Pemazyre 4.5 mg, 9mg and 13.5mg - tablets * Pharmacy Only: Prescription
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 22 June 2022
File name
62b30a971dfbe.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_1645644011.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_1645633318.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_1645625380.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_1618228666.pdf
Reasons for updating
- New PIL for new product
Updated on 12 April 2021
File name
Pemazyre SmPC_1618221779.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