80 results
-
List item
Direct healthcare professional communication (DHPC): SIMULECT (basiliximab): Do not use WFI ampoules co-packed with vials of sterile freeze-dried powder of Simulect 10mg and 20mg
Active substance: basiliximab, DHPC type: Quality defect, Last updated: 21/04/2023 -
List item
Direct healthcare professional communication (DHPC): CYSTAGON (mercaptamine bitartrate)
Active substance: mercaptamine bitartrate, DHPC type: Quality defect, Last updated: 15/02/2023 -
List item
Referral: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020 -
List item
Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use
estradiol, associated names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff, Montadiol, Article 31 referrals
Status: CMDh final position, opinion/position date: 30/01/2020, Last updated: 08/04/2020 -
List item
Referral: Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep
tylosin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 20/06/2019, EC decision date: 20/09/2019, Last updated: 19/11/2019 -
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): GLOBAL RECALL: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion
Active substance: Ceftolozane, tazobactam, DHPC type: Quality defect, Last updated: 22/12/2020 -
List item
Direct healthcare professional communication (DHPC): Arti-Cell® Forte and RenuTend® market recall of select product batches
Active substance: Equine allogeneic mesenchymal stem cells, DHPC type: Quality defect, Last updated: 04/05/2023 -
List item
Direct healthcare professional communication (DHPC): Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes
Active substance: lopinavir, ritonavir, DHPC type: Quality defect, Last updated: 04/01/2021 -
List item
Direct healthcare professional communication (DHPC): Champix (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the Pfizer acceptable daily intake limit
Active substance: varenicline, DHPC type: Quality defect, Last updated: 15/07/2021 -
List item
Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Batch-specific product recall
Active substance: alpha1-proteinase inhibitor (human), DHPC type: Quality defect, Last updated: 12/02/2021 -
List item
Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021 -
List item
Certification of medicinal products
Last updated: 03/11/2023 -
List item
Quality: non-immunologicals
Last updated: 18/10/2023 -
List item
Quality: specific types of products
Last updated: 18/10/2023 -
List item
Quality Innovation Group
Last updated: 12/10/2023 -
List item
ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
Last updated: 19/07/2023 -
List item
Listen-and-learn focus group meeting of the Quality Innovation Group
Online, 13/03/2023, Last updated: 17/05/2023 -
List item
Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
Online, 13:00 - 17:00 Amsterdam time (CET), 15/12/2022, Last updated: 10/02/2023 -
List item
Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
Last updated: 19/12/2022 -
List item
Seventh Nitrosamine Implementation Oversight Group (NIOG) meeting
Online, 14/07/2022, Last updated: 03/08/2022 -
List item
Quality of medicines questions and answers: Part 2
Last updated: 21/07/2022 -
List item
Third Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
Online, 04/05/2022, Last updated: 25/05/2022 -
List item
Second Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
Online, 08/12/2021, Last updated: 17/12/2021 -
List item
16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
Online, 09:00 - 13:15 Amsterdam time (CET), 17/11/2021, Last updated: 06/12/2021