries written in lay language.
• hvor længe siden interessen opstod
• the time since the interest occurred;
− human immundefekt virus (HIV) eller erhvervet immundefektsyndrom (AIDS)
− human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
Den omfatter en række foranstaltninger, der tager højde for den oplyste interesses art, før der træffes afgørelse om varigheden af eventuelle begrænsninger:
It includes a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:
Repræsentanterne for medlemsstaterne og Kommissionen kan have suppleanter.
The representatives of the Member States and of the Commission may have alternates.
Europa-Kommissionen udarbejder EUlovgivning vedrørende lægemidler, og Europa-Parlamentet vedtager den sammen med Rådet for Den Europæiske Union.
The European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt it.
EMA er en netværksorganisation, hvis aktiviteter involverer flere tusinde eksperter fra hele Europa.
EMA is a networking organisation whose activities involve thousands of experts from across Europe.