For help on how to get the results you want, see our search tips.
1804 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
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Categories
Human Remove Human filter
Document regulatory outcome
Variation Remove Variation filter
Maintenance Remove Maintenance filter
Suspension Remove Suspension filter
-
List item
Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) (updated)
Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021 -
List item
Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine
Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 -
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): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020 -
List item
Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams
Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020 -
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): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020 -
List item
Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
List item
Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
List item
Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
List item
Direct healthcare professional communication (DHPC): Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy
Active substance: leuprorelin, DHPC type: Referral - Article 31, Last updated: 02/10/2020 -
List item
Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020 -
List item
Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
List item
Direct healthcare professional communication (DHPC): Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)
Active substance: Fingolimod, DHPC type: Periodic safety update report, Last updated: 10/11/2020 -
List item
Direct healthcare professional communication (DHPC): Tecfidera (dimethyl fumarate): Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia
Active substance: dimethyl fumarate, DHPC type: Type II variation, Last updated: 12/11/2020 -
List item
Direct healthcare professional communication (DHPC): Important information on Gliolan (5-aminolevulinic acid, 5-ALA): What to do in case of delayed surgery and information on fluorescence in non high-grade glioma
Active substance: 5-aminolevulinic acid hydrochloride, DHPC type: Type II variation, Last updated: 01/12/2020 -
List item
Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury
Active substance: metamizole, DHPC type: Periodic safety update report, Last updated: 15/12/2020 -
List item
Direct healthcare professional communication (DHPC): Risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations to Alkindi (hydrocortisone granules in capsules for opening)
Active substance: hydrocortisone, DHPC type: Safety signal, Last updated: 04/02/2021 -
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): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy (new)
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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 (new)
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): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders (new)
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021