Crestor 5mg/10mg/20mg/40mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Grunenthal Pharma Ltd.
  • Status:

    Updated
  • Legal Category:

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

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

Updated on 14 October 2024

File name

ie-smpc-crestor-fct-clean version 4.0.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)

Updated on 23 September 2024

File name

ie-pil-crestor-Grouped type IB-addtion of FRT as manufacturer clean version 5.0.pdf

Reasons for updating

  • Addition of manufacturer

Free text change information supplied by the pharmaceutical company

Addition of Farmaceutici Formenti S.p.A., Italy as a batch release site manufacturer.

Updated on 16 January 2024

File name

ie-pil-crestor-type II CCDS update clean version 4.0.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

HPRA National Approval of Type II variation CCDS and QRD updates.

Updated on 16 January 2024

File name

ie-smpc-crestor-fct-clean version 3.0.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

Type II National Approval of Crestor by HPRA following CCDS and QRD updates to sections 4.3, 4.4, 4.5 and 4.6 of the SmPC.

Updated on 23 June 2023

File name

ie-pil-crestor-PRAC change MG clean version 2.0.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Type IA PRAC change - addition of Myasthenia Gravis to the package leaflet in Section 2 and Section 4.

Updated on 23 June 2023

File name

ie-smpc-crestor-fct-clean version 2.0.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Type IA PRAC variation approval - addition of Myasthenia Gravis to SmPC sections 4.4 and 4.8.

Updated on 01 June 2023

File name

ie-pil-crestor-MAT clean 05.04.2023.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

The Marketing Authorisation Transfer (MAT) was approved by HPRA on 26th May 2023.

Updated on 01 June 2023

File name

ie-smpc-crestor-fct-MAT clean -05.04.2023.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

The Marketing Authorisation Transfer (MAT) was granted by HPRA on 26th May 2023 to Grunenthal Pharma Limited.