Granpidam

RSS

sildenafil

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

Overview

This is a summary of the European public assessment report (EPAR) for Granpidam. 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 Granpidam.

For practical information about using Granpidam, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/02/2017

Authorisation details

Product details
Name
Granpidam
Agency product number
EMEA/H/C/004289
Active substance
sildenafil citrate
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
G04BE03
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
14/11/2016
Contact address
Sage House
319 Pinner Road
North Harrow
Middlesex HA1 4HF
United Kingdrom

Product information

17/01/2017 Granpidam - EMEA/H/C/004289 - IAIN/0001/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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

Pharmacotherapeutic group

UROLOGICALS

Therapeutic indication

Adults
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

Paediatric population
Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

Assessment history

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