FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg twice daily group, 88 in the nilotinib 400 mg twice daily group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Croatian: Kod ukupno 305 (36,1%) bolesnika nije bilo moguće ocijeniti MMR u 48. mjesecu (98 u skupini koja je primala 300 mg dva puta na dan, 88 u skupini koja je primala 400 mg dva puta na dan i 119 u skupini koja je primala imatinib) zbog nedostajućih/neocjenjivih PCR nalaza (n=18), atipičnih transkripcija na početku (n=8) ili prekida sudjelovanja prije vremenske točke u 48. mjesecu (n=279).
English: Rare cases of tumour lysis syndrome have been reported in patients treated with Tasigna.
Croatian: U bolesnika liječenih Tasignom prijavljeni su rijetki slučajevi sindroma lize tumora.
English: By 12 months
Croatian: Vrlo često 12
English: Endocrine disorders Uncommon:
Croatian: Preosjetljivost Endokrini poremećaji Manje često:
English: 18 <1 Very common
Croatian: <1 Vrlo često 20
English: Multipack: 112 (4 wallets of 28) hard capsules.
Croatian: Višestruko pakiranje: 112 (4 džepna pakiranja po 28) tvrdih kapsula.
English: Pat
Croatian: Dog
English: Drug eruption, skin pain
Croatian: Izbijanje kožnih promjena uzrokovano lijekom, kožna bol
English: Co-morbidities in addition to the underlying malignancy were also frequently present as were concomitant medicinal products.
Croatian: Često se radilo o bolesnicima koji su uz osnovnu malignu bolest imali značajan komorbiditet te konkomitantnu terapiju.
English: The following other side effects have been reported with frequency not known (cannot be estimated from the available data): - allergy (hypersensitivity to Tasigna) - memory loss, disturbed mood - skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, fungal infection of the feet - thickened patches of red/silver skin (signs of psoriasis) - bleeding, tender or enlarged gums - oral warts - reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot syndrome) - increased sensitivity of the skin to light - difficulty hearing, ear pain, noises (ringing) in the ears - joint inflammation - urinary incontinence - enterocolitis (inflammation of the bowel) - haemorrhoids, anal abscess - feeling of hardening in the breasts, heavy periods, nipple swelling - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Croatian: gljivična infekcija stopala - mjestimično zadebljana i crvena/srebrna koža (znakovi psorijaze) - krvarenje, napetost ili otok desni - bradavice u ustima - crvenilo i/ili oticanje i moguće ljuštenje dlanova i tabana (takozvani sindrom šaka-stopalo) - pojačana osjetljivost kože na svjetlo - problemi sa sluhom, bol u uhu, šum (zvonjenje) u ušima - upala zglobova - potreba za mokrenjem uz nekontrolirano istjecanje mokraće - enterokolitis (upala crijeva) - hemoroidi, analne lokalizirane gnojne nakupine - osjećaj otvrdnuća grudi, jake mjesečnice, oticanje bradavica - simptomi sindroma nemirnih nogu (neodoljiva potreba za pomicanjem dijela tijela, obično noge,
English: 88.6-96.4%) in the nilotinib 300 mg twice daily group, 92.2% (95% CI: 88.5-95.9%) in the nilotinib 400 mg twice daily group and 88.0% (95% CI: 83.0-93.1%) in the imatinib 400 mg once daily group.
Croatian: Na temelju Kaplan-Meierovih procjena trajanja prvog MMR-a, udjeli bolesnika koji su održavali odgovor tijekom 72 mjeseca među bolesnicima koji su postigli MMR bili su 92,5% (95% CI: 88,6-96,4%) u skupini koja je primala 300 mg nilotiniba dva puta na dan, 92,2% (95% CI: 88,5-95,9%) u skupini koja je primala 400 mg nilotiniba dva puta na dan te 88,0% (95% CI: 83,0-93,1%) u skupini koja je primala 400 mg imatiniba jedanput na dan.
English: PVC/PVDC/Alu blisters.
Croatian: 6.5 Vrsta i sadržaj spremnika PVC/PVDC/Al blisteri.
English: 9/l and/or platelets >50 x 10 9/l.
Croatian: 9/l i/ili trombociti <50 x 10
English: What Tasigna looks like and contents of the pack Tasigna is supplied as hard capsules.
Croatian: Tasigna je dostupna u obliku tvrdih kapsula.
English: What you need to know before you take Tasigna
Croatian: Što morate znati prije nego počnete uzimati Tasignu Pažljivo slijedite upute liječnika.
English: Hypertension, flushing
Croatian: Hipertenzija, navale crvenila
English: • Pack containing 120 (3 packs of 40) hard capsules.
Croatian: • pakiranje koje sadrži 120 (3 pakiranja po 40) tvrdih kapsula Tasigna 200 mg tvrde kapsule
English: Evt
Croatian: Osip
English: CMLAP n=137 Grade
Croatian: KMLubrzana faza n=137 stupanj
English: Ventricular repolarisation abnormalities may have been contributory factors.
Croatian: Jedan od mogućih uzroka iznenadne smrti su i smetnje repolarizacije ventrikula.
English: Table 7 MMR rate
Croatian: Tablica 7 Stopa velikog molekularnog odgovora (MMR)
English: Pollakiuria
Croatian: Vrtoglavica
English: <1 Very common
Croatian: <1 Vrlo često 24
English: 14 <1 Very common
Croatian: Vrlo često 14
English: 33 <1 Very common
Croatian: Vrlo često 33
English: Shellac
Croatian: Polakisurija
English: What is the outcome of the review?
Croatian: Koji je rezultat pregleda?
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Croatian: Pregled je proveo Odbor EMA-e za lijekove za humanu uporabu (CHMP), nadležan za pitanja koja se odnose na lijekove za primjenu u ljudi.
English: However, the Member States were not able to reach an agreement and the Spanish medicines agency referred the matter to EMA for arbitration on 10 June 2019.
Croatian: Međutim, države članice nisu uspjele postići dogovor pa je 10. lipnja 2019. španjolska agencija za lijekove uputila predmet EMA-i na arbitražni postupak.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, the Netherlands, Portugal and Slovakia) where the company has applied for a marketing authorisation.
Croatian: To je postupak u kojemu jedna država članica („referentna država članica”, u ovom slučaju Španjolska) ocjenjuje lijek radi izdavanja odobrenja za njegovo stavljanje u promet koje će biti valjano u toj državi i u drugim državama članicama („predmetne države članice”, u ovom slučaju Češka, Nizozemska, Portugal i Slovačka) u kojima je tvrtka podnijela zahtjev za izdavanje odobrenja za stavljanje u promet.
English: The review of Flurbiprofen Geiser was initiated on 27 June 2019 at the request of Spain, under Article 29(4) of Directive 2001/83/EC.
Croatian: Pregled lijeka Flurbiprofen Geiser započeo je 27. lipnja 2019. na zahtjev Švedske u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: Since some prostaglandins are involved in causing pain and inflammation in the body, reducing prostaglandin production reduces pain and inflammation.
Croatian: Budući da neki prostaglandini uzrokuju bol i upale u tijelu, smanjenje njihove proizvodnje smanjuje bol i upalu.
English: Because there is a small difference in concentration between the two medicines, it was considered that data from a clinical trial in healthy volunteers would be needed to determine whether they have the same effect.
Croatian: da postoji mala razlika u koncentraciji dvaju lijekova, smatra se da su za utvrđivanje njihova jednakog učinka potrebni podatci iz kliničkog ispitivanja u zdravih dobrovoljaca.
English: This is supported by data showing that even flurbiprofen medicines taken by mouth in very different forms, such as lozenges, granules and spray, behave the same way in the body.
Croatian: To je potkrijepljeno podatcima koji pokazuju da se čak i lijekovi koji sadrže flurbiprofen i uzimaju se oralno u vrlo različitim oblicima, na primjer u obliku pastila, granula i spreja, ponašaju u tijelu na isti način.
English: The Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and the marketing authorisation can be granted in Spain and in other Member States of the EU where the company has applied for a marketing authorisation: Czech Republic, the Netherlands, Portugal and Slovakia.
Croatian: Agencija je zaključila da koristi od lijeka Flurbiprofen Geiser nadmašuju s njim povezane rizike te da se odobrenje za stavljanje u promet može izdati u Španjolskoj i drugim državama članicama EU-a u kojima je tvrtka podnijela zahtjev za stavljanje u promet: Češka, Nizozemska, Portugal i Slovačka.
English: Flurbiprofen Geiser was developed as a ‘hybrid medicine'.
Croatian: Flurbiprofen Geiser je razvijen kao „hibridni lijek”.
English: On 17 October 2019, the European Medicines Agency completed a review of Flurbiprofen Geiser following a disagreement among EU Member States regarding its authorisation.
Croatian: Europska agencija za lijekove završila je 17. listopada 2019. pregled lijeka Flurbiprofen Geiser nakon neslaganja među državama članicama EU-a u pogledu izdavanja odobrenja za predmetni lijek.
English: EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU EMA/631051/2019
Croatian: EMA preporučuje izdavanje odobrenja za lijek Flurbiprofen Geiser (flurbiprofen, 8,75 mg, oromukozni sprej) u EU-u EMA/631051/2019
English: Why was Flurbiprofen Geiser reviewed?
Croatian: Zašto je lijek Flurbiprofen Geiser pregledan?
English: Flurbiprofen Geiser is a medicine used for the short-term relief of symptoms of sore throat.
Croatian: Flurbiprofen Geiser je lijek koji se koristi za kratkotrajno olakšanje simptoma grlobolje.
English: Published data show that differences of this size in concentration of the active substance, flavour and amount of cyclodextrins do not affect how the medicine works.
Croatian: Objavljeni podatci pokazuju da takve razlike u koncentraciji djelatne tvari, okusu i količini ciklodekstrina ne utječu na djelovanje lijeka.
English: EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU
Croatian: EMA preporučuje izdavanje odobrenja za lijek Flurbiprofen Geiser (flurbiprofen, 8,75 mg, oromukozni sprej) u EU-u
English: Having reviewed the available data, EMA considered that differences between Flurbiprofen Geiser and Strefen Direct are minor and do not affect the amount of active substance that is released in the mouth and into the bloodstream.
Croatian: Nakon što je EMA pregledala dostupne podatke, zaključeno je da su razlike između lijekova Flurbiprofen Geiser i Strefen Direct male i ne utječu na količinu djelatne tvari koja se ispušta u usta i krvotok.
English: The grounds for the referral were concerns that the laboratory data submitted were not enough to show that Flurbiprofen Geiser is equally as effective as Strefen Direct.
Croatian: Razlog za pokretanje arbitražnog postupka bila je sumnja na to da podneseni laboratorijski podatci nisu u dovoljnoj mjeri dokazali da je Flurbiprofen Geiser jednako učinkovit kao Strefen Direct.
English: Based on evaluation of the currently available data, the Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and therefore the marketing authorisation for Flurbiprofen Geiser should be granted in all concerned Member States.
Croatian: Stoga je Agencija na temelju ocjene dostupnih podataka zaključila da koristi od lijeka Flurbiprofen Geiser nadmašuju s njim povezane rizike i da bi trebalo izdati odobrenje za stavljanje u promet lijeka Flurbiprofen Geiser u svim predmetnim državama članicama.
English: Flurbiprofen Geiser contains the active substance flurbiprofen, a 'non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Croatian: Flurbiprofen Geiser sadrži djelatnu tvar flurbiprofen, nesteroidni protuupalni lijek (NSAID) koji smanjuje proizvodnju prostaglandina u tijelu.
English: However, the reference medicine, Strefen Direct, has a different concentration to Flurbiprofen Geiser.
Croatian: No, referentni lijek Strefen Direct ima različitu koncentraciju u odnosu na Flurbiprofen Geiser.
English: The medicines also have different flavours and different amounts of cyclodextrins and this could affect how the active substance is taken up into the body.
Croatian: Lijekovi imaju i različit okus te različitu količinu ciklodekstrina te bi to moglo utjecati na način razlaganja djelatne tvari u tijelu.
English: In addition Flurbiprofen Geiser has a different flavour and contains smaller amounts of substances called cyclodextrins, which help to stabilise the solution.
Croatian: Osim toga, Flurbiprofen Geiser ima drugačiji okus i sadrži manje količine ciklodekstrina, tvari koje pomažu stabilizirati otopinu.
English: What is Flurbiprofen Geiser?
Croatian: Što je Flurbiprofen Geiser?
English: submitted Flurbiprofen Geiser to the Spanish medicines agency for a decentralised procedure.
Croatian: Tvrtka Geiser Pharma S.L. podnijela je lijek Flurbiprofen Geiser španjolskoj agenciji za lijekove radi provedbe decentraliziranog postupka.
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Flurbiprofen Geiser on 16/12/2019.
Croatian: Europska komisija izdala je pravno obvezujuću odluku na razini EU-a o davanju odobrenja za stavljanje u promet lijeka Flurbiprofen Geiser.
English: Name Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik
English: Packaging Content
Croatian: Način primjene Pakovanje
English: Package size Withdrawal Period
Croatian: Veličina pakovanja
English: You will probably need to lie down until you feel better.
Croatian: Vjerojatno ćete trebati ležati neko vrijeme dok se ne budete osjećali bolje.
English: Do not stop your treatment just because you feel better.
Croatian: Nemojte prekidati liječenje samo zato jer se osjećate bolje.
English: There are no adequate and well-controlled studies in pregnant women.
Croatian: Ne postoje odgovarajuća i dobro kontrolirana ispitivanja s trudnicama.
English: As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.
Croatian: Kao rutinsku mjeru opreza, ako ste stariji od 65 godina, Vaš liječnik Vam može kontrolirati krvni tlak.
English: The doctor or nurse may also want to measure your blood pressure and pulse.
Croatian: Liječnik ili medicinska sestra će također možda htjeti izmjeriti Vaš krvni tlak i puls.
English: An updated RMP should be submitted:
Croatian: Ažurirani RMP trebao bi biti dostavljen:
English: This will usually pass on its own but if it does not, tell your doctor.
Croatian: To će obično prestati samo od sebe, ali ako ne prestane, obavijestite svog liječnika.
English: Slowly withdraw the desired amount.
Croatian: 2. Polako navucite potrebnu količinu.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE, AKO JE POTREBNO
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1, ali nije moguće dati preporuke o doziranju.
English: ZYPADHERA can sometimes enter the bloodstream too quickly.
Croatian: ZYPADHERA ponekad može prebrzo ući u krvotok.
English: Consequently, newborns should be monitored carefully.
Croatian: Prema tome, novorođenčad mora biti pažljivo nadzirana.
English: Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Croatian: Obavijestite svog liječnika ako Vi ili netko u Vašoj obitelji ima krvne ugruške u povijesti bolesti, jer su se lijekovi poput ovih povezivali sa stvaranjem krvnih ugrušaka.
English: If you notice any of these symptoms seek medical advice immediately;
Croatian: Ako primijetite bilo koji od ovih simptoma odmah potražite medicinski savjet;
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Croatian: U nekim slučajevima prethodno je bio prijavljen porast tjelesne težine, koji bi mogao biti predisponirajući čimbenik.
English: The injection should be performed with steady, continuous pressure.
Croatian: Lijek treba injicirati uz stalan, kontinuirani pritisak.
English: Information on long term safety is primarily limited to open-label, uncontrolled data.
Croatian: Informacije o dugoročnoj sigurnosti primjene ograničene su prvenstveno na podatke iz otvorenih nekontroliranih ispitivanja.
English: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Croatian: Početnu dozu i raspon doziranja nije potrebno rutinski mijenjati kod nepušača u odnosu na pušače.
English: Cardiovascular monitoring is necessary to detect possible arrhythmias.
Croatian: Kardiovaskularni nadzor je potreban kako bi se uočile moguće aritmije.
English: The absorption and elimination are complete approximately six to eight months after the last injection.
Croatian: Procesi apsorpcije i eliminacije u potpunosti se završe približno 6 do 8 mjeseci nakon zadnje injekcije.
English: It is recommended that blood pressure is measured periodically in patients over 65 years.
Croatian: Preporučuje se redovito mjerenje krvnog tlaka u bolesnika starijih od 65 godina.
English: DO NOT MASSAGE THE INJECTION SITE.
Croatian: NE MASIRATI MJESTO INJICIRANJA.
English: If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Croatian: Ako propustite dobiti injekciju, morate kontaktirati svog liječnika kako bi dogovorili sljedeću injekciju što ranije.
English: Some fatal cases have been reported in this particular group of patients.
Croatian: U ovoj posebnoj skupini bolesnika prijavljeni su neki smrtni slučajevi.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this injection.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovu injekciju.
English: Long-term exposure (at least 48 weeks)
Croatian: Dugotrajna izloženost lijeku (najmanje 48 tjedana)
English: Withdraw air to equalize the pressure in the vial.
Croatian: Izvucite zrak da izjednačite tlak u bočici.
English: Other symptoms may include:
Croatian: . Od ostalih simptoma mogu se javiti:
English: In some cases, these symptoms can lead to unconsciousness.
Croatian: U pojedinim slučajevima ti simptomi mogu dovesti i do gubitka svijesti.
English: For instructions for use, see section 6.6.
Croatian: Za upute o primjeni vidjeti dio 6.6.
English: The release becomes diminishingly smaller within eight to twelve weeks.
Croatian: Oslobađanje polagano slabi unutar 8 do 12 tjedana.
English: It is important to note that there is more solvent in the vial than is needed to reconstitute.
Croatian: Važno je napomenuti da je u bočici više otapala nego što je potrebno za rekonstituciju.
English: These reactions occurred in <0.1% of injections and approximately 2% of patients.
Croatian: Te su nuspojave zabilježene u < 0,1% injekcija i približno 2% bolesnika.
English: Unsuspended: visible clumps Suspended: no clumps Figure B: Check for unsuspended powder and repeat tapping if needed.
Croatian: Nesuspendirano: vidljive grudice Suspendirano: nema grudica Slika B: Provjerite ima li nesuspendiranog praška i ponovite lupkanje ako je potrebno.
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Croatian: Navedeni simptomi se mogu privremeno pogoršati ili čak pojaviti po prestanku liječenja.
English: • increase in blood pressure
Croatian: • povišenje krvnog tlaka
English: In most cases, initial signs and symptoms related to this reaction have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 - 72 hours after injection.
Croatian: većini slučajeva početni znakovi i simptomi vezani uz ove reakcije pojavljivali su se unutar sat vremena od injekcije i u svim slučajevima je došlo do potpunog oporavka unutar 24-72 sata od injekcije.
English: However, the magnitude of the impact of gender, or smoking on olanzapine clearance is small in comparison to the overall variability between individuals.
Croatian: Međutim, raspon utjecaja spola ili pušenja na klirens olanzapina je mali u usporedbi s ukupnom varijabilnošću među pojedincima.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se kod Vaše bebe pojavi bilo koji od ovih simptoma, možda ćete morati kontaktirati svog liječnika.
English: Your doctor will decide how much ZYPADHERA you need and how often you need to be given an injection.
Croatian: Vaš liječnik odlučit će kolika Vam je doza lijeka ZYPADHERA potrebna i koliko često ćete primati injekcije.
English: Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 2025 °C.
Croatian: Kemijska i fizikalna stabilnost suspenzije u bočicama dokazana je do 24 sata na 20-25°C.
English: Patients should be closely monitored during this period.
Croatian: Bolesnike se mora pomno pratiti tijekom ovog razdoblja.
English: A patient card shall be distributed to all patients, including:
Croatian: Kartica za bolesnike dat će se svim bolesnicima, i uključivat će:
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Croatian: Medijan letalnih doza bio je otprilike 210 mg/kg (miševi) i 175 mg/kg (štakori).
English: During treatment dose may subsequently be adjusted on the basis of individual clinical status.
Croatian: Tijekom liječenja dozu se zatim može prilagođavati na temelju kliničkog stanja pojedinog bolesnika.
English: Do not use this product if you notice discolouration or other visible signs of deterioration.
Croatian: Nemojte primijeniti ovaj lijek ako primijetite promjenu boje ili neki drugi vidljiv znak propadanja.
English: People with this disease may also feel depressed, anxious or tense.
Croatian: Bolesnici koji boluju od ove bolesti mogu također osjećati depresiju, tjeskobu ili napetost.
English: These events occurred in about 0.1 to 1.1% of patients.
Croatian: Ove nuspojave uočene su u približno 0,1 do 1,1% bolesnika.
English: This leaflet was last revised in {mmm YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {mmm GGGG}
English: The majority of these reactions was reported to be of “mild” to “moderate” severity.
Croatian: Većina tih nuspojava prijavljene su kao “blage” do “umjerene” prema svojoj težini.
English: Due to biochemical and physiological modification and reduction of muscular mass, this formulation is not recommended to be started in this sub-group of patients.
Croatian: Zbog biokemijskih i fizioloških promjena te smanjenja mišićne mase, ne preporučuje se započeti liječenje navedene podskupine bolesnika ovom formulacijom.
English: Determine which needle will be used to administer the injection to the patient.
Croatian: Odredite koja igla će biti korištena za davanje injekcije bolesniku.
English: Neuroleptic Malignant Syndrome (NMS)
Croatian: Maligni neuroleptički sindrom (MNS)
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Croatian: 16 Povišene vrijednosti prolaktina u plazmi prijavljene su u 47,4% adolescentnih bolesnika.
English: Date of latest renewal: 26/08/2013
Croatian: Datum posljednje obnove odobrenja: 26.8.2013.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signficant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).