16.09.2025 - Notice within the graduated plan procedure (“Stufenplanverfahren”)

With its decision of 9 September 2025, the Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 22 August 2025, C(2025) 5896 final, at national level. With the amendment of the marketing authorisations, the European risk assessment procedure pursuant to Article 31 of Directive 2001/83/EC on medicinal products containing finasteride and dutasteride is concluded.

When submitting the variation to comply with the referral, SKNR 6538 listed in the decision and the keyword ‘Finasteride/Dutasteride - Fulfilment of requirements’ must be included in the variation.
It should also be noted that, in addition to the information contained in the decision on the submission of RMPs for medicinal products containing 1 mg finasteride, the CMDh publications must also be taken into account.

01.09.2025 – European Commission final decision

The risk assessment procedure in accordance with Article 31 of Directive 2001/83/EC on medicinal products containing finasteride and dutasteride was finalised with the publication of the European Commission's decision. According to this decision, the summary of product characteristics and package leaflets of the medicinal products listed in Annex I must be adapted to the scientific knowledge set out in Annex II of the implementing decision in accordance with Annex III.

Note:
The pharmaceutical companies to whom the graduated plan notification will be addressed are requested to notify the changes in the product information with the functional structure number (SKNR) 6538 (keyword ‘Finasteride/Dutasteride - fulfilment of requirements’).

European Commission final decision

20.06.2025 - CMDh position

EMA recommends measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines.

The Agency confirms suicidal thoughts as side effect of finasteride tablets but found no direct link for dutasteride.

On 19 June 2025, the CMDh endorsed measures recommended by EMA’s safety committee, PRAC, to minimise the risk of suicidal ideation (suicidal thoughts) with finasteride and dutasteride medicines. Suicidal ideation was confirmed as a side effect of finasteride 1 and 5 mg tablets by the PRAC, following an EU-wide review of available data on these medicines. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.

08.05.2025 - PRAC recommendation

Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines

Suicidal thoughts confirmed as side effect of finasteride tablets; no direct link found for dutasteride

Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.

04.10.2024 - Procedure started

EMA started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):