FrancophonIA/ELRC3.0 huggingface dataset:
English: The complete response rate was 5.5% for talazoparib compared to 0% for the chemotherapy arm. e. Per RECIST 1.1, confirmation of CR/PR was not required.
Croatian: Ukupna stopa odgovora iznosila je 5,5 % za talazoparib u usporedbi s 0 % za skupinu liječenu kemoterapijom.
English: Effect of acid-reducing agents
Croatian: Učinak lijekova koji smanjuju kiselinu
English: Events, number (%) Median (95% CI), months Hazard ratioa (95% CI) 2-sided p-valueb p<0.0001
Croatian: Događaji, broj (%) Medijan (95 % CI), mjeseci Omjer hazarda a (95 % CI) p-vrijednost dvostranog testa p < 0,0001
English: Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy) during treatment with Talzenna, and for at least 4 months after the final dose (see section 4.4).
Croatian: Muške bolesnike koji imaju partnerice reproduktivne dobi ili trudne partnerice treba savjetovati da koriste učinkovitu kontracepciju (čak i nakon vazektomije) tijekom liječenja lijekom Talzenna te najmanje 4 mjeseca nakon zadnje doze (vidjeti dio 4.4).
English: How to take Talzenna
Croatian: Kako uzimati lijek Talzenna
English: 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Croatian: Ovojnica kapsule od 1 mg hipromeloza (HPMC) crveni željezov oksid (E172) žuti željezov oksid (E172) titanijev dioksid (E171)
English: Dose modification and management Withhold Talzenna until levels resolve to
Croatian: Ne uzimajte lijek Talzenna dok se razine ne vrate na
English: Carbamazepine and phenytoin - anti-epileptics used to treat seizures or fits.
Croatian: Sljedeći lijekovi mogu smanjiti učinak lijeka Talzenna: - Karbamazepin i fenitoin - antiepileptici koji se koriste u liječenju epileptičkih ili drugih napadaja.
English: 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
Croatian: Ovojnica kapsule od 0,25 mg hipromeloza (HPMC) žuti željezov oksid (E172) titanijev dioksid (E171)
English: e. Includes preferred terms of lymphocyte count decreased and lymphopenia.
Croatian: Uključuje preporučene pojmove: smanjen broj limfocita i limfopenija.
English: How to store Talzenna
Croatian: Kako čuvati lijek Talzenna
English: Men with female partners who are pregnant or able to become pregnant should use effective birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.
Croatian: Muškarci koji imaju partnerice koje su trudne ili mogu zatrudnjeti moraju koristiti učinkovitu metodu protiv začeća (kontracepciju) , čak i nakon vazektomije, tijekom liječenja lijekom Talzenna te najmanje 4 mjeseca nakon zadnje doze.
English: However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Croatian: P-gp-a na izloženost talazoparibu nije ispitivana.
English: Talzenna 0.25 mg hard capsules
Croatian: Talzenna 0,25 mg tvrde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: ECOG performance status, n (%)
Croatian: Funkcionalni status prema Istočnoj kooperativnoj onkološkoj skupini (ECOG), n (%)
English: Talzenna contains the active substance talazoparib.
Croatian: Što Talzenna sadrži - Djelatna tvar je talazoparib.
English: Gender, n (%)
Croatian: Spol, n (%)
English: All grades* n (%)
Croatian: Svi stupnjevi n (%)
English: For patients with moderate renal impairment (30 mL/min ≤ CrCl < 60 mL/min), the recommended starting dose of Talzenna is 0.75 mg once daily.
Croatian: Preporučena početna doza lijeka Talzenna je 0,75 mg jednom na dan za bolesnike s umjerenim oštećenjem bubrega (30 ml/min ≤ CrCl < 60 ml/min).
English: Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8).
Croatian: U bolesnika liječenih talazoparibom prijavljena je mijelosupresija koja uključuje anemiju, leukopeniju/neutropeniju i/ili trombocitopeniju (vidjeti dio 4.8).
English: Other
Croatian: Druga
English: Red iron oxide (E172)
Croatian: (E171) i crveni željezov oksid (E172)
English: Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib
Croatian: Talzenna 0,25 mg tvrde kapsule Talzenna 1 mg tvrde kapsule talazoparib
English: Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy), during treatment with Talzenna and for at least 4 months after the final dose.
Croatian: Muške bolesnike koji imaju partnerice reproduktivne dobi ili trudne partnerice treba savjetovati da koriste učinkovitu kontracepciju (čak i nakon vazektomije) tijekom liječenja lijekom Talzenna te najmanje 4 mjeseca nakon zadnje doze.
English: BRCA2-mutation positive
Croatian: Status mutacije gena
English: (stratification factors: number of prior cytotoxic chemotherapy regimens, triple-negative status, history of central nervous system metastasis) and was relative to overall chemotherapy with < 1 favouring talazoparib.
Croatian: Omjer hazarda temeljen je na stratificiranom Coxovom regresijskom modelu s liječenjem kao jedinom kovarijablom (čimbenici stratifikacije: broj prethodnih režima citotoksične kemoterapije, trostruko negativan status, metastaza u središnjem živčanom sustavu u anamnezi) i uspoređen s ukupnom kemoterapijom s < 1 u korist talazopariba.
English: (total bilirubin > 1.5 to 3.0 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3.0 × ULN and any AST) (see section 5.2).
Croatian: Lijek Talzenna nije ispitivan u bolesnika s umjerenim (ukupni bilirubin > 1,5 do 3,0 × GGN i bilo koji AST) ili teškim oštećenjem jetre (ukupni bilirubin > 3,0 × GGN i bilo koji AST) (vidjeti dio 5.2).
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules
Croatian: Talzenna 0,25 mg tvrde kapsule Talzenna 1 mg tvrde kapsule
English: Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Croatian: - Tvrde kapsule Talzenna od 1 mg: jedna kapsula sadrži 1 mg talazopariba u obliku talazoparib tosilata.
English: Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Croatian: - Tvrde kapsule Talzenna od 0,25 mg: jedna kapsula sadrži 0,25 mg talazopariba u obliku talazoparib tosilata.
English: Following a single oral dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 4 hours, while the AUCinf was not affected.
Croatian: srednja vrijednost Cmax talazopariba smanjila se za približno 46 %, medijan Tmax odgođen je s 1 na 4 sata, dok AUCinf nije bio promijenjen.
English: Time (Month)
Croatian: Trajanje PFS-a (u mjesecima)
English: Strong inhibitors of P-gp may lead to increased talazoparib exposure.
Croatian: Istodobno liječenje inhibitorima P-glikoproteina (P-gp) Jaki inhibitori P-gp-a mogu uzrokovati povećanu izloženost talazoparibu.
English: P-gp is likely involved in talazoparib active renal secretion.
Croatian: Vjerojatno je da je P-gp uključen u aktivnu bubrežnu sekreciju talazopariba.
English: Dysgeusia
Croatian: Dispepsija
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules talazoparib
Croatian: Talzenna 0,25 mg tvrde kapsule talazoparib
English: Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Croatian: Jedna tvrda kapsula sadrži 1 mg talazopariba u obliku talazoparib tosilata.
English: Dizziness Headache
Croatian: - Upala usne šupljine
English: Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Croatian: Talzenna od 1 mg isporučuju se kao neprozirne, tvrde kapsule približnih dimenzija 14,30 mm x 5,32 mm sa svijetlocrvenom kapicom (s otisnutim „Pfizer“ u crnoj boji) i bijelim tijelom (s otisnutim „TLZ 1” u crnoj boji).
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg capsules talazoparib
Croatian: Talzenna 0,25 mg kapsule talazoparib
English: What Talzenna looks like and contents of the pack Talzenna 0.25 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules, with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Croatian: Talzenna od 0,25 mg isporučuju se kao neprozirne, tvrde kapsule približnih dimenzija 14,30 mm x 5,32 mm sa kapicom boje bjelokosti (s otisnutim „Pfizer“ u crnoj boji) i bijelim tijelom (s otisnutim „TLZ 0,25” u crnoj boji).
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg hard capsules talazoparib
Croatian: Talzenna 1 mg tvrde kapsule talazoparib
English: Very common (may affect more than 1 in 10 people) Low counts of white blood cells, red blood cells, and blood platelets Decreased appetite
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Nizak broj leukocita, eritrocita i trombocita - Smanjen apetit - Osjećaj vrtoglavice - Glavobolja - Mučnina - Povraćanje - Proljev - Bol u trbuhu - Gubitak kose
English: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Croatian: Jedna tvrda kapsula sadrži 0,25 mg talazopariba u obliku talazoparib tosilata.
English: Of the 431 patients randomised onto EMBRACA, 287 were randomised to the Talzenna arm and 144 to the chemotherapy arm. Randomisation was stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non-TNBC), and history of central nervous system metastasis (yes versus no).
Croatian: Randomizacija je bila stratificirana prema prethodnoj primjeni kemoterapije za metastatsku bolest (0 naspram 1, 2 ili 3), prema trostruko negativnom statusu bolesti (trostruko negativan rak dojke u odnosu na rak dojke koji nije trostruko negativan) i metastazi u središnjem živčanom sustavu u anamnezi (da naspram ne).
English: a. Includes preferred terms of thrombocytopenia and platelet count decreased.
Croatian: Uključuje preporučene pojmove: trombocitopenija i smanjen broj trombocita.
English: Neutrophil count < 1,000/μL ≥ 1,500/µL Non-haematologic adverse reaction Grade 3 or Grade 4
Croatian: Broj neutrofila < 1000/μl
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/005 (30 hard capsules)
Croatian: EU/1/19/1377/005 (30 tvrdih kapsula)
English: Stomatitis Dyspepsia
Croatian: Prijavljivanje nuspojava
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Croatian: Neprozirne tvrde kapsule približnih dimenzija 14,30 mm x 5,32 mm sa svijetlocrvenom kapicom (s otisnutim „Pfizer“ u crnoj boji) i bijelim tijelom (s otisnutim „TLZ 1“ u crnoj boji).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/006 (30 hard capsules)
Croatian: EU/1/19/1377/006 (30 tvrdih kapsula)
English: Demographic, baseline, and disease characteristics - EMBRACA study Talazoparib
Croatian: Tablica 4. Demografske karakteristike, početne karakteristike i karakteristike bolestiispitivanje EMBRACA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/001 (30 hard capsules)
Croatian: EU/1/19/1377/001 (30 tvrdih kapsula)
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Croatian: Neprozirne tvrde kapsule približnih dimenzija 14,30 mm x 5,32 mm sa kapicom boje bjelokosti (s otisnutim „Pfizer“ u crnoj boji) i bijelim tijelom (s otisnutim „TLZ 0,25” u crnoj boji).
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Croatian: Nisu zabilježene nuspojave stupnja 5.
English: Thrombocytopeniaa Anaemiab Neutropeniac Leucopeniad
Croatian: TNBC temeljen na najnovijoj biopsiji
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg capsules talazoparib
Croatian: Talzenna 1 mg kapsule talazoparib
English: Hormone receptor-positive (ER positive or
Croatian: Svi randomizirani bolesnici (ITT) Status hormonskih receptora
English: In 6 female patients given a single oral dose of [14C]talazoparib, a mean of 69% (±8.6%) and 20%
Croatian: C]talazopariba pronađena je srednja vrijednost od 69 % (± 8,6 %), odnosno 20 % (± 5,5 %) ukupne primijenjene radioaktivne doze u urinu i stolici.
English: Pain in the abdomen
Croatian: Bol u trbuhu
English: 90 × 1 capsules
Croatian: Tvrda kapsula 30 × 1 kapsula 60 × 1 kapsula 90 × 1 kapsula
English: TABLET
Croatian: TABLETA
English: Annex I List of nationally authorised medicinal products
Croatian: Prilog I Popis nacionalno odobrenih lijekova
English: United Kingdom SoliCol D3
Croatian: Solicol D3
English: Member State in EU/EEA
Croatian: Država članica u EU/EGP
English: COLECALCIFEROL 20,000 IU
Croatian: Kolecalciferol 20.000 IU
English: Annex IC - SoliCol D3 Member State in EU/EEA
Croatian: Prilog IC- SoliCol D3 Država članica u EU/EGP
English: COLECALCIFEROL 50,000 IU
Croatian: Kolekalciferol 50.000 IU
English: Ferring Hellas Mepe Progesterone
Croatian: Ferring Hellas Mepe Progesteron
English: EU/EEA
Croatian: EU/EGP
English: Annex IB - Dutasteride Actavis and associated names Member State in
Croatian: Prilog IB- Dutasteride Actavis i pridruženi nazivi Država članica u
English: Ferring Legemidler As Progesterone
Croatian: Ferring Legemidler As Progesteron
English: United Kingdom Dutasteride Actavis Group
Croatian: Dutasteride Actavis Group
English: Ferring Läkemedel Ab Progesterone
Croatian: Ferring Läkemedel Ab Progesteron
English: Ferring Lääkkeet Oy Progesterone
Croatian: Ferring Lääkkeet Oy Progesteron
English: Annex IA - Lutinus and associated names Member State in
Croatian: Prilog IA- Lutinus i pridruženi nazivi Država članica u EU/EGP
English: United Kingdom Lutigest
Croatian: Republika Češka Lutinus
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakiranje Veličina pakiranja
English: 5 February 2016
Croatian: 5. veljače 2016
English: How to contact the Agency
Croatian: Kontaktirajte Agenciju
English: This information will be used to support regulatory business activities, including:
Croatian: Ove informacije primjenjivat će se u prilog regulatornih poslovnih aktivnosti, uključujući:
English: Legal Requirements
Croatian: Zakonska obveza
English: Article 57 (2) of Regulation (EC) No 726/2004
Croatian: Članak 57. stavka 2. Uredbe (EZ) br. 726/2004
English: EMA/736031/2014, Rev. 1 Information Management
Croatian: EMA/783810/2014, Rev.
English: How to submit: Registration & Training
Croatian: Kako se dostavlja: registracija i obuka
English: To ensure the quality of data submitted to the EudraVigilance database, at least one user from each organisation should receive training.
Croatian: Da bi se osigurala kvaliteta podataka dostavljenih u bazu podataka EudraVigilance, najmanje jedan korisnik iz svake organizacije mora proći obuku.
English: What to submit: Information on medicinal products
Croatian: Što se dostavlja: informacije o medicinskim proizvodima
English: Marketing-authorisation holders were initially required to submit information on medicinal products for human use by 2 July 2012.
Croatian: Prvotno su nositelji odobrenja za stavljanje lijeka u promet bili dužni dostaviti informacije o lijekovima za ljudsku uporabu do 2. srpnja 2012.
English: Why submit: Scope
Croatian: Zašto dostaviti: područje primjene
English: This is to ensure that privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.
Croatian: Registracija je potrebna kako bi se osigurala privatnost, provođenje sigurnosnih mjera te poštivanje načela cjelovitosti, odgovornosti i dostupnosti podataka.
English: • strengthening transparency and communication with the Agency's stakeholders by establishing the European medicines web portal, granting access to safety data, efficiently exchanging data within the EU Network and international partners, and supporting communication between the Agency's Committees and pharmaceutical industry.
Croatian: • ojacavanje transparentnosti i komunikacije sa zastupnicima interesnih skupina pri Agenciji uspostavljanjem europskog Internet portala za lijekove, odobravajući pristup podacima o sigurnoj primjeni, uspostavljanjem učinkovite razmjene podataka unutar EU mreže i međunarodnih partnera, kao i podržavanjem komunikacije između povjerenstava pri Agenciji i farmaceutske industrije.
English: When to submit
Croatian: Kada se podaci dostavljaju
English: • coding of substance and product information reported in Individual Case Safety Reports (ICSRs) within the Eudravigilance system to support Pharmacovigilance signal management activities and the performance of data analysis and business intelligence at the Agency;
Croatian: • kodiranje tvari i informacija o proizvodu prijavljenih u Sigurnosnim izvješćima o pojedinačnom slučaju (ICSR-ovima) u sklopu sustava Eudravigilance kao podrska aktivnostima u upravljanju signalima u farmakovigilancijii ucinkovitosti analize podataka i poslovne inteligencije u Agenciji;
English: • facilitating the coordination of regulatory decisions and actions to safeguard public health, e.g. to support referral procedures, the establishment of a repository of Periodic Safety Update Reports (PSURs) and literature monitoring;
Croatian: • omogućavanje koordinacije regulatornih odluka i radnji za očuvanje javnoga zdravlja, primjerice kao podrska arbitraznim postupcima, uspostavljanja repozitorija za periodička izvješća o neškodljivosti lijeka (PSUR-ove) i praćenje literature;
English: The submission of medicinal product data by marketing-authorisation holders (MAHs) is a legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.
Croatian: Dostavljanje podataka o lijekovima od strane nositelja odobrenja za stavljanje lijeka u promet (nositelja odobrenja) je zakonska obveza uvedena člankom 57. stavkom 2. Uredbe (EZ) br. 726/2004.
English: • calculating the Pharmacovigilance Fees payable by MAHs;
Croatian: • izračunavanje farmakovigilancijskih pristojbi koje trebaju platiti nositelji odobrenja;
English: For enquiries related to the EU SME definition please contact the SME office (sme@ema.europa.eu).
Croatian: U slučaju pitanja vezanih za definiciju malih i srednjih poduzeća u EU-u, molimo kontaktirajte ured za mala i srednja poduzeća (sme@ema.europa.eu).
English: To begin data submission of authorised medicinal products, marketing-authorisation holders need to register with Eudravigilance.
Croatian: Da bi se započeo postupak dostavljanja podataka za odobrene lijekove, nositelji odobrenja trebaju se registrirati pri sustavu Eudravigilance.
English: • nationally authorised medicinal products;
Croatian: • nacionalno odobrene lijekove;
English: The aim of the data submission is to establish a complete inventory of all medicines authorised for human use in the EEA, including medicines authorised centrally via the EMA and those authorised at national level via the National Competent Authorities (NCAs).
Croatian: Svrha dostavljanja podataka jest utvrditi potpuni inventar svih lijekova odobrenih za humanu uporabu u EGP-u, uključujući i lijekove koji su središnje odobreni putem EMA-e kao i one odobrene na nacionalnoj razini putem nacionalnih nadležnih tijela (NCA-ova).
English: For enquires on how to register contact the Eudravigilance registration office (eudravigilanceregistration@ema.europa.eu).
Croatian: U slučaju pitanja vezanih za način registriranja, kontaktirajte Eudravigilance - ured za registraciju (eudravigilanceregistration@ema.europa.eu).
English: This legal provision requires all holders of marketing authorisations for medicinal products for human use in the European Economic Area (EEA) to submit information to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format.
Croatian: Ova zakonska odredba zahtijeva od svih nositelja odobrenja za stavljanje lijeka u promet za lijekove za humanu uporabu na razini Europskog gospodarskog područja (EGP) da dostave informacije Europskoj agenciji za lijekove (EMA) primjenom elektronskog formata navedenog u članku 57. ili formata Proširenog izvješća o lijeku za unošenje nuspojava u EudraVigilance bazu podataka (XEVPRM).
English: Since July 2012, MAHs are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the NCA.
Croatian: Od srpnja 2012., nositelji odobrenja dužni su dostaviti informacije o novim odobrenjima za stavljanje lijeka u promet izdanima nakon srpnja 2012. u roku od 15 kalendarskih dana od datuma primitka obavijesti kojom se odobrava izdavanje odobrenja za stavljanje lijeka u promet od strane nacionalnog nadležnog tijela.
English: • medicinal products authorised through the mutual recognition procedure;
Croatian: • lijekove odobrene putem postupka međusobnog priznavanja;
English: • medicinal products authorised through the decentralised procedure.
Croatian: • lijekove odobrene putem decentraliziranog postupka.
English: By 31 December 2014 MAHs were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additional information in line with the guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Croatian: Do 31. prosinca 2014. nositelji odobrenja također su bili dužni poboljšati kvalitetu informacija o odobrenim lijekovima dostavljenima EMA-i, ažurirajući svoje unose o lijekovima i dostavljajući dodatne informacije u skladu sa smjernicama i postupcima opisanima u Poglavlju 3.II.: Smjernice za korisnike proširenog izvješća o lijeku za unošenje nuspojava u bazu podataka EudraVigilance (XEVPRM).
English: Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised as per guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Croatian: Informacije o dopunama uvjeta odobrenja za stavljanje lijeka u promet, nakon izmjene, prijenosa, obnove, suspenzije, opoziva ili povlačenja imaju se dostaviti EMA-i najkasnije 30 kalendarskih dana od datuma odobrenja dopuna u skladu sa smjernicama i postupcima opisanima u Poglavlju 3.II.: Smjernice za korisnike proširenog izvješća o lijeku za unošenje nuspojava u bazu podataka EudraVigilance (XEVPRM).
English: For information related to submission of authorised medicines data visit the Data submission webpage.
Croatian: Za informacije povezane s dostavljanjem podataka za odobrene lijekove posjetite internetsku stranicu za dostavljanje podataka.
English: MAHs are required to submit to the EMA information on all medicinal products for which they hold a marketing authorisation in the EEA, i.e.:
Croatian: Nositelji odobrenja dužni su dostaviti informacije EMA-i vezane uz sve lijekove za koje imaju odobrenje za stavljanje u lijeka u promet na području EEA, odnosno:
English: An eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course is available as a face-to-face or e-learning training course.
Croatian: Tečaj obuke za prošireni rječnik za unošenje nuspojava u bazu podataka EudraVigilance (skraćeno: XEVMPD) dostupan je uživo ili kao e-učilica (online tečaj).
English: Enquiries related to Article 57(2) submissions can be submitted to the EMA via the EMA Service Desk portal (https://servicedesk.ema.europa.eu).
Croatian: Upiti vezani uz slanje informacija o registriranim medicinskim proizodima u skladu sa Člankom 57(2) mogu se poslati EMA-i putem EMA Service Desk portala (https://servicedesk.ema.europa.eu).