PIL - Lisinopril 2.5mg, 5mg, 10mg, 20mg Tablets (PL 0142/0466, 0467, 0468, 0469): Change history
View Patient Information Leaflet (PIL - Lisinopril 2.5mg, 5mg, 10mg, 20mg Tablets (PL 0142/0466, 0467, 0468, 0469))
Last updated on this site: 27 Jun 2023
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
PIL sections updated – Header, 1, 2, 4, 5 and 6.
Last updated on this site: 27 Jun 2023
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
PIL sections updated – Header, 1, 2, 4, 5 and 6.
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Changes: (Updated: 27 Jun 2023)
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
PIL sections updated – Header, 1, 2, 4, 5 and 6.
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Changes: (Updated: 13 Jan 2023)
Website administration update.
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Changes: (Updated: 13 Jan 2023)
Website administration update.
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Changes: (Updated: 21 Sep 2022)
Initial upload