Cerdelga 84 mg capsules, hard *
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 04 December 2020

File name

1.3.1 PIL (10)_1607082512.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 09 November 2020

File name

1.3.1 PIL (7)_1604927388.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 July 2020

File name

IE_1582036678.pdf

Reasons for updating

  • XPIL Removed

EDM Updated on 27 March 2020

File name

Cerdelga Risk Minimisation Patient Card Ireland_IRE_ GZUK.CERD.17.03.0132c(1)_1585302228.pdf

Reasons for updating

  • Replace File

Updated on 18 February 2020

File name

IE_1582036678.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 February 2020

File name

1.3.2 Mock-up PIL UK_1582026535.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 24 December 2019

File name

Cerdelga SPC_1577185039.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 24 December 2019

File name

Cerdelga PIL_1577184913.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions

EDM Updated on 11 October 2019

File name

Patient Alert care_1570791931.pdf

Reasons for updating

  • Add New Doc

Updated on 16 September 2019

File name

PIL (IE)_1568649485.pdf

Reasons for updating

  • New PIL for medicines.ie

EDM Updated on 22 August 2019

File name

IE Prescriber Guide_1566211471.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

To avoid any misinterpretation and to ensure the terms contained within the prescriber guide are aligned with HSE Code of Practice requirements, Sanofi Genzyme have amended the prescriber guide to remove reference to “QD” throughout and replace this with the wording “Once daily”.

Updated on 02 May 2019

File name

SPC Cerdelga 84mg capsules SA1434_1556797878.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

5.2     Pharmacokinetic properties

Absorption

Median time to reach maximum plasma concentrations occurs between 1.5 to 36 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism. Eliglustat is a substrate of the efflux transporter P-gp. Food does not have a clinically relevant effect on eliglustat pharmacokinetics. Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.  Oral dosing of 84 mg eliglustat once daily has not been studied in CYP2D6 poor metabolisers (PMs).

Characteristics in specific groups

CYP2D 6 phenotype

Updated on 07 January 2019

File name

PIL Cerdelga 84mg capsules, hard_1546866636.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 07 January 2019

File name

SPC Cerdelga 84mg capsules, hard_1546866897.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

4.9     Overdose

 

The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients. At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.

 

In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.

 

7.       MARKETING AUTHORISATION HOLDER

 

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

 

Updated on 21 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 December 2017

File name

PIL_17158_657.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 December 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 16 May 2017

Reasons for updating

  • New PIL for medicines.ie
  • Retired from medicines.ie