Lipitor 20mg film-coated tablets
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 December 2023
File name
Patient Information Leaflet - IE - Lipitor FCT - addition of Medis site.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 11 July 2023
File name
Patient Information Leaflet - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 26 April 2023
File name
Patient Information Leaflet - 003067906.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 April 2023
File name
SMPC-I~4.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 January 2023
File name
Patient Information Leaflet - 002808106.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 February 2022
File name
Reg SPC LR 33_5 20mg IE-Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 6.1 List of excipients
Updated on 07 February 2022
File name
Reg PIL LR 37_4 IE-Clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 28 January 2022
File name
DEC202200482-V_Reg SPC LR 33_4 20mg IE - Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 6.1 List of excipients: Excipients update
Updated on 28 January 2022
File name
DEC202200482-V_Reg PIL LR 37_3 IE - Clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 January 2022
File name
DEC202115395-V_Reg SPC LR 33_1 20mg IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 13 January 2022
File name
DEC202115395-V_Reg PIL LR 36_1 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 21 September 2021
File name
DEC202112235-V_Reg SPC LR 31_1 20mg IE - clean.pdf
Reasons for updating
- 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
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 September 2021
File name
DEC202112235-V_Reg PIL LR 35_1 IE - clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 September 2021
File name
DEC202112235-V_Reg SPC LR 31_1 20mg IE - clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 31 March 2021
File name
DEC202104589-V_Reg SPC LR 30_1 20mg IE-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 March 2021
File name
DEC202104589-V_Reg PIL LR 34_0 IE-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
Updated on 06 October 2020
File name
Reg PIL LR 32_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 19 November 2019
File name
DEC201964482_Reg PIL LR 31_1 IE - Clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 November 2019
File name
DEC201964482_Reg SPC LR 29_1 20mg IE - Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 July 2019
File name
DEC201939369_Reg PIL LR 30_2 IE .pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 July 2019
File name
DEC201939369_Reg SPC LR 28_2 20mg IE .pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC: Updated as follows:
Section 4.8- updated to include “Muscle rapture” under rare side effects on PRAC recommendation (All strengths).
Updated on 13 May 2019
File name
DEC201924154_Reg PIL LR 29_1 IE - Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 May 2019
File name
DEC201924154_Reg SPC LR 27_1 20mg IE - Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Sections 4.8, 10 has been updated as per the CMDh endorsed PRAC recommendation to include lupus related events.
Updated on 11 January 2019
File name
Reg PIL LR 28_1 IE - Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 11 January 2019
File name
Reg SPC LR 26_1 20mg IE- Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
|
Updated on 28 November 2018
File name
Reg SPC LR 25_1 20mg IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 30 August 2018
File name
Reg_SPC_LR_25_1_20mg_IE_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.
Section 5.1: an editorial update to the footnote for Table 3
Updated on 05 June 2018
File name
Reg_SPC_LR_25_1_20mg_IE_clean.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.
Section 5.1: an editorial update to the footnote for Table 3
Updated on 03 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 March 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update
Section 4.2, 4.8, 5.1 - paediatric data update
Section 4.4 – paediatric data update, CMDh wording for fusidic acid interaction
Updated on 03 March 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update
Section 4.2, 4.8, 5.1 - paediatric data update
Section 4.4 – paediatric data update, CMDh wording for fusidic acid interaction
Updated on 16 February 2017
File name
PIL_8757_784.pdf
Reasons for updating
- New PIL for new product
Updated on 04 January 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
updates to sections:
2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD templateUpdated on 04 January 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
updates to sections:
2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD templateUpdated on 08 April 2015
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 4.4: Special warnings and precautions for use
Sub-heading: Concomitant treatment with other medicinal products
Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.
Section 4.8. Undesirable effects
Sub-heading: Musculoskeletal and connective tissue disorders
Addition of reference to section 4.4.
Updated on 08 April 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 4.4: Special warnings and precautions for use
Sub-heading: Concomitant treatment with other medicinal products
Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.
Section 4.8. Undesirable effects
Sub-heading: Musculoskeletal and connective tissue disorders
Addition of reference to section 4.4.
Updated on 29 May 2014
Reasons for updating
- 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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 May 2014
Reasons for updating
- 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 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 07 November 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
changes to section 4.4, 4.5, 4.8
Updated on 07 November 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
changes to section 4.4, 4.5, 4.8