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Intended for UK patients and members of the public

Atorvastatin Tablets

Active Ingredients

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 complaint

Atorvastatin 10mg Film-coated Tablets (PL 20075/0551)

PL Number:
20075/0551
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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 complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Atorvastatin 20mg Film-coated Tablets (PL 20075/0489)

PL Number:
20075/0489
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

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 complaint

Atorvastatin 20mg Film-coated Tablets (PL 20075/0552)

PL Number:
20075/0552
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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 complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Atorvastatin 40mg Film-coated Tablets (PL 20075/0490)

PL Number:
20075/0490
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

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 complaint

Atorvastatin 40mg Film-coated Tablets (PL 20075/0553)

PL Number:
20075/0553
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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 complaint

Atorvastatin 80mg Film-coated Tablets (PL 20075/0491)

PL Number:
20075/0491
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

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 complaint

General FAQs

For any further assistance, please get in touch.

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