Pemazyre 4.5 mg, 9mg and 13.5mg - tablets *
Pharmacy Only: Prescription

  • Company:

    Incyte Biosciences UK Ltd
  • Status:

    Updated
  • Legal 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