PIL - Pravastatin Sodium 10mg, 20mg, 40mg Tablets: Change history
View Patient Information Leaflet (PIL - Pravastatin Sodium 10mg, 20mg, 40mg Tablets)
Last updated on this site: 08 Apr 2024
Description of update: To update section 4.8 of the SmPC and section 4 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/00002500/202303. Additional
PIL sections updated: Introduction, 1, 2, 4, 5 and 6.
Last updated on this site: 08 Apr 2024
Description of update: To update section 4.8 of the SmPC and section 4 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/00002500/202303. Additional
PIL sections updated: Introduction, 1, 2, 4, 5 and 6.
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Changes: (Updated: 08 Apr 2024)
Description of update: To update section 4.8 of the SmPC and section 4 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/00002500/202303. Additional
PIL sections updated: Introduction, 1, 2, 4, 5 and 6.
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Changes: (Updated: 16 Nov 2023)
Description of update:
Update of the sections 4.4, 4.5, 4.8 and 5.3 of SmPC and section 2,3 and 4 of PIL in line with the information of Reference product (SELECTIN 10mg/20 mg/40mg compresse; EU procedure number: FR/H/0252/001-003; MAH: Bristol-Myers Squibb S.r.l., Italy) for Pravastatin Sodium 10mg/20mg/40mg Tablets. Additionally, updated of the sections 4.4, 4.5 of SmPC and section 2 of PIL with editorial changes, section 2 of PIL with QRD template related changes.
Type IA: B.II.b.2.a - replacement of batch control/testing site from Galenicum Health, S.L. Avda. Cornella 144, 7º-1ª Edificio, Lekla, Esplugues De Llobregat 08950 Barcelona, Spain to Galenicum Health, S.L.U. Sant Gabriel, 50, Esplugues de Llobregat, 08950 Barcelona Spain.
Type IA: A.7 - deletion of Galenicum Health, S.L., Avda. Cornella 144, 7º-1ª Edificio, Lekla, Esplugues De Llobregat 08950, Barcelona, Spain as Batch Release site.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 19 Jun 2023)
Description of update: Type IAin: C.I.z - to update SmPC section 4.4, 4.8 and PIL section 2 and 4 to include adverse reactions with a frequency not known: myasthenia gravis and ocular myasthenia as per PRAC recommendations on signals adopted at the 9-12 January 2023.
PIL sections updated: 2, 4, 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload