Apremilast
Selective Immunosuppressants
Sold as OTEZLA
- Drug class
- Selective Immunosuppressants
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 52
Overview
Apremilast is an active pharmaceutical ingredient in the Selective Immunosuppressants group (L04AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 31 | May 29, 2026 |
| CA Canada | Health Canada | 19 | May 13, 2026 |
| EU European Union | EMA | 2 | March 20, 2026 |
GBUnited Kingdom· MHRA
31 products
Uses
1). Psoriasis Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Behçet’s disease Apremilast is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
How to take
CACanada· Health Canada
19 products
Uses
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS.................................................................................................. 4 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS .................................................................................................. 7 DRUG INTERACTIONS ................................................................................................
11 DOSAGE AND ADMINISTRATION ............................................................................. 14 OVERDOSAGE.............................................................................................................. 15 ACTION AND CLINICAL PHARMACOLOGY .............................................................
15 STORAGE AND STABILITY ........................................................................................ 18 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................... 18 PART II: SCIENTIFIC INFORMATION ........................................................................
EUEuropean Union· EMA
2 products
Uses
1). Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Paediatric psoriasis Apremilast Accord is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy. Behçet’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
How to take
Drug interactions
Known interactions involving Apremilast. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB200751504 · revised May 1, 2026
- [2]Health Canada (DPD) · 02518910 · revised December 31, 2025
- [3]European Medicines Agency · EMEA/H/C/006208 · revised March 20, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.