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Language Title Keywords Native rendition Pdf rendition
LV Atbildīgās personas vai izplatītāja paziņojums kompetentajai iestādei par Būtisku Nevēlamu Ietekmi (BNI) - A Veidlapa Download native rendition (165.921) Download PDF rendition (167.303)
LT Pranešimas apie rimtą nepageidaujamą poveikį, kurį kompetentingai institucijai perduoda atsakingas asmuo arba platintojas - A Forma Download native rendition (131.46) Download PDF rendition (132.818)
CS Oznamování Závažné Nežádoucí Účinky (ZNÚ) odpovědnou osobou nebo distributorem příslušnému orgánu - Formulář A Download native rendition (212.992) Download PDF rendition (214.384)
SL Resen neželeni učinek, ki ga odgovorna oseba ali distributer sporoča pristojnemu organu - Obrazec A Download native rendition (153.53) Download PDF rendition (154.912)
HR Obavijest odgovorne osobe ili distributera o ozbiljnim neželjenim posljedicama nadležnom tijelu – Obrazac A Download native rendition (126.011) Download PDF rendition (127.411)
SK Oznámenie Závažného Nežiaduceho Účinku (ZNÚ) vyplnené zodpovednou osobou alebo distribútorom a adresované príslušnému orgánu - Tlačivo typu A Download native rendition (133.665) Download PDF rendition (135.036)
RO Notificarea Efectelor Nedorite Grave (ENG) de către persoana responsabilă sau distribuitor la autoritatea competentă - Formularul A Download native rendition (126.761) Download PDF rendition (128.132)
DA Indberetning af Alvorlige Uønskede Virkninger (AUV), der foretages af den ansvarlige person eller distributøren, til den kompetente myndighed - Skema A Download native rendition (24.164) Download PDF rendition (25.502)
NS Notification of Severe Undesirable Effects (SUE) by Responsible Person or Distributor to Competent Authority – Form A Download native rendition (126) Download PDF rendition (27.614)
IT Notifica delgli Effetti Indesiderabili Gravi (EIG) all'autorità competente ad opera della persona responsabile o del distributore - Modello A Download native rendition (23.095) Download PDF rendition (24.434)
MT Notifika ta' SUE (effetti serji mhux mixtieqa) lill-awtorità kompetenti minn persuna jew distributur responsabbli - Formola A Download native rendition (163.481) Download PDF rendition (164.863)
HU A felelős személy vagy forgalmazó jelentése az illetékes hatóságnak a súlyos nemkívánatos hatásról - A. Formanyomtatvány Download native rendition (129.125) Download PDF rendition (130.495)
PT Notificação de Efeitos Indesejáveis Graves (EIG) pela pessoa responsável ou distribuidor à autoridade competente - Formulário A Download native rendition (24.688) Download PDF rendition (26.026)
PL Powiadomienie o ciężkim działaniu niepożądanym (SUE) do właściwego organu przez osobę odpowiedzialną lub dystrybutora - Formularz A Download native rendition (139.734) Download PDF rendition (141.094)
SV Anmälan om allvarliga oönskade effekter från ansvarig person eller distributör till behörig myndighet - Blankett A Download native rendition (23.651) Download PDF rendition (24.989)
FR Notification d'un Effet Indésirable Grave (EIG) à l'autorité compétente par la personne responsable ou le distributeur - Formulaire A Download native rendition (24.419) Download PDF rendition (25.745)
BG Съобщаване за Сериозните Нежелани Ефекти (СНЕ) от отговорното лице или от дистрибутора на компетентния орган - Формуляр А Download native rendition (151.642) Download PDF rendition (152.978)
EN Notification of Severe Undesirable Effects (SUE) by Responsible Person or Distributor to Competent Authority – Form A Download native rendition (84.632) N/A
ET TSMist (Tõsisest Soovimatust Mõjust) teatamine pädevale asutusele vastutava isiku või levitaja poolt - Vorm A Download native rendition (23.692) Download PDF rendition (25.019)
ES Notificación de efectos graves no deseados por parte de la persona responsable o del distribuidor a la autoridad competente - Formulario A Download native rendition (25.687) Download PDF rendition (27.013)
NL Kennisgeving van een Ernstige Ongewenste Bijwerking (EOB) door de verantwoordelijke persoon of de distributeur aan de bevoegde instantie - Formulier A Download native rendition (24.127) Download PDF rendition (25.465)
DE Meldung von Ernsten Unerwünschten Wirkungen (EUW) durch die verantwortliche Person oder den Händler an die zuständige Behörde - Formular A Download native rendition (23.707) Download PDF rendition (25.087)
EL Κοινοποιηση Σοβαρών Ανεπιθύμητων Ενεργειών (ΣΑΕ) στισ αρμο∆ιεσ αρχεσ απο υπευθυνα προσΩπα ή ∆ιανομεισ – Εντυπο A Download native rendition (157.384) Download PDF rendition (158.766)
FI Vastuuhenkilön tai jakelijan vakavasta ei-toivotusta vaikutuksesta toimivaltaiselle viranomaiselle toimittama ilmoitus - Lomake A Download native rendition (23.896) Download PDF rendition (25.21)