Risk management plans

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Waldenstrom Macroglobulinemia, Date of authorisation: 22/11/2021, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Locametz, gozetotide, Radionuclide Imaging, Date of authorisation: 09/12/2022, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms, Date of authorisation: 22/05/2012, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Exforge HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Hypertension, Date of authorisation: 15/10/2009, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors;Radionuclide Imaging, Date of authorisation: 08/12/2016, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Adakveo, crizanlizumab, Anemia, Sickle Cell, Date of authorisation: 28/10/2020, Revision: 6, Status: Withdrawn

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023

Referral: Hydroxyprogesterone-containing medicinal products, hydroxyprogesterone, associated names: Lentogest,Progesterone Retard Pharlon,Proluton Depot, Article 31 referrals, Procedure started, 29/09/2023