Efmody - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

hydrocortisone

Opinion

On 29 January 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Efmody. The marketing authorisation holder for this medicinal product is Neurocrine Netherlands B.V.

The CHMP adopted changes to the existing indication as follows:

Efmody is indicated in adolescents aged 12 years and over and adults for the:

• Treatment of adrenal insufficiency (AI)
• Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Efmody (EMA/VR/0000282500)

Adopted Reference Number: EMADOC-1700519818-2850511

Key facts

• Name of medicine:
  Efmody
• EMA product number:
  EMEA/H/C/005105
• Active substance:
  hydrocortisone
• International non-proprietary name (INN) or common name:
  hydrocortisone
• Therapeutic area (MeSH):
  Adrenal Hyperplasia, Congenital
• Anatomical therapeutical chemical (ATC) code:
  H02AB09
• Marketing authorisation holder:
  Immedica Pharma AB
• Date of opinion:
  29/01/2026
• Státusz:
  Positive