SmPC- Cinacalcet Accordpharma 60mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Cinacalcet Accordpharma 60mg Film-coated Tablets)
Last updated on this site: 06 Oct 2026
Type IB (Q.II.b.5.z) variation application for change in hardness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.b.5.z) variation application for change in thickness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.d.1.c) variation application for addition of N-Nitroso Cinacalcet (by LCMS) test in drug product specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.e.1.a.1) variation application for change in immediate packaging of the finished product; addition of Alu-Alu blister pack as primary packaging for finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.z) variation application for addition of Triple Laminated Aluminium Bag as bulk pack/transportation pack for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.d.1.z) variation application for change in limit of Loss on drying test in drug product release specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.a.3.b.z) variation application for change in composition of finished product to introduce a new excipient Cysteine hydrochloride, the quantity of which is compensated by an equivalent decrease of the quantity of excipient Microcrystalline cellulose for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.a) variation application for minor changes in manufacturing process of finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Consequently, the SmPC is updated.
Last updated on this site: 06 Oct 2026
Type IB (Q.II.b.5.z) variation application for change in hardness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.b.5.z) variation application for change in thickness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.d.1.c) variation application for addition of N-Nitroso Cinacalcet (by LCMS) test in drug product specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.e.1.a.1) variation application for change in immediate packaging of the finished product; addition of Alu-Alu blister pack as primary packaging for finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.z) variation application for addition of Triple Laminated Aluminium Bag as bulk pack/transportation pack for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.d.1.z) variation application for change in limit of Loss on drying test in drug product release specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.a.3.b.z) variation application for change in composition of finished product to introduce a new excipient Cysteine hydrochloride, the quantity of which is compensated by an equivalent decrease of the quantity of excipient Microcrystalline cellulose for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.a) variation application for minor changes in manufacturing process of finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Consequently, the SmPC is updated.
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Changes: (Updated: 06 Oct 2026)
Type IB (Q.II.b.5.z) variation application for change in hardness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.b.5.z) variation application for change in thickness limit at compression stage during the manufacturing of finished product for Cinacalcet 30mg Tablets.
Type IB (Q.II.d.1.c) variation application for addition of N-Nitroso Cinacalcet (by LCMS) test in drug product specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.e.1.a.1) variation application for change in immediate packaging of the finished product; addition of Alu-Alu blister pack as primary packaging for finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.z) variation application for addition of Triple Laminated Aluminium Bag as bulk pack/transportation pack for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.d.1.z) variation application for change in limit of Loss on drying test in drug product release specification for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.a.3.b.z) variation application for change in composition of finished product to introduce a new excipient Cysteine hydrochloride, the quantity of which is compensated by an equivalent decrease of the quantity of excipient Microcrystalline cellulose for Cinacalcet 30mg/60mg/90mg film coated tablets.
Type IB (Q.II.b.3.a) variation application for minor changes in manufacturing process of finished product for Cinacalcet 30mg/60mg/90mg film coated tablets.
Consequently, the SmPC is updated.
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Changes: (Updated: 04 Feb 2025)
Renewal approval
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Changes: (Updated: 20 Sep 2022)
Initial upload