Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
SmPC section(s) updated – 2, 10.
PIL section(s) updated – 6.
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
PIL section(s) updated – 6.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
SmPC section(s) updated – 2, 10.
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
PIL section(s) updated – 6.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintDiscontinued Other versions of this medicine may still be available. Information for reference purposes.
Product Documentation
Last updated on this site: 15 Jun 2023
Description of update: C.I.z Safety, efficacy, pharmacovigilance changes
Type IA (C.1.z) variation to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.
SmPC sections updated: 4.4, 4.8, 10.
Last updated on this site: 15 Jun 2023
Description of update: C.I.z Safety, efficacy, pharmacovigilance changes
Type IA (C.1.z) variation to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.
PIL sections updated: 2, 4, 6.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
SmPC section(s) updated – 2, 10.
Last updated on this site: 13 Jul 2023
Description of updates: Grouped Variation
Variation type: IAin, A.3: To register a change to the active substance name from Atorvastatin calcium trihydrate to Atorvastatin calcium (to comply with current PhEur monograph). Consequentially, the PIL, labelling and section 2 of the SPC has been updated.
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 03, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 02).
Variation type: IA, B.III.1.a.2: To register an updated European Certificate of Suitability, R1-CEP 2010-366-Rev 04, for the active substance Atorvastatin Calcium, manufactured at Centrient Pharmaceuticals India Private Limited, Bhai Mohan Singh Nagar, District Nawanshahr India-144 533 Toansa, Punjab (replacing the previous certificate R1-CEP 2010-366-Rev 03).
NB: Approved re-test period: The re-test period of the substance is 5 years if stored in a polyethylene bag, in a laminated aluminium bag, placed in a polyethylene drum.
Variation type: IA, B.III.2.b: To update the specification for Atorvastatin calcium to register the Ph.Eur general chapter 2.4.20 for sodium testing, in house method 5492 for particle size testing and the updated Ph. Eur limits for assay, related substances, enantiomeric purity and water testing. It is proposed to remove ID C (water) and to amend the calcium test from ID D to ID C in line with the updates in Ph.Eur supplement 10.7.
PIL section(s) updated – 6.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 15 Jun 2023
Description of update: C.I.z Safety, efficacy, pharmacovigilance changes
Type IA (C.1.z) variation to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.
SmPC sections updated: 4.4, 4.8, 10.
Last updated on this site: 15 Jun 2023
Description of update: C.I.z Safety, efficacy, pharmacovigilance changes
Type IA (C.1.z) variation to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.
PIL sections updated: 2, 4, 6.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintThe controller of your personal data is Accord-UK Ltd, with its registered office at Whiddon Valley, Barnstaple, EX32 8NS, United Kingdom. Your personal data will be processed for the purpose of correspondence, handling your enquiry and/or taking appropriate steps to conclude and perform the contract between the controller and the company you represent. For more information on the processing of personal data, including your rights, please see our Privacy Policy available on our website: https://www.accord-healthcare.com/uk/
A Summary of Product Characteristics (SmPC) is a document describing the properties and the approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively, and are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) in the EU.
A Patient Information Leaflet (PIL) is a document included in the package of a medication that provides specific information about that medication and its use. It includes information about dose and administration of the medicine, warnings and precautions and potential side effects.
All medicines have both risks and benefits of treatment, it is important to minimise the risks. Some products will have specific activities or materials that companies need to do or provide in order to make the risks of treatment with the medicine as small as possible, these are known as Risk Minimisation Measures or RMMs. Examples of risk minimisation measures could include written guides for patients or healthcare professionals, an alert card for patients or a requirement to ask specific questions if a patient experiences a particular adverse effect of treatment.
Search for the relevant product and click on it. Here, you will see all available strengths and their associated documents. Click on one of the links under the “Product Documentation” header to open the document in a new window in your browser. Right click on the document in this new window and select “Print” from the drop-down menu that appears by your cursor.
There are two ways to search for a product on the Accord Product Website. The first is to use the search bar at the top of the screen to search by product name or PL number (e.g. 0142/0456). The second way to search for a product is to look at our full list by clicking on “Products” at the top of the screen, or by clicking one of the letter icons at the top of every page.
A generic drug is a medicine that is developed to be the same as a medicine that has already been authorised, and which is usually branded. Generic medications contain the same active ingredient as the original branded medication and work the same way but may differ in shape or size. Most Accord medications are generic medications.
A biosimilar medication is a biological medication (one whose active substance is made by a living organism) that is highly similar to an already approved biological medicine. These biosimilar medications are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all medicines.
As well as Accord products, Accord also sells medications that are licenced by other pharmaceutical companies. If you need information about a product, you may need to check who the marketing authorisation holder is, and this will be on the packaging. You may need to contact the other company for an answer to your query.
All Accord medicinal products have a Product Licence (PL) number. This is unique to each type of medicine and will differ by the strength of each medicine as well. PL numbers are listed under each product on this website. To find your medicine’s PL number, look on the carton or bottle label, as this will have the PL number on it (usually on the back – check beneath the dispensing label if necessary).
Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. The black triangle will appear on the Summary of Product Characteristics and the Patient Information Leaflet. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk for how to report side effects or report to Accord by clicking on the Report a side effect or a product complaint button, or emailing medinfo@accord-healthcare.com.
For any further assistance, please get in touch.