natgillin/translations-raw huggingface dataset:
PP/Aluminium foil blisters in cartons of 10, 14, 28, 42 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Škatla po 10, 14, 28, 42 ali 98 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 100 filmsko obloženih tablet (10 enot po 10 x 1 filmsko obložena tableta).
Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "2.5" and a triangle on the other side.
FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) svetlo rumene, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »2.5« in trikotnikom
- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open.
Bodite posebno pozorni pri uporabi zdravila Xarelto - če pri vas obstaja večje tveganje za krvavitve, kar bi lahko bilo v primerih, kot so: huda bolezen ledvic, saj lahko delovanje ledvic vpliva na količino zdravila, ki učinkuje v vašem telesu če jemljete druga zdravila za preprečevanje nastanka krvnih strdkov (npr. varfarin, dabigatran eteksilat, apiksaban ali heparin), če ste zamenjali antikoagulacijsko zdravljenje ali ko dobivate heparin skozi venski ali arterijski kateter za vzdrževanje prehodnosti katetra (glejte poglavje »Druga zdravila in zdravilo Xarelto«)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 20 MG
PRETISNI OMOT S 14 TABLETAMI PO 20 MG
Clinically relevant non-major bleeding a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
++ Zdravilo Xarelto 10 mg enkrat na dan v primerjavi z acetilsalicilno kislino 100 mg enkrat na dan; razmerje tveganja = 0,32 (0,18-0,55), p < 0,0001 (nominalno)
Hypromellose 2910 Titanium dioxide (E 171) Iron oxide yellow (E 172)
Filmska obloga makrogol 3350 hipromeloza 2910 titanov dioksid (E 171)
EU/1/08/472/016 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/038 10 film-coated tablets
EU/1/08/472/015 10 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/016 100 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/038 10 filmsko obloženih tablet
- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke) - if you have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain's deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, nonlacunar stroke) in the previous month - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
apiksaban ali heparin), razen pri spremembi/zamenjavi antikoagulacijskega zdravljenja ali ko dobivate heparin skozi venski ali arterijski kateter za vzdrževanje prehodnosti katetra, - če imate akutni koronarni sindrom in ste predhodno imeli krvavitev ali krvni strdek v možganih (možgansko kap), - če imate bolezen jeter, ki lahko poveča tveganje za krvavitve, - če ste noseči ali dojite,
PP/Aluminium foil blisters in cartons of 10, 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Škatla po 10, 14, 28 ali 98 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 100 filmsko obloženih tablet (10 enot po 10 x 1 filmsko obložena tableta).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 15 MG
PRETISNI OMOT S 14 TABLETAMI PO 15 MG
Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side.
FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) svetlo rdeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »10« in trikotnikom
Hepatobiliary disorders
Srčne bolezni tahikardija
postoperative anaemia, and wound haemorrhage), contusion, wound secretionA
Bolezni sečil krvavitve v urogenitalnem traktu (tudi hematurija in menoragija
Bayer (logo)
Bayer OÜ
Relative Days from the Randomization
sekrecija iz raneA
Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0001 (non-inferiority to a prespecified HR of 1.75); HR: 0.886 (0.661 - 1.186)
Simptomatska ponovna GVT 32 Simptomatska PE in GVT 1 Smrtna PE/smrt, pri kateri PE ni mogoče izključiti Velike ali klinično pomembne majhne krvavitve Velike krvavitve a) rivaroksaban v odmerku 15 mg dvakrat na dan 3 tedne, nato pa odmerek po 20 mg enkrat na dan b) enoksaparin vsaj 5 dni, sočasno zdravljenje z AVK in enoksaparinom in nadaljevanje zdravljenja z AVK * p < 0,0001 (neinferiornost glede na predhodno opredeljeno razmerje tveganja 1,75); razmerje tveganja: 0,886 (0,661 - 1,186)
0.66 (0.46, 0.95) p = 0.026** a) modified intent to treat analysis set (intent to treat total analysis set for stent thrombosis) b) vs. placebo; Log-Rank p-value ** nominally significant
a) modificirana analiza z namenom zdravljenja (skupna analiza z namenom zdravljenja tromboze stenta) b) v primerjavi s placebom; p-vrednost Log-Rank
Uncommon (may affect up to 1 in 100 people) - bleeding into the brain or inside the skull - bleeding into a joint causing pain and swelling - thrombocytopenia (low number of platelets, which are cells that help blood to clot)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - krvavitev v možganih ali znotrajlobanjske krvavitve
Thrombocytosis (incl.
A, trombocitov) trombocitopenija
(See section 4.4 for haemodynamically unstable PE patients.)
GVT in PE pri odraslih bolnikih (glejte poglavje 4.4 glede podatkov o uporabi zdravila pri hemodinamsko nestabilnih bolnikih s PE).
For the primary efficacy outcome, the observed benefit of Xarelto 2.5 mg twice daily plus ASA 100 mg once daily compared with ASA 100 mg once daily was HR=0.89 (95% CI 0.7-1.1) in patients ≥75 years (incidence: 6.3% vs 7.0%) and HR=0.70 (95% CI 0.6-0.8) in patients <75 years (3.6% vs 5.0%).
Xarelto 2,5 mg dvakrat na dan, acetilsalicilna kislina 100 mg enkrat na dan acetilsalicilna kislina 100 mg enkrat na dan ocena po metodi Kaplan-Meier (%) po 30 mesecih: Xarelto 2,5 mg dvakrat na dan + acetilsalicilna kislina 100 mg enkrat na dan: 5,2 (4,7-5,8) acetilsalicilna kislina 100 mg enkrat na dan: 7,2 (6,5-7,9)
Weight:
Telesna masa:
The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a HR of 0.771 ((95% CI: 0.614 - 0.967), nominal p value p=
O vnaprej določeni čisti klinični koristi zdravljenja (primarni izid učinkovitosti in velike krvavitve) analize zbranih podatkov so poročali z razmerjem tveganja 0,771 ((95 % IZ: 0,614 - 0,967),
Total VTE 18 (1.1%) 58 (3.7%) < 0.001 17 (2.0%) 81 (9.3%) < 0.001 79 (9.6%) 166 (18.9%) < 0.001 Major
(95 % IZ 0,7 - 1,1) pri bolnikih ≥ 75 let (incidenca: 6,3 % oziroma 7, 0 %) in 0,70 (95 % IZ 0,60,8) pri bolnikih < 75 let (3,6 % oziroma 5,0 %).
♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Xarelto.
Informacije za zdravnika: ♦ Določanje vrednosti INR ni ustrezno merilo za merjenje antikoagulacijskega učinka zdravila
Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side.
FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) rjavordeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »20« in trikotnikom
Symptomatic recurrent DVT
simptomatske VTE
Day 1 - 21: 30 mg Day 22 and onwards: 20 mg
- 21. dan: 30 mg
ASA 100mg od: 7.2 (6.5 - 7.9)
Razmerje ogroženosti (95% IZ) 0,76 (0,66 do 0,86)
All doses should be taken every 12 hours.
Vse odmerke je treba jemati vsakih 12 ur.
If this is not possible, it may be taken with a light meal.
Če to ni mogoče, ga je mogoče vzeti tudi z lahkim obrokom.
The effectiveness of Zerit was assessed in four main studies.
Učinkovitost zdravila Zerit so ocenjevali v štirih glavnih študijah.
This study measured survival rates.
V tej študiji so merili stopnje preživetja.
The European Commission granted a marketing authorisation valid throughout the European Union for Zerit on 8 May 1996.
Evropska komisija je dovoljenje za promet z zdravilom Zerit, veljavno po vsej Evropski uniji, izdala 8. maja 1996.
Other information about Zerit
Druge informacije o zdravilu Zerit
The full EPAR for Zerit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zerit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is available as capsules containing 15, 20, 30 and 40 mg stavudine.
Na voljo je v obliki kapsul (15, 20, 30 in 40 mg).
The capsules should be swallowed whole or opened carefully and their contents mixed with food.
Kapsule mora bolnik pogoltniti cele ali pa jih previdno odpreti in njihovo vsebino zmešati s hrano.
The most common side effects when taking Zerit (seen in between 1 and 10 patients in 100) are peripheral neuropathy (damage to the nerves in the extremities causing tingling, numbness and pain in the hands and feet), diarrhoea, nausea, abdominal (stomach) pain, dyspepsia (heartburn), tiredness, lipoatrophy (a loss of fat in some areas of the body which can cause disfigurement), dizziness, insomnia (difficulty sleeping), abnormal thinking or dreams, somnolence (sleepiness), headache, depression, rash, pruritus (itching) and hyperlactataemia (elevated lactic acid levels in the blood).
Najpogostejši neželeni učinki, ki so jih opazili pri jemanju zdravila Zerit (opaženi pri med 1 in 10 bolniki od 100) so periferna nevropatija (poškodbe živcev okončin, kar povzroča ščemenje, odrevenelost in bolečino v rokah ter nogah), driska, slabost, abdominalne (trebušne) bolečine, dispepsija (zgaga), utrujenost, lipoatrofija (izguba maščevja na nekaterih delih telesa, kar lahko povzroči popačenje), vrtoglavica, nespečnost, nenormalno mišljenje, somnolenca (zaspanost), depresija, izpuščaj, pruritus (srbenje) in hiperlaktatemija (povišana raven mlečne kisline v krvi).
Patients taking either of two doses of Zerit also had similar survival rates over 22 weeks.
Bolniki, ki so jemali enega od obeh odmerkov zdravila Zerit, so imeli tudi podobne stopnje preživetja v času 22 tednov.
Patients taking Zerit should be assessed frequently.
Bolnike, ki jemljejo zdravilo Zerit, je treba redno spremljati.
What benefit has Zerit shown during the studies?
Kakšne koristi je zdravilo Zerit izkazalo med študijami?
Zerit should be taken on an empty stomach, at least one hour before a meal.
Zdravilo Zerit je treba vzeti na tešče vsaj eno uro pred obrokom.
What is the risk associated with Zerit?
Kakšna tveganja so povezana z zdravilom Zerit?
The second study compared two doses of Zerit in over 13,000 patients who did not respond to, or could not take, other types of antiviral medicine.
V drugi študiji so primerjali dva odmerka zdravila Zerit pri več kot 13 000 bolnikih, ki se niso odzivali oziroma niso mogli jemati drugih vrst protivirusnih zdravil.
The oral solution should be used in patients below three months of age.
Peroralna raztopina se uporablja pri bolnikih, mlajših od treh mesecev.
Zerit is used for as short a time as possible and only when other antiviral medicines cannot be used.
Zdravilo Zerit se uporablja kolikor je le mogoče malo časa in samo, če drugih protivirusnih zdravil ni mogoče uporabiti.
The patients' CD4 cell counts also rose from around 280 cells/mm3 before treatment by an average of around 185 cells/mm3.
Število celic CD4 pri bolnikih se je prav tako povečalo od približno 280 celic/mm3 pred zdravljenjem za povprečno vrednost okoli 185 celic/mm3.
This is a summary of the European public assessment report (EPAR) for Zerit.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zerit.
The dose to use is calculated based on the age and weight of the patient.
Odmerek, ki ga bo jemal bolnik, se izračuna na podlagi starosti in telesne mase bolnika.
The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T cells in the blood (CD4 cell count) after 48 weeks of treatment.
Glavna merila učinkovitosti so bile spremembe ravni virusa HIV v krvi (virusno breme) in števila T celic CD4 v krvi (števila celic CD4) po 48 tednih zdravljenja.
By blocking this enzyme, Zerit, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Z zaviranjem tega encima zdravilo Zerit v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
For more information about treatment with Zerit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zerit preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The studies showed that Zerit could reduce the rates of disease progression in HIV-infected patients.
Študije so pokazale, da lahko zdravilo Zerit upočasni hitrost napredovanja bolezni pri bolnikih, ki so okuženi z virusom HIV.
CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
T celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendar pa jih virus HIV ubija.
Zerit must not be used in people who are taking another HIV medicine called didanosine, which can also have toxic effects on mitochondria.
Zdravila Zerit ne smejo uporabljati osebe, ki že jemljejo drugo zdravilo za zdravljenje okužbe z virusom HIV, imenovano didanozin, ki ima prav tako lahko toksičen učinek na mitohondrije.
The CHMP decided that Zerit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Zerit večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Zerit is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), to je virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Zerit does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Zerit ne zdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, povezanih z njim.
Since its authorisation, post-marketing reports and published literature regarding the side effects of Zerit have led the CHMP to update the prescribing information for Zerit, recommending that it should be used for as short a time as possible and only when other antiviral medicines cannot be used.
Po izdaji dovoljenja za promet je Odbor na podlagi poročil po dajanju v promet in objavljene literature glede neželenih učinkov zdravila Zerit posodobil informacije o predpisovanju tega zdravila, in priporočil, naj se uporablja čim krajši čas in samo, kadar ni mogoče uporabiti drugih protivirusnih zdravil.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zerit.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zerit, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
These side effects are serious, usually appear with long-term use and are more commonly seen with Zerit than with other NRTI medicines.
Ti neželeni učinki so resni, navadno se pojavijo ob dolgotrajni uporabi in so bolj običajni ob uporabi zdravila Zerit kot drugih zaviralcev nukleozidne reverzne transkriptaze (NRTI).
Treatment with Zerit should be initiated by a doctor who has experience in the treatment of HIV infection.
Zdravljenje z zdravilom Zerit lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV.
Patients taking Zerit alone developed an AIDS-related disease or died at a similar rate to those taking zidovudine.
Bolniki, ki so jemali samo zdravilo Zerit, so razvili bolezni, povezane z aidsom, ali umrli podobno hitro kot tisti, ki so jemali zdravilo zidovudin.
The dose may need to be adjusted in patients who have problems with their kidneys or experience certain side effects.
Odmerek bo morda treba prilagoditi pri bolnikih z ledvičnimi težavami ali pri bolnikih, pri katerih se pokažejo nekateri neželeni učinki.
Its main measure of effectiveness was how long it took for the patients to develop a disease associated with AIDS or to die.
Glavno merilo učinkovitosti je bil čas, ki je pretekel, da so se pri bolnikih razvile bolezni, povezane z aidsom, ali pa da so umrli.
Why has Zerit been approved?
Zakaj je bilo zdravilo Zerit odobreno?
Zerit is to be used for as short a time as possible and the patients switched to appropriate alternatives whenever possible.
Zdravilo Zerit je namenjeno čim kratkotrajnejši uporabi, bolniki pa naj preidejo na drugo ustrezno zdravilo takoj, ko je mogoče.
Three side effects are possibly related to the medicine's toxic effect on mitochondria (the energyproducing components within cells): lipoatrophy, lactic acidosis (a build-up of lactic acid in the body) and peripheral neuropathy.
Trije neželeni učinki so verjetno povezani s toksičnim učinkom zdravila na mitohondrije (dele v celicah, ki proizvajajo energijo): lipoatrofija, aktacidoza (kopičenje mlečne kisline v telesu) in periferna nevropatija.
Adults weighing less than 60 kg and children weighing over 30 kg take a dose of 30 mg, and adults over 60 kg take 40 mg. Children over the age of 14 days receive 1 mg per kilogram body weight, unless they weigh more than 30 kg.
Odrasli, ki tehtajo manj kot 60 kg, in otroci, ki tehtajo več kot 30 kg, morajo vzeti 30-miligramski odmerek, odrasli, ki tehtajo več kot 60 kg, pa 40 mg.
When taken in combination with lamivudine and efavirenz, around 70% of the patients taking Zerit had viral loads below 400 copies/ml after 48 weeks.
Pri jemanju zdravila v kombinaciji z lamivudinom in efavirenzom je imelo po 48 tednih zdravljenja okoli 70 % bolnikov, ki so jemali tudi zdravilo Zerit, virusno breme pod 400 kopij/ml.
For the full list of side effects and restrictions with Zerit, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zerit glejte navodilo za uporabo.
Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz (other antiviral medicines) in 467 treatment-naïve patients (who had not taken treatment for HIV infection before).
V dveh nadaljnjih študijah so ocenjevali učinkovitost zdravila Zerit, ki so ga bolniki jemali v kombinaciji z lamivudinom in efavirenzom (drugima protivirusnima zdraviloma) pri 467 bolnikih, ki zaradi okužbe z virusom HIV še niso bili zdravljeni.
The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months.
V prvi študiji so primerjali učinke zdravila Zerit, ki so ga bolniki jemali kot samostojno zdravilo, z učinki zidovudina (drugega protivirusnega zdravila) pri 822 bolnikih, okuženih z virusom HIV, ki so zidovudin jemali vsaj šest mesecev.
The active substance in Zerit, stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Zdravilna učinkovina zdravila Zerit, stavudin, je nukleozidni zaviralec reverzne transkriptaze (NRTI).
Zerit is an antiviral medicine containing the active substance stavudine.
Zerit je zdravilo, ki vsebuje zdravilno učinkovino stavudin.
How is Zerit used?
Kako se zdravilo Zerit uporablja?
How has Zerit been studied?
Kako je bilo zdravilo Zerit raziskano?
Zerit is also available as a powder to make up into an oral solution.
Zdravilo Zerit je na voljo tudi v obliki praška za pripravo peroralne raztopine.
What is Zerit?
Kaj je zdravilo Zerit?
What is Zerit used for?
Za kaj se zdravilo Zerit uporablja?
Babies less than 13 days old should be given 0.5 mg/kg body weight.
Otroci, starejši od 14 dni, prejmejo 1 mg na kilogram telesne mase, razen če tehtajo več kot 30 kg. Dojenčki do 13. dne starosti smejo prejemati le 0,5 mg/kg telesne mase.
How does Zerit work?
Kako zdravilo Zerit deluje?
12 January 2015
12. januar 2015
Page 2/2
Vendar pa države stran 2/2
The European Commission issued an EU-wide legally binding decision on 12 January 2015.
Evropska komisija je 12. januarja 2015 izdala pravno zavezujoč sklep, veljaven po vsej Evropski uniji.
Why was Seasonique reviewed?
Zakaj je bilo zdravilo Seasonique pregledano?
This is a procedure where one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view to granting a marketing authorisation that will be valid in that country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and
To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Francija) oceni zdravilo z namenom odobritve dovoljenja za promet z zdravilom, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Belgija, Nemčija, Italija, Poljska, Romunija, Slovaška in Slovenija).
On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique.
Evropska agencija za zdravila je 26. junija 2014 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve peroralnega kontraceptiva Seasonique.