SmPC - Kentera 3.9mg/24h Transdermal Patch: Change history

 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.