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 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