Talmanco (previously Tadalafil Generics)

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tadalafil

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 07/07/2017

Authorisation details

Product details
Name
Talmanco (previously Tadalafil Generics)
Agency product number
EMEA/H/C/004297
Active substance
tadalafil
International non-proprietary name (INN) or common name
tadalafil
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
G04BE08
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
09/01/2017
Contact address

117 Allee des Parcs
69800
Saint-Priest
France

Product information

04/06/2017 Talmanco (previously Tadalafil Generics) - EMEA/H/C/004297 - IB/0002/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

UROLOGICALS

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.

Assessment history

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