Sprycel 10 mg/mL powder for oral suspension *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 June 2021

File name

20210610 IE SPRYCEL PFOS - SmPC clean_1624472112.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 update ATC code from L01XE06 to L01EA02

Section 6.3 update of shelf life from 2 years to 3 years for the Unopened bottle

 

Updated on 23 June 2021

File name

20210610 IE SPRYCEL PFOS - PIL clean_1624470919.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

After the manufacturer details the list of Local Representative was removed from section 6 and the date of revision has been updated

Updated on 16 March 2021

File name

2021 02 25 Sprycel PFOS PIL IE-clean_1615930364.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 16 March 2021

File name

2021 02 25 Sprycel PFOS SmPC IE-clean_1615930307.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC Section 4.4 (Special warnings and precautions for use)
Addition of paragraph ‘Effects on growth and development in paediatric patients’ 
[...] Growth retardation has been observed in paediatric patients treated with SPRYCEL in clinical trials (see section 4.8). Monitoring of bone growth and development in paediatric patients is recommended.

Date of Revision of Text: 25 February 2021
 

Updated on 12 March 2021

File name

2021 02 25 Sprycel PFOS PIL UK IE-clean_1615560678.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 March 2021

File name

2021 02 25 Sprycel PFOS SmPC UK IE-clean_1615560600.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC Section 4.4 (Special warnings and precautions for use)
Addition of paragraph ‘Effects on growth and development in paediatric patients’ 
[...] Growth retardation has been observed in paediatric patients treated with SPRYCEL in clinical trials (see section 4.8). Monitoring of bone growth and development in paediatric patients is recommended.

Date of Revision of Text: 25 February 2021
 

Updated on 04 July 2019

File name

2019 06 27 Sprycel PFOS PIL UK-IE PK Fasted Conditions_clean_1562235344.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 04 July 2019

File name

2019 06 27 Sprycel PFOS SmPC UK-IE PK Fasted Conditions_clean_1562235412.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Existing/new pharmacokinetics (PK) analyses together with a review of literature data on the dasatinib PK profile in fasted conditions. The following sections of the SmPC are updated (changes marked in blue):

·         SmPC Section 4.2 - Method of administration […] SPRYCEL can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2). […]

·         SmPC Section 5.2 - Pharmacokinetic properties - Absorption
[…]
Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions.
Based on the patient population PK analysis, variability in dasatinib exposure was estimated to be mainly due to inter-occasion variability in bioavailability (44% CV) and, to a lesser extent, due to inter-individual variability in bioavailability and inter-individual variability in clearance (30% and 32% CV, respectively). The random inter-occasion variability in exposure is not expected to affect the cumulative exposure and efficacy or safety.
[…]

Updated on 07 May 2019

File name

2019 03 28 Sprycel PFOS PIL UK-IE PSUR 15_clean_1556887741.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 May 2019

File name

2019 03 28 Sprycel PFOS SmPC UK-IE PSUR 15_clean_1556887061.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)