|
- Homepage | European Medicines Agency
Update of section 4 4 of the SmPC in order to strengthen the existing warning on ‘Aseptic Meningitis Syndrome (AMS)’ by the addition of monitoring precautions for recurrent AMS, associated with IVIg treatment, potentially progressing to brain oedema (cerebral oedema), based on post-marketing data
- Section 4. 4: Special warnings and precautions for use - studylib. net
Risk Management Plan Summary Warning in section 4 4 of the SmPC (LVEF should be evaluated in all patients prior to initiation of treatment with active substance X to ensure that the patient has a baseline LVEF that is within the institutions normal limits
- Section 4. 4: Special warnings and precautions for use
Warning in section 4 4 of the SmPC (LVEF should be evaluated in all patients prior to initiation of treatment with active substance X to ensure that the patient has a baseline LVEF that is within the institutions normal limits
- Scientific guidelines with SmPC recommendations
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells
- CMDh Position on Periodic Safety Update Reports for the active . . .
Update of section 4 4 of the SmPC to amend a warning precaution regarding lithium toxicity following bariatric surgery The Package leaflet is updated accordingly
- Public consultation on the proposed Strategy to Better Protect Public . . .
1 Proposal to add a new section to the SmPC to highlight key safety information and how to minimize risks Instead of adding a new section, the Commission should take steps to ensure a more effective use of the existing section 4 4, Special warnings and precautions for use Background:
- Section 4. 4 Special warning and precautions for use - PDF4PRO
Risk Management Plan Summary warning in Section of the SmPC (LVEF should be evaluated in all patients prior to initiation of treatment with active substance X to ensure that the patient has a baseline LVEF that is within the institutions normal limits )
- List of centrally authorised products requiring a notification of a . . .
Update of section 4 4 of the SmPC to add a warning on gastrointestinal perforation in patients who are at higher risk of development of such condition The package leaflet is updated accordingly Parallel distributors must use the annexes dated 03 04 2020 (PSUSA 10581 201907) which are available on the European Commission website
|
|
|