For help on how to get the results you want, see our search tips.
1339 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Shortages Remove Shortages filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Document regulatory outcome
Suspension Remove Suspension filter
Maintenance Remove Maintenance filter
-
List item
Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
List item
Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk
Active substance: ulipristal acetate, DHPC type: Interim measures, Last updated: 23/03/2020 -
List item
Direct healthcare professional communication (DHPC): INOmax (nitric oxide): Difficulties in closing the cylinder valves after use: precautions for use when disconnecting the cylinders from pressure regulators
Active substance: Nitric oxide, DHPC type: Quality defect, Last updated: 03/06/2021 -
List item
Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021 -
List item
Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021 -
List item
Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
List item
Direct healthcare professional communication (DHPC): Lymphoseek® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 07/12/2021 -
List item
Direct healthcare professional communication (DHPC): Lymphoseek® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 30/05/2022 -
List item
Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT) (new)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
List item
Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
List item
Direct healthcare professional communication (DHPC): Nulojix (belatacept): Further extension of the temporary restriction in supply up until 3Q 2022
Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 17/01/2022 -
List item
Direct healthcare professional communication (DHPC): Dexmedetomidine: Increased risk of mortality in intensive care unit (ICU) patients ≤65 years (new)
Active substance: dexmedetomidine hydrochloride, DHPC type: Safety signal, Last updated: 16/06/2022 -
List item
Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm (new)
Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 30/06/2022