Web28 giu 2024 · Dupixent® (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis. Dupixent …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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WebHormone Replacement Therapy - Core SmPC (October 2024) [ Track version] PRAC recommendation on safety signal related to HRT products adopted at the PRAC meeting of 11 - 14 May 2024 (please see EMA's website) EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines. Web1. NAME OF THE MEDICINAL PRODUCT Adtralza 150 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe … WebThe SmPC is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. The Package Leaflet (PL) shall be drawn up in accordance with the SmPC. The Guideline on excipients in the label and package leaflet of medicinal products for human use is also applicable to the SmPC. pineapple slaw for shrimp tacos