Core SmPC/PL

(see also Post referral Phase)

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• Core SmPCs and PL for radiopharmaceuticals and diagnostic agents

• Hormone Replacement Therapy - Core SmPC (May 2023) [Track version]
• Hormone Replacement Therapy - Core Package Leaflet (July 2023) [Track version]
  
  PRAC recommendation on safety signal related to HRT products adopted at the PRAC meeting of 11 - 14 May 2020  (please see EMA's website)

• EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines