SmPC- Tacrolimus Accord 0.1% Ointment: Change history
View Summary of Product Characteristics (SmPC- 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.
SmPC Sections updated: 4.4, 4.8 and 10.
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.
SmPC Sections updated: 4.4, 4.8 and 10.
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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.
SmPC Sections updated: 4.4, 4.8 and 10.
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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.
SmPC Sections updated: 4.4 & 10.
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Changes: (Updated: 20 Nov 2023)
Description of update: Renewal. Renewal date: 03/11/2023.
SmPC Sections updated: 10 only.
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Changes: (Updated: 24 May 2023)
Description of update:
• B.II.f).1.a). 1 As packaged for sale
1) B.II.f.1.a.1 (Type IAin): To reduce the shelf life of the finished product Tacrolimus ointment 0.1% as packaged for sale, from 36 months to 24 months when stored below 25 °C.
• B.III.1.a). 2 Updated certificate from an already approved manufacturer
2) B.III.1.a.2 (Type IA): To update the Ph. Eur. Certificate of Suitability for Tacrolimus monohydrate from “R0-CEP 2017-257-Rev 01” to “R0-CEP 2017-257-Rev 02” (Biocon API source).
3) B.III.1.a.2 (Type IA): To update the Ph. Eur. Certificate of Suitability for Tacrolimus monohydrate from “ R0-CEP 2017-257-Rev 02” to “ R1-CEP 2017-257-Rev 00” (Biocon API source).
4) B.III.1.a.2 (Type IA): To update the Ph. Eur. Certificate of Suitability for Tacrolimus monohydrate from “R0-CEP 2018-233-Rev 01” to “R0-CEP 2018-233-Rev 02” (Teva API source).
5) B.III.1.a.2 (Type IA): To update the Ph. Eur. Certificate of Suitability for Tacrolimus monohydrate from “R0-CEP 2018-233-Rev 02” to “R0-CEP 2018-233-Rev 03” (Teva API source).
SmPC sections updated: 6.3, 10.
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Changes: (Updated: 22 Sep 2022)
initial upload