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 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