Pemazyre 4.5 mg, 9mg and 13.5mg - tablets
*Company:
Incyte Biosciences UK LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 08 July 2025
File name
pemazyre-ie-spc-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 March 2024
File name
pemazyre-ie-spc-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 August 2023
File name
pemazyre-ie-pl-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
reporting cutaneous calcification as uncommon adverse drug reaction in the section 4.
Updated on 07 August 2023
File name
pemazyre-ie-spc-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
reporting cutaneous calcification as uncommon adverse drug reaction in the section 4.8.
Updated on 06 March 2023
File name
Pemazyre-ie-spc-PSUR3-mar2023-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Change to section 4.4 non-uraemic calciphylaxis ;Change to section 10 - Date of revision of the text
Updated on 05 December 2022
File name
Pemazyre-ie-spc-4yr-SLE-02dec22-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 June 2022
File name
Pemazyre-ie-spc-FIGHT-19May22-clean.pdf
Reasons for updating
- 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
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 February 2022
File name
Pemazyre SmPC.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
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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
Change to section 4.2 - Posology and method of administration Change to section 4.4 - Special warnings and precautions for use Change to section 4.6 - Pregnancy and lactation Change to section 4.8 - Undesirable effects Change to section 5.1 - Pharmacodynamic properties Change to section 5.2 - Pharmacokinetic properties Change to section 6.3 - Shelf life
Updated on 23 February 2022
File name
Pemazyre SmPC.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Annual renewal- gramatical corrections to the sections: 4.2, 3.3, 4.6, 4.8, 5.1, 5.2
Shelf life change- from 30months to 3years
Updated on 23 February 2022
File name
Package leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
new text in section 2:
Pemazyre with food and drink
Avoid eating grapefruit or drinking grapefruit juice while using this medication.
Updated on 12 April 2021
File name
Package leaflet.pdf
Reasons for updating
- New PIL for new product
Updated on 12 April 2021
File name
Pemazyre SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New
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