EFMODY Modified-release hard capsule Ref.[50004] Active ingredients:

Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072

Product name and form

Efmody 5 mg modified-release hard capsules.

Efmody 10 mg modified-release hard capsules.

Efmody 20 mg modified-release hard capsules.

Pharmaceutical Form
Modified-release hard capsules. Efmody 5 mg modified-release hard capsules: A capsule (approx.19 mm long) with an opaque blue cap and opaque white body printed with “CHC 5 mg” containing white to off white granules. Efmody 10 mg modified-release hard capsules: A capsule (approx.19 mm long) with an opaque green cap and opaque white body printed with “CHC 10 mg” containing white to off white granules. Efmody 20 mg modified-release hard capsules: A capsule (approx. 22 mm long) with an opaque orange cap and opaque white body printed with “CHC 20 mg” containing white to off white granules.

Qualitative and quantitative composition

Efmody 5 mg modified-release hard capsules: Each modified-release hard capsule contains 5 mg hydrocortisone.

Efmody 10 mg modified-release hard capsules: Each modified-release hard capsule contains 10 mg hydrocortisone.

Efmody 20 mg modified-release hard capsules: Each modified-release hard capsule contains 20 mg hydrocortisone.

For the full list of excipients, see section 6.1.

List of Excipients
Granules: Microcrystalline cellulose Povidone Methacrylic acid-methyl methacrylate copolymer (1:2) Methacrylic acid-methyl methacrylate copolymer (1:1) Talc Dibutyl sebacate Capsule: Gelatin Efmody 5 mg modified-release hard capsules (white/blue): Titanium dioxide (E171) Indigotine (E132) Efmody 10 mg modified-release hard capsules (white/green): Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Efmody 20 mg modified-release hard capsules (white/orange): Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Printing ink: Shellac Black iron oxide (E172) Propylene glycol Potassium hydroxide

Pack sizes and marketing

The capsules are provided in high-density polyethylene bottles with child resistant, tamper-evident polypropylene screw cap with integrated desiccant.

Pack size: 1 bottle containing 50 modified-release hard capsules.

Marketing authorization holder

Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072

Marketing authorization dates and numbers

Efmody 5 mg modified-release hard capsules EU/1/21/1549/001 (50 capsules)
Efmody 10 mg modified-release hard capsules EU/1/21/1549/002 (50 capsules)
Efmody 20 mg modified-release hard capsules EU/1/21/1549/003 (50 capsules)

Date of first authorisation: 27 May 2021

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