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Intended for UK patients and members of the public

Cinacalcet Accordpharma 60mg Film-coated Tablets

Cinacalcet Accordpharma 60mg Film-coated Tablets

PL Number:
PLGB 20075/1413
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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 PIL is updated.

  • 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.

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

For any further assistance, please get in touch.

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