Crestor 5mg/10mg/20mg/40mg film-coated tablets
*Company:
Grunenthal Pharma Ltd.Status:
No Recent UpdateLegal 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 13 November 2024
File name
ie-pil-crestor-type IA deletion AZ sites manufacturer clean version 6.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
deletion of AZ sites as manufacturer except for AZ Sweden
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.