Opzelura 15 mg/g cream
*Company:
Incyte Biosciences UK LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 March 2026
File name
Opzelura-ie-spc-clean-Mar26.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Added phosphoric acid to list of excipients following EU approval
Updated on 25 March 2026
File name
Opzelura-ie-pil-clean-Mar26.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of phosphoric acid
Updated on 21 August 2025
File name
Opzelura-ie-pil-clean-aug25.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 21 August 2025
File name
Opzelura-ie-spc-clean-18Aug25.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 December 2023
File name
ie-SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 December 2023
File name
ie-LEAFLET.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 08 December 2023
File name
ie-SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 December 2023
File name
ie-LEAFLET.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 18 July 2023
File name
ie-spc.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 July 2023
File name
ie-spc.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 July 2023
File name
ie-leaflet.pdf
Reasons for updating
- New PIL for new product
Incyte Biosciences UK Ltd
Address:
First Floor Q1, The Square, Randalls Way, Leatherhead, KT22 7TWMedical Information E-mail:
eumedinfo@incyte.comTelephone:
+44 800 7833711Website:
https://www.incyte.comMedical Information Direct Line:
00800 000 274 23