PIL- Tacrolimus Accord 0.1% Ointment: Change history
View Patient Information Leaflet (PIL- Tacrolimus Accord 0.1% Ointment)
Last updated on this site: 20 May 2024
Description of update:
To update SmPC sections 4.4, 4.8 and PIL section 4 information in line with the information of Reference product (Protopic 0.1 % ointment; MAH: LEO Pharma A/S, Denmark; EMA procedure number: EMEA/H/C/000374) for Tacrolimus Accord 0.1% ointment. In addition, there are minor editorial updates to SmPC sections 4.4, 4.8 and PIL, a QRD update to the PIL and removal of the country table from the PIL.
PIL sections updated: 2, 4 and 6.
Last updated on this site: 20 May 2024
Description of update:
To update SmPC sections 4.4, 4.8 and PIL section 4 information in line with the information of Reference product (Protopic 0.1 % ointment; MAH: LEO Pharma A/S, Denmark; EMA procedure number: EMEA/H/C/000374) for Tacrolimus Accord 0.1% ointment. In addition, there are minor editorial updates to SmPC sections 4.4, 4.8 and PIL, a QRD update to the PIL and removal of the country table from the PIL.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 20 May 2024)
Description of update:
To update SmPC sections 4.4, 4.8 and PIL section 4 information in line with the information of Reference product (Protopic 0.1 % ointment; MAH: LEO Pharma A/S, Denmark; EMA procedure number: EMEA/H/C/000374) for Tacrolimus Accord 0.1% ointment. In addition, there are minor editorial updates to SmPC sections 4.4, 4.8 and PIL, a QRD update to the PIL and removal of the country table from the PIL.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 25 Mar 2024)
Description of update: To update section 4.4 of the SmPC and section 2 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUSA procedure EMEA/H/C/PSUSA/00002840/202303.
PIL sections updated: 2 & 6.
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Changes: (Updated: 22 Sep 2022)
initial upload