Lipitor 10 mg film-coated tablets
*Company:
Upjohn EESVStatus:
UpdatedLegal 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 09 December 2024
File name
Lipitor FCT Patient Information Leaflet - 002808106 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 09 December 2024
File name
10 mg FCT. Summary of Product Characteristics - clean 003047517.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
- 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)
Updated on 08 October 2024
File name
10 mg. Summary of Product Characteristics. clean- 003047517.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 July 2024
File name
Lipitor Patient Information Leaflet - 002808106 clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 December 2023
File name
Patient Information Leaflet - IE - Lipitor FCT - addition of Medis site.pdf
Reasons for updating
- Addition of 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~2.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 05 January 2023
File name
Patient Information Leaflet - 002808106.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 February 2022
File name
Reg SPC LR 33_5 10mg 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 10mg 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 10mg 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 20 September 2021
File name
DEC202112235-V_Reg SPC LR 31_1 10mg 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 20 September 2021
File name
DEC202112235-V_Reg PIL LR 35_1 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 10mg 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 10mg 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 10mg 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 10mg 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 10mg 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
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The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
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Updated on 28 November 2018
File name
Reg SPC LR 25_1 10mg 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_10mg_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_10mg_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 17 February 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 February 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 16 February 2017
File name
PIL_8757_784.pdf
Reasons for updating
- New PIL for new product
Updated on 16 February 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
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 22 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to appearance of the medicine
- Change to name of manufacturer
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
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 30 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
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 20 May 2014
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 07 November 2013
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
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
Updated on 05 July 2012
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
Updated on 02 July 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 11 January 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Updated on 09 January 2012
Reasons for updating
- Change to MA holder contact details
Updated on 03 January 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2011
Reasons for updating
- Introduction of new pack/pack size
Updated on 02 September 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 31 August 2011
Reasons for updating
- Introduction of new pack/pack size
Updated on 10 May 2011
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 May 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 March 2011
Reasons for updating
- Change due to harmonisation of PIL
Updated on 10 March 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- 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 5.4 - Radiation dosimetry
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
- 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 SmPC has been updated to harmonise the text according to the article 30 referral. This has resulted in a rewrite of the full SPC. As part of the module 3 harmonisation we have switched from the heritage oval tablets to the small round tablets
Updated on 19 October 2010
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10 have changed
Updated on 15 October 2010
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 04 June 2010
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
Updated on 01 June 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 13 May 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 19 April 2010
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
-
- Section 6.1 list of excipients has been updated to reflect the change
Updated on 08 April 2010
Reasons for updating
- Change of inactive ingredient
Updated on 04 January 2010
Reasons for updating
- Change of manufacturer
Updated on 10 September 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 23 January 2009
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 January 2009
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 December 2008
Reasons for updating
- Change to drug interactions
Updated on 19 December 2008
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4. Special warnings and special precautions for use
Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy (see Section 4.5)
4.5. Interactions with other medicinal products and other forms of interaction
Erythromycin, clarithromycin: Erythromycin and clarithromycin are known.At atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the clarithromycin treatment course is completed and CPK has returned to baseline values.
Itraconazole: Concomitant administration At atorvastatin doses exceeding 40 mg, clinical monitoring including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the itraconazole treatment course is completed and CPK has returned to baseline values.
Fusidic Acid: Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in post-marketing experience with this combination. Patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate.
Updated on 21 August 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section1: The name of the product has been updated to include the pharmaceutical form.
Updated on 21 August 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
Updated on 18 December 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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
Section 4.4 and 5.1 – additional of SPARCL data and information
Section 4.4 and 4.5 – inclusion of information about drug-drug interactions with atorvastatin
Section 4.8 – Update Adverse Drug Reaction information after the completion of the MRP renewal
Updated on 18 December 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 24 January 2007
Reasons for updating
- Change to, or new use for medicine
Updated on 16 January 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
4.1 - update to existing primary prevention indication
4.2 - addition of dosing information relating to primary prevention studies
5.1 - addition of CARDS primary prevention study description
- modification of existing
- addition of MIRACL acute coronary syndrome study description
Updated on 31 October 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.2 of the SmPC for Lipitor Tablets (all strengths) to include the paediatric dosing information below:
Updated on 01 September 2006
Reasons for updating
- Improved electronic presentation
Updated on 14 August 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 September 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 September 2005
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 July 2005
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 July 2005
Reasons for updating
- Change to how the medicine works
Updated on 16 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 24 March 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may be renewed (B)