Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Immedica Pharma AB, 113 63 Stockholm, Sweden
Efmody 5 mg modified-release hard capsules.
Efmody 10 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 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.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. |
| List of Excipients |
|---|
|
Granules: Microcrystalline cellulose (E461) Capsule: Gelatin Efmody 5 mg modified-release hard capsules (white/blue) Titanium dioxide (E171) Efmody 10 mg modified-release hard capsules (white/green) Titanium dioxide (E171) Printing ink: Shellac |
The capsules are provided in high-density polyethylene bottles with child resistant, tamper-evident polypropylene screw cap with integrated desiccant. Each bottle contains 50 modified-release hard capsules.
Pack size:
Carton containing 1 bottle of 50 modified-release hard capsules.
Carton containing 2 bottles of 50 modified-release hard capsules (100 capsules).
Not all pack sizes may be marketed.
Immedica Pharma AB, 113 63 Stockholm, Sweden
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 5 mg modified-release hard capsules EU/1/21/1549/004 (100 (2x50) capsules)
Efmody 10 mg modified-release hard capsules EU/1/21/1549/005 (100 (2x50) capsules)
Date of first authorisation: 27 May 2021
Date of latest renewal: 09 January 2026
| Drug | Countries | |
|---|---|---|
| EFMODY | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania |
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