Calquence 100 mg hard capsules *

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    Updated
  • 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 07 October 2021

File name

20210930 Package Leaflet IE MT Calquence AKA ACE-HV-114 ONC 20 0033_1633598186.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

4.       Possible side effects

[..]

 

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

6.       Contents of the pack and other information

[..]

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

 

 

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

 

This leaflet was last revised in 11/2020September 2021.

Updated on 07 October 2021

File name

20210930 SPC IE MT Calquence Variation AKA ACE-HV-114 ONC 21 0032_1633597892.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

4.5     Interaction with other medicinal products and other forms of interaction

[..]

Co-administration with moderate CYP3A inhibitors (400 mg fluconazole as single dose or 200 mg isavuconazole as repeated dose for 5 days) in healthy subjects increased acalabrutinib Cmax and AUC by 1.4-fold to 2-fold while the active metabolite ACP-5862 Cmax and AUC was decreased by 0.65-fold to 0.88-fold relative to when acalabrutinib was dosed alone. No dose adjustment is required in combination with moderate CYP3A inhibitors. Monitor patients closely for adverse reactions (see Section 4.2).

 

4.8     Undesirable effects

[..]

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom (Northern Ireland)

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

 

10.     DATE OF REVISION OF THE TEXT

 

24th June30th September 2021

Updated on 30 September 2021

File name

20210624 SPC IE MT Calquence Variation Protein Binding ONC 21 0023_1632995889.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New SmPC for new product

Updated on 30 September 2021

File name

20201105 Package Leaflet IE MT Calquence MAA ONC 20 0028_1632995792.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for new product