PIL - Kentera 3.9mg/24h Transdermal Patch: Change history
View Patient Information Leaflet (PIL - Kentera 3.9mg/24h Transdermal Patch)
Last updated on this site: 01 Aug 2023
To update section 4.2 of the SmPC and PIL in line with EMEA/H/C/PSUSA/00002253/202207 recommendation not to divide or cut into the patches.
In addition, the following updates have been made to the SmPC and PIL:
Update to SmPC section 4.2, with movement of text and addition of subheadings ‘Posology’ and ‘Method of administration’ in line with QRD.
Deletion of biperiden from SmPC section 4.5 and PIL; this drug is not available in the UK.
Update to SmPC section 4.6 heading and addition of subheadings ‘Pregnancy’ and ‘Breast-feeding’ in line with QRD.
Addition of Fertility subsection to SmPC section 4.6 in line with the "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)".
Update to SmPC section 5.1 pharmacotherapeutical group in line with the WHO ATC Index.
Editorial updates to SmPC sections 4.5, 5.1 and PIL.
QRD updates throughout the PIL.
Last updated on this site: 01 Aug 2023
To update section 4.2 of the SmPC and PIL in line with EMEA/H/C/PSUSA/00002253/202207 recommendation not to divide or cut into the patches.
In addition, the following updates have been made to the SmPC and PIL:
Update to SmPC section 4.2, with movement of text and addition of subheadings ‘Posology’ and ‘Method of administration’ in line with QRD.
Deletion of biperiden from SmPC section 4.5 and PIL; this drug is not available in the UK.
Update to SmPC section 4.6 heading and addition of subheadings ‘Pregnancy’ and ‘Breast-feeding’ in line with QRD.
Addition of Fertility subsection to SmPC section 4.6 in line with the "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)".
Update to SmPC section 5.1 pharmacotherapeutical group in line with the WHO ATC Index.
Editorial updates to SmPC sections 4.5, 5.1 and PIL.
QRD updates throughout the PIL.
-
Changes: (Updated: 01 Aug 2023)
To update section 4.2 of the SmPC and PIL in line with EMEA/H/C/PSUSA/00002253/202207 recommendation not to divide or cut into the patches.
In addition, the following updates have been made to the SmPC and PIL:
Update to SmPC section 4.2, with movement of text and addition of subheadings ‘Posology’ and ‘Method of administration’ in line with QRD.
Deletion of biperiden from SmPC section 4.5 and PIL; this drug is not available in the UK.
Update to SmPC section 4.6 heading and addition of subheadings ‘Pregnancy’ and ‘Breast-feeding’ in line with QRD.
Addition of Fertility subsection to SmPC section 4.6 in line with the "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)".
Update to SmPC section 5.1 pharmacotherapeutical group in line with the WHO ATC Index.
Editorial updates to SmPC sections 4.5, 5.1 and PIL.
QRD updates throughout the PIL.
-
Changes: (Updated: 22 Sep 2022)
Initial upload