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PIL - Pregabalin Accord 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Hard Capsules: Change history

  • Description of update: To update sections 4.4, 4.8, 4.9 and 5.3 of the SmPC in line with reference product, Lyrica hard capsules updated with procedure outcome of EMEA/H/C/WS2168; MAH: Upjohn EESV, Netherlands, EMEA/H/C/WS2261; MAH: Upjohn EESV, Netherlands and EMEA/H/C/WS2293; MAH: Upjohn EESV, Netherlands. Consequently, the PIL has been updated.

    PIL sections updated: 2, 4, 6.

    • Changes: (Updated: 27 Mar 2023)

      Description of update: To update sections 4.4, 4.8, 4.9 and 5.3 of the SmPC in line with reference product, Lyrica hard capsules updated with procedure outcome of EMEA/H/C/WS2168; MAH: Upjohn EESV, Netherlands, EMEA/H/C/WS2261; MAH: Upjohn EESV, Netherlands and EMEA/H/C/WS2293; MAH: Upjohn EESV, Netherlands. Consequently, the PIL has been updated.

      PIL sections updated: 2, 4, 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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