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Core SmPC/PL

(see also Post referral Phase)

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  • Fludeoxyglucose (18F) - Revised Core SmPC and PL (December 2010)
  • Hormone Replacement Therapy - Core Package Leaflet (March 2017) [Track version]
  • Hormone Replacement Therapy - Core SmPC (March 2017) [Track version]

    PRAC recommendation on safety signal related to HRT products adopted at the PRAC meeting of 30 November - 3 December 2015  (please see EMA's website)
  • Hormone Replacement Therapy - MRFG-PhVWP agreed updated core SmPC (October 2002)
  • Hormone Replacement Therapy - SmPC wording for medicinal products used in HRT with regard to increased risk of venous thromboembolism as agreed by the PhVWP (September 2001)
  • Hormone Replacement Therapy - SmPC wording for medicinal products used in HRT with regard to increased risk of breast cancer as agreed by the PhVWP (July 2001)
  • EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines
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