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SmPC - Atorvastatin 20mg Film-coated Tablets (20075/0552): Change history

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  • View Summary of Product Characteristics (SmPC - Atorvastatin 20mg Film-coated Tablets (20075/0552))

    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.

    View change history

    • Changes: (Updated: 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.

    • Changes: (Updated: 28 Jun 2023)

      Variation Description:

      IB C.I.2.a: To update sections 4.4, 4.5, 4.6, 4.8, 5.1 and 5.2 of the SmPC in line with the reference product Lipitor 10, 20, 40mg film-coated tablets (PL 50622/0036, 0039, 0041-DE/H/0109)

      IB C.I.3.a: To update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the leaflet in line with the PRAC recommendation - Myasthenia gravis (EPITT no 19822).

      Additional updates:

      • To update the ATC code in line with the WHO ATC code Index, consequently section 5.1 of the SmPC has been updated

      • To update sections 4.8 and 5.1 of the SmPC in line with the QRD updates

      • To update section 4.8 of the SmPC in line with MedDRA

      • Additionally, editorials changes have been made to sections 4.4, 4.5, 5.1 and 5.2 of the SmPC and the leaflet.

      SmPC sections updated – 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.

    • Changes: (Updated: 27 Sep 2022)

      Initial upload

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