The previous version ommited information regarding warnings updated on glaucoma, feelings of aggression, anger, agitation and irritablity, contains sodium, false positives for methadone in urinalysis. Mydrasis, insomnia, agitation, and agression are added to adverse events. All these information were approved in July 2020 and have been placed back in the following sections:

• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.8 - Undesirable effects

Editorial correction on section 4.2 Paediatric Population

[...]7-118 years[...] to [...]7-11 years[...]

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.