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EMA Product

Efmody

Product approved by European Medicines Agency (EU)

Basic Information

Efmody

Regulatory Information

EMEA/H/C/005105

Authorised

May 27, 2021

March 25, 2021

6

November 15, 2024

Company Information

Neurocrine Netherlands B.V.,Van Heuven Goedhartlaan 935 A,1181 LD Amstelveen,NETHERLANDS

Netherlands

Van Heuven Goedhartlaan 935 A 1181 LD Amstelveen

neurocrine netherlands b.v.

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.

Overview Summary

Efmody is a medicine used to treat an inherited condition called congenital adrenal hyperplasia (CAH) in patients 12 years old and above. CAH is rare, and Efmody was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 27 July 2005. Further information on the orphan designation can be found [here](/en/medicines/human/orphan-designations/eu-3-05-296). Efmody contains the active substance hydrocortisone and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Efmody has a different use and is available in different strengths as capsules formulated to release the active substance over a prolonged period. The reference medicine for Efmody capsules is Hydrocortone tablets.

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