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EMA Product

Talmanco (previously Tadalafil Generics)

Product approved by European Medicines Agency (EU)

Basic Information

Talmanco (previously Tadalafil Generics)

Regulatory Information

EMEA/H/C/004297

Authorised

January 9, 2017

November 10, 2016

9

April 9, 2025

Company Information

Ireland

Damastown Industrial Park Dublin 15

VIATRIS PHARMA LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Talmanco. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Talmanco. For practical information about using Talmanco, patients should read the package leaflet or contact their doctor or pharmacist.

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