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.
Danish: Den samlede responsrate var 5,5 % for talazoparib sammenlignet med 0 % for kemoterapiarmen.
English: b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased.
Danish: Omfatter de foretrukne termer for anæmi, nedsat hæmatokrit og nedsat hæmoglobin.
English: Events, number (%) Median (95% CI), months Hazard ratioa (95% CI) 2-sided p-valueb p<0.0001
Danish: Hændelser, antal (%) Median (95 % CI), måneder Hazard ratio a (95 % CI) 2-sidet p-værdi p < 0,0001
English: The PK of talazoparib have not been studied in patients with moderate (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 4.2).
Danish: Farmakokinetikken for talazoparaib er ikke undersøgt for patienter med moderat (total bilirubin > 1,5-3,0 × ULN og evt. ASAT) eller svært nedsat leverfunktion (total bilirubin > 3,0 × ULN og evt. ASAT) (se pkt.
English: Talzenna is not recommended for use in patients with severe renal impairment or requiring haemodialysis (see section 5.2).
Danish: Det anbefales ikke at bruge Talzenna til patienter med kraftigt nedsat nyrefunktion eller med behov for hæmodialyse (se pkt.
English: 0.5 mg (two 0.25 mg capsules) once daily
Danish: 0,5 mg (to 0,25 mg kapsler) 1 gang dagligt
English: Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo micronucleus assay in rats at exposures similar to clinically relevant doses.
Danish: Talazoparib var clastogent i en in vitro-kromosomaberrationsanalyse i humane, perifere blodlymfocytter og i en in vivomikronukleusanalyse af rotter ved en eksponering svarende til klinisk relevante doser.
English: 0.25 mg (one 0.25 mg capsule) once daily Complete blood count should be obtained prior to starting Talzenna therapy and monitored monthly and as clinically indicated (see Table 2 and section 4.4).
Danish: Inden behandlingsstart med Talzenna skal der foretages en komplet blodtælling, og der skal monitoreres månedligt og i henhold til den kliniske indikation (se tabel 2 og pkt.
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.
Danish: Mandlige patienter med kvindelige fertile partnere eller gravide partnere skal rådes til at anvende sikker kontraception (selv efter vasektomi) under behandlingen med Talzenna og i mindst 4 måneder efter sidste dosis.
English: Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib
Danish: Talzenna 0,25 mg hårde kapsler Talzenna 1 mg hårde kapsler talazoparib
English: Contraception in women of childbearing potential
Danish: Kontraception til fertile kvinder
English: Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman.
Danish: Talazoparib var clastogent i en in vitro-kromosomskade-analyse af humane, perifere blodlymfocytter og i en in vivo-knoglemarvsmikronukleus-analyse af rotter, men ikke mutagent i Ames-test (se pkt.
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
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer) - lavt antal hvide blodlegemer, røde blodlegemer og blodplader - nedsat appetit - svimmelhed - hovedpine - kvalme - kaste op - diarré - smerter i mave/underliv - hårtab
English: In 6 female patients given a single oral dose of [14C]talazoparib, a mean of 69% (±8.6%) and 20%
Danish: For 6 kvindelige patienter, der fik en enkelt oral dosis C)talazoparib, blev i gennemsnit 69 % (±8,6%) og 20% (±5,5%) af den samlede radioaktive dosis, der blev administreret, fundet i henholdsvis urin og fæces.
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).
Danish: Mandlige patienter med kvindelige fertile partnere eller gravide partnere skal rådes til at anvende sikker kontraception (selv efter vasektomi) under behandlingen med Talzenna og i mindst 4 måneder efter sidste dosis (se pkt.
English: Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells.
Danish: Talzenna blokerer et enzym, der reparerer beskadiget DNA i kræftcellerne, så kræftcellerne ikke kan reparere sig selv og dermed dør.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Meget almindelig Alopeci
English: Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Danish: - Talzenna 0,25 mg hårde kapsler: hver kapsel indeholder talazoparibtosylat svarende til 0,25 mg talazoparib.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Headache
Danish: Kvalme
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).
Danish: Randomiseringen blev stratificeret ud fra forudgående brug af kemoterapi mod metastatisk sygdom (0 vs. 1, 2 eller 3), triple negativ sygdomsstatus (triple negativ brystkræft (TNBC) sammenlignet med ikke-TNBC) samt metastaser i centralnervesystemet i anamnesen (ja vs. nej).
English: A risk to breast-fed children cannot be excluded and therefore breast-feeding is not recommended during treatment with Talzenna and for at least 1 month after the final dose.
Danish: Derfor anbefales amning ikke under behandling med Talzenna og i mindst 1 måned efter den sidste dosis.
English: Do not open, crush or chew the capsules.
Danish: Kapslerne må ikke åbnes, knuses eller tygges.
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.
Danish: Hazard ratio var baseret på en stratificeret Cox-regressionsmodel med behandling som eneste kovariant (stratificeringsfaktorer: antal forudgående behandlinger med cytotoksisk kemoterapi, triple-negative-status, CNS metastaser i anamnesen) og var i forhold til samlet kemoterapi med < 1 til fordel for talazoparib.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg capsules talazoparib
Danish: Talzenna 0,25 mg kapsler talazoparib
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).
Danish: Talzenna 1 mg leveres som uigennemsigtige ca. 14,30 mm x 5,32 mm hårde kapsler med svagt rød overdel (påtrykt ”Pfizer” med sort skrift) og hvid underdel (påtrykt ”TLZ 1” med sorte skrift).
English: 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Danish: - 0,25 mg kapselskal: Hypromellose (HPMC), gul jernoxid (E172) og titandioxid (E171) - 1 mg kapselskal: Hypromellose (HPMC), gul jernoxid (E172), titandioxid (E171) og rød jernoxid (E172)
English: Diarrhoea
Danish: Dyspepsi
English: Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Danish: Hver hård kapsel indeholder talazoparib-tosylat svarende til 1 mg talazoparib.
English: BCRP inhibitors
Danish: BCRP-hæmmere
English: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Danish: Hver hård kapsel indeholder talazoparib-tosylat svarende til 0,25 mg talazoparib.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg capsules talazoparib
Danish: Talzenna 1 mg kapsler talazoparib
English: Neutrophil count < 1,000/μL ≥ 1,500/µL Non-haematologic adverse reaction Grade 3 or Grade 4
Danish: Non-hæmatologiske bivirkninger grad 3 eller 4.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules
Danish: Talzenna 0,25 mg hårde kapsler Talzenna 1 mg hårde kapsler
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed
English: Resume Talzenna
Danish: Genoptag Talzenna
English: Anaemia: Being short of breath, feeling very tired, pale skin, or fast heartbeat - these may be signs of a low red blood cell count
Danish: Du skal være opmærksom på følgende symptomer: - Blodmangel (anæmi): være forpustet, føle sig træt, bleg hud eller hurtig hjerterytme - det kan være tegn på et lavt antal røde blodlegemer.
English: Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Danish: - Talzenna 1 mg hårde kapsler: hver kapsel indeholder talazoparibtosylat svarende til 1 mg talazoparib.
English: Co-administration should only be considered after careful evaluation of the potential benefits and risks.
Danish: Overvej fordele og risici nøje inden samtidig administration.
English: Strong inhibitors of P-gp may lead to increased talazoparib exposure.
Danish: Samtidig behandling med P-glykoprotein-hæmmere (P-gp) Kraftige P-glykoprotein-hæmmere kan føre til øget eksponering for 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).
Danish: Talzenna 0,25 mg leveres som uigennemsigtige ca. 14,30 mm x 5,32 mm hårde kapsler med elfenbensfarvet overdel (påtrykt ”Pfizer” med sort skrift) og hvid underdel (påtrykt ”TLZ 0.25” med sorte skrift).
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.
Danish: Mænd med en kvindelig partner, der er gravid eller kan blive det, skal bruge en sikker form for prævention, også efter sterilisering af manden, mens de bliver behandlet med Talzenna og i mindst 4 måneder efter sidste dosis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER OUTER CARTON
Danish: BLISTER YDRE KARTON
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/005 (30 hard capsules)
Danish: EU/1/19/1377/005 (30 hårde kapsler)
English: 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
Danish: Hypromellose (HPMC) Gul jernoxid (E172) Titandioxid (E171)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/006 (30 hard capsules)
Danish: EU/1/19/1377/006 (30 hårde kapsler)
English: Vomiting Diarrhoea Nausea
Danish: Mave-tarm-kanalen Meget almindelig Opkastning Diarré
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).
Danish: Uigennemsigtig ca. 14,30 mm x 5,32 mm hård kapsel med elfenbensfarvet overdel (påtrykt ”Pfizer” med sort skrift) og hvid underdel (påtrykt ”TLZ 0.25” med sort skrift).
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).
Danish: Uigennemsigtig ca. 14,30 mm x 5,32 mm hård kapsel med svagt rød overdel (påtrykt ”Pfizer” med sort skrift) og hvid underdel (påtrykt ”TLZ 1” med sort skrift).
English: Carbamazepine and phenytoin - anti-epileptics used to treat seizures or fits.
Danish: Følgende lægemidler kan nedsætte virkningen af Talzenna: - Carbamazepin og phenytoin, epilepsimidler til behandling af anfald.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules talazoparib
Danish: Talzenna 0,25 mg hårde kapsler talazoparib
English: How to take Talzenna
Danish: Sådan skal du tage Talzenna
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg hard capsules talazoparib
Danish: Talzenna 1 mg hårde kapsler talazoparib
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).
Danish: Talzenna er ikke blevet undersøgt hos patienter med moderat (total bilirubin > 1,5-3,0 × ULN og enhver ASAT) eller kraftigt nedsat leverfunktion (total bilirubin > 3,0 × ULN og enhver ASAT) (se pkt.
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.
Danish: For patienter med moderat nedsat nyrefunktion (30 ml/min.
English: Hepatic impairment
Danish: Abdominalsmerter Almindelig Stomatitis
English: Stomatitis Dyspepsia
Danish: Nedsat nyrefunktion
English: Feeling sick (nausea)
Danish: Amning (se pkt.
English: Based on a population PK analysis that included 490 patients, where 132 patients had mild renal impairment (60 mL/min ≤ CrCL < 90 mL/min), 33 patients had moderate renal impairment (30 mL/min ≤ CrCL < 60 mL/min), and 1 patient had severe renal impairment (CrCL < 30 mL/min), talazoparib CL/F was decreased by 14% and 37% in patients with mild and moderate renal impairment, respectively, when compared to patients with normal renal function (CrCL ≥ 90 mL/min).
Danish: ), faldt CL/F for talazoparib med henholdsvis 14 % og 37 % hos patienter med let til moderat nedsat nyrefunktion sammenlignet med patienter med normalt nyrefunktion (CrCL ≥ 90 ml/min.).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Danish: Hver enkelt kapsel indeholder talazoparib-tosylat svarende til 1 mg talazoparib.
English: Repeat-dose toxicity
Danish: Toksicitetsstudier
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/001 (30 hard capsules)
Danish: EU/1/19/1377/001 30 hårde kapsler
English: United Kingdom SoliCol D3
Danish: Storbritannien Solicol D3
English: Member State in EU/EEA
Danish: Medlemsland I EU/EØS
English: United Kingdom Lutigest
Danish: Storbritannien Lutigest
English: Annex IC - SoliCol D3 Member State in EU/EEA
Danish: Bilag IC - SoliCol D3 Medlemsland I EU/EØS
English: United Kingdom Dutasteride Actavis Group
Danish: Storbritannien Dutasteride Actavis Group
English: Annex IA - Lutinus and associated names Member State in
Danish: Bilag IA -Lutinus og tilhørende navne Medlemsland I
English: Ferring Magyarország Gyógyszerkereskedel mi Kft.
Danish: Ferring Magyarország Gyógyszerkereskedelmi Kft.
English: ORAL USE
Danish: ORAL BRUG
English: Annex IB - Dutasteride Actavis and associated names Member State in
Danish: Bilag IB - Dutasteride Actavis og tilhørende navne Medlemsland I
English: EU/EEA
Danish: EU/EØS
English: Ferring Legemidler As Progesterone
Danish: Ferring Legemidler As Progesteron
English: COLECALCIFEROL 20,000 IU
Danish: Cholecalciferol 20,000 IE
English: COLECALCIFEROL 50,000 IU
Danish: Cholecalciferol 50,000 IE
English: Ferring Läkemedel Ab Progesterone
Danish: Ferring Läkemedel Ab Progesteron
English: Ferring Lægemidler A/S
Danish: Ferring Lægemidler A/S Progesteron
English: Ferring Hellas Mepe Progesterone
Danish: Ferring Hellas Mepe
English: Ferring Lääkkeet Oy Progesterone
Danish: Ferring Lääkkeet Oy
English: Unipessoal, Lda.
Danish: Ferring PortuguesaProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
English: 5 February 2016
Danish: 5. februar 2016
English: How to contact the Agency
Danish: Hvordan man kontakter agenturet
English: Article 57 (2) of Regulation (EC) No 726/2004
Danish: Artikel 57, stk. 2, i forordning (EF) nr. 726/2004
English: Legal Requirements
Danish: Lovkrav
English: This information will be used to support regulatory business activities, including:
Danish: Disse oplysninger vil blive anvendt til myndighedernes regulerende aktiviteter, herunder:
English: When to submit
Danish: Hvornår man skal indsende
English: What to submit: Information on medicinal products
Danish: Hvad man skal indsende: Oplysninger om lægemidler
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.
Danish: Indsendelse af oplysninger om lægemidler fra indehaverne af markedsføringstilladelser er et lovkrav, der blev indført med artikel 57, stk. 2 i forordning (EF) nr. 726/2004.
English: Marketing-authorisation holders were initially required to submit information on medicinal products for human use by 2 July 2012.
Danish: Oprindeligt skulle indehavere af markedsføringstilladelser indsende oplysninger om humanmedicinske lægemidler senest den 2. juli 2012.
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).
Danish: Forespørgsler vedrørende artikel 57(2) kan sendes til EMA via EMA Service Desk portalen (https://servicedesk.ema.europa.eu).
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.
Danish: • styrkelse af gennemsigtighed og kommunikation over for agenturets interessenter ved oprettelse af den europæiske webportal om lægemidler, give adgang til sikkerhedsdata, effektiv dataudveksling med partnere i EU netværket og internationale partnere, og styrkelse af kommunikationen mellem agenturets udvalg og medicinalindustrien.
English: How to submit: Registration & Training
Danish: Hvordan man indsender: Virksomhedsregistrering og kursus
English: Electronic submission of medicinal product information by marketing-authorisation holders
Danish: Elektronisk indsendelse af oplysninger om lægemidler fra indehaverne af markedsføringstilladelser
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.
Danish: Dette er både for at sikre fortroligheden og sikkerheden, og at principperne om dataintegritet, -reviderbarhed og -adgang overholdes.
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;
Danish: • fremme af samordningen af reguleringsmæssige afgørelser og tiltag til beskyttelse af folkesundheden, f.eks. støtte til indbringelsesprocedurer, oprettelse af en database til periodiske sikkerhedsopdateringer (PSUR'er) og overvågning af litteraturen;
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).
Danish: Formålet med indsendelsen af oplysninger er oprettelse af en fuldstændig fortegnelse over alle godkendte humanmedicinske lægemidler i EØS, herunder lægemidler, der er godkendt centralt via EMA, og dem, der er godkendt nationalt via de nationale kompetente myndigheder.
English: Why submit: Scope
Danish: Hvorfor man skal indsende oplysninger: Anvendelsesområde
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;
Danish: • kodning af de oplysninger om stoffer og produkter, der indberettes i individuelle bivirkningsrapporter (ICSR) inden for rammerne af Eudravigilance-systemet til at understøtte arbejdet med vurdering af signaler indenfor lægemiddelovervågning samt dataanalyse og business intelligence i agenturet;
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.
Danish: Denne lovbestemmelse pålægger alle indehavere af markedsføringstilladelser for humanmedicinske lægemidler i Det Europæiske Økonomiske Samarbejdsområde (EØS) at indsende oplysninger til det Europæiske Lægemiddelagentur (EMA) i det elektroniske format, der betegnes artikel 57-formatet eller eXtended EudraVigilance Product Report Message (XEVPRM)-formatet.
English: • medicinal products authorised through the mutual recognition procedure;
Danish: • lægemidler godkendt ved den gensidige anerkendelsesprocedure;
English: • medicinal products authorised through the decentralised procedure.
Danish: • lægemidler godkendt ved den decentrale procedure.
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.
Danish: Efter juli 2012 skal indehavere af markedsføringstilladelser indsende oplysninger om nye markedsføringstilladelser udstedt efter 2. juli 2012 senest 15 kalenderdage efter datoen for de nationale kompetente myndigheders meddelelse om udstedelsen af markedsføringstilladelsen.
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.
Danish: Oplysninger om ændringer i betingelserne for markedsføringstilladelser efter en ændring, overførsel, fornyelse, suspendering, inddragelse eller tilbagetrækning skal meddeles til EMA senest 30 kalenderdage fra den dato, hvor ændringerne er godkendt i henhold til den vejledning og de processer, der beskrives i Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance.
English: For enquiries related to the EU SME definition please contact the SME office (sme@ema.europa.eu).
Danish: Forespørgsler vedrørende EU's definition af SMV'er bedes rettet til SMV-kontoret (sme@ema.europa.eu).
English: To begin data submission of authorised medicinal products, marketing-authorisation holders need to register with Eudravigilance.
Danish: For at påbegynde indsendelsen af oplysninger om godkendte lægemidler skal indehaverne af markedsføringstilladelser registrere sig i Eudravigilance.
English: For enquires on how to register contact the Eudravigilance registration office (eudravigilanceregistration@ema.europa.eu).
Danish: Forespørgsler om, hvordan virksomheden registrerer sig, bedes rettet til registreringskontoret for Eudravigilance (eudravigilanceregistration@ema.europa.eu).
English: • nationally authorised medicinal products;
Danish: • nationalt godkendte lægemidler;
English: • centrally authorised medicinal products;
Danish: • centralt godkendte lægemidler;
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.:
Danish: Indehavere af markedsføringstilladelser skal til EMA indsende oplysninger om alle de lægemidler, de har markedsføringstilladelse for i EØS, dvs.: