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Available translations
| Language | Title | Keywords | Native rendition | Pdf rendition |
|---|---|---|---|---|
| DE | Meldung von Ernsten Unerwünschten Wirkungen (EUW) durch die verantwortliche Person oder den Händler an die zuständige Behörde - Formular A | Download native rendition (23.70703125) | Download PDF rendition (25.0869140625) | |
| FI | Vastuuhenkilön tai jakelijan vakavasta ei-toivotusta vaikutuksesta toimivaltaiselle viranomaiselle toimittama ilmoitus - Lomake A | Download native rendition (23.8955078125) | Download PDF rendition (25.2099609375) | |
| SV | Anmälan om allvarliga oönskade effekter från ansvarig person eller distributör till behörig myndighet - Blankett A | Download native rendition (23.6513671875) | Download PDF rendition (24.9892578125) | |
| PT | Notificação de Efeitos Indesejáveis Graves (EIG) pela pessoa responsável ou distribuidor à autoridade competente - Formulário A | Download native rendition (24.6884765625) | Download PDF rendition (26.0263671875) | |
| BG | Съобщаване за Сериозните Нежелани Ефекти (СНЕ) от отговорното лице или от дистрибутора на компетентния орган - Формуляр А | Download native rendition (151.6416015625) | Download PDF rendition (152.9775390625) | |
| NS | Notification of Severe Undesirable Effects (SUE) by Responsible Person or Distributor to Competent Authority – Form A | Download native rendition (126.0) | Download PDF rendition (27.6142578125) | |
| EL | Κοινοποιηση Σοβαρών Ανεπιθύμητων Ενεργειών (ΣΑΕ) στισ αρμο∆ιεσ αρχεσ απο υπευθυνα προσΩπα ή ∆ιανομεισ – Εντυπο A | Download native rendition (157.3837890625) | Download PDF rendition (158.765625) | |
| MT | Notifika ta' SUE (effetti serji mhux mixtieqa) lill-awtorità kompetenti minn persuna jew distributur responsabbli - Formola A | Download native rendition (163.4814453125) | Download PDF rendition (164.86328125) | |
| LT | Pranešimas apie rimtą nepageidaujamą poveikį, kurį kompetentingai institucijai perduoda atsakingas asmuo arba platintojas - A Forma | Download native rendition (131.4599609375) | Download PDF rendition (132.818359375) | |
| EN | Notification of Severe Undesirable Effects (SUE) by Responsible Person or Distributor to Competent Authority – Form A | Download native rendition (84.6318359375) | N/A | |
| HR | Obavijest odgovorne osobe ili distributera o ozbiljnim neželjenim posljedicama nadležnom tijelu – Obrazac A | Download native rendition (126.0107421875) | Download PDF rendition (127.4111328125) | |
| LV | Atbildīgās personas vai izplatītāja paziņojums kompetentajai iestādei par Būtisku Nevēlamu Ietekmi (BNI) - A Veidlapa | Download native rendition (165.9208984375) | Download PDF rendition (167.302734375) | |
| IT | Notifica delgli Effetti Indesiderabili Gravi (EIG) all'autorità competente ad opera della persona responsabile o del distributore - Modello A | Download native rendition (23.0947265625) | Download PDF rendition (24.43359375) | |
| FR | Notification d'un Effet Indésirable Grave (EIG) à l'autorité compétente par la personne responsable ou le distributeur - Formulaire A | Download native rendition (24.4189453125) | Download PDF rendition (25.7451171875) | |
| HU | A felelős személy vagy forgalmazó jelentése az illetékes hatóságnak a súlyos nemkívánatos hatásról - A. Formanyomtatvány | Download native rendition (129.125) | Download PDF rendition (130.4951171875) | |
| 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 (25.6865234375) | Download PDF rendition (27.0126953125) | |
| ET | TSMist (Tõsisest Soovimatust Mõjust) teatamine pädevale asutusele vastutava isiku või levitaja poolt - Vorm A | Download native rendition (23.6923828125) | Download PDF rendition (25.0185546875) | |
| CS | Oznamování Závažné Nežádoucí Účinky (ZNÚ) odpovědnou osobou nebo distributorem příslušnému orgánu - Formulář A | Download native rendition (212.9921875) | Download PDF rendition (214.3837890625) | |
| SK | Oznámenie Závažného Nežiaduceho Účinku (ZNÚ) vyplnené zodpovednou osobou alebo distribútorom a adresované príslušnému orgánu - Tlačivo typu A | Download native rendition (133.6650390625) | Download PDF rendition (135.0361328125) | |
| SL | Resen neželeni učinek, ki ga odgovorna oseba ali distributer sporoča pristojnemu organu - Obrazec A | Download native rendition (153.5302734375) | Download PDF rendition (154.912109375) | |
| PL | Powiadomienie o ciężkim działaniu niepożądanym (SUE) do właściwego organu przez osobę odpowiedzialną lub dystrybutora - Formularz A | Download native rendition (139.734375) | Download PDF rendition (141.09375) | |
| DA | Indberetning af Alvorlige Uønskede Virkninger (AUV), der foretages af den ansvarlige person eller distributøren, til den kompetente myndighed - Skema A | Download native rendition (24.1640625) | Download PDF rendition (25.501953125) | |
| RO | Notificarea Efectelor Nedorite Grave (ENG) de către persoana responsabilă sau distribuitor la autoritatea competentă - Formularul A | Download native rendition (126.7607421875) | Download PDF rendition (128.1318359375) | |
| NL | Kennisgeving van een Ernstige Ongewenste Bijwerking (EOB) door de verantwoordelijke persoon of de distributeur aan de bevoegde instantie - Formulier A | Download native rendition (24.126953125) | Download PDF rendition (25.46484375) |
