Page contentsKey factsDecisionKey facts Active Substance Finasteridetadalafil Therapeutic area Other Decision number P/0461/2022 PIP number EMEA-003261-PIP01-22 Pharmaceutical form(s) All pharmaceutical forms Condition(s) / indication(s) Treatment of patients with benign prostatic hyperplasia Route(s) of administration All routes of administration Contact for public enquiries Adamed Pharma S.A.E-mail: RA-EU@adamed.comTel: +48 227327700 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 28/10/2022DecisionP/0461/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for finasteride / tadalafil (EMEA-003261-PIP01-22)AdoptedReference Number: EMA/790520/2022 English (EN) (210.6 KB - PDF)First published: 28/09/2023ViewShare this page