Sprycel 10 mg/mL powder for oral suspension

  • Name:

    Sprycel 10 mg/mL powder for oral suspension

  • Company:
    info
  • Active Ingredients:

    dasatinib monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/07/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 4/7/2019

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Bristol-Myers Squibb Pharma EEIG

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1 - 0 of 19 items.Total: Infinity pages

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 4 July 2019 PIL

Reasons for updating

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

Updated on 4 July 2019 SmPC

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 7 May 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 May 2019 SmPC

Reasons for updating

  • New SmPC for new product

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