Benvenuti sul sito web di Farmacovigilanza

Feed rss AIFA: Notizia

18/04/2025

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

Ultime notizie

10/04/2025

Neuropatia periferica indotta da chemioterapia: quando il dolore diventa cronico

Biblioteca Virtuale per la Salute – Piemonte

10/04/2025

Ambiente Informa n.604 del 10 aprile 2025

Agendas and minutes

16/04/2025

Minutes of the CVMP meeting 11-13 March 2025

Public consultations

15/04/2025

Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba

Regulatory and procedural guidelines (human and veterinary)

16/04/2025

Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

Scientific guidelines (human and veterinary)

09/04/2025

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Paediatric investigation plans

14/04/2025

Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously Orbactiv), oritavancin (diphosphate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0074/2024

Orphan designations

09/04/2025

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27/07/2020 Positive

New medicines and opinions: human

14/04/2025

Human medicines European public assessment report (EPAR): Skojoy, aflibercept, Status: Application withdrawn

New medicines and opinions: veterinary

11/04/2025

Veterinary medicines European public assessment report (EPAR): Nobilis Multriva Gm+REOm, avian infectious bursal disease,avian reovirus vaccine (inactivated), Status: Opinion