Efmody

RSS

hydrocortisone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

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.

This EPAR was last updated on 24/06/2022

Authorisation details

Product details
Name
Efmody
Agency 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 therapeutic chemical (ATC) code
H02AB09
Publication details
Marketing-authorisation holder
Diurnal Europe B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
27/05/2021

Product information

21/06/2022 Efmody - EMEA/H/C/005105 - IB/0004/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Corticosteroids for systemic use

Therapeutic indication

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

Assessment history

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