Granpidam
Authorised
This medicine is authorised for use in the European Union
sildenafil
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs). In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Granpidam contains the active substance sildenafil. It is a ‘generic medicine’. This means that Granpidam is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Revatio.
Granpidam can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Granpidam is available as tablets (20 mg). In adults, Granpidam is taken at a dose of 20 mg three times a day. Lower doses of Granpidam may be needed in patients taking some medicines that affect the way Granpidam is broken down in the body.
In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used. In children weighing less than 20 kg the maximum recommended dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given. For lower doses, other medicines containing sildenafil should therefore be used.
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When it is blocked, a substance called ‘cyclic guanine monophosphate’ (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels. In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafil-containing tablet. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. In this case Granpidam was not compared with the reference product Revatio, but with Viagra. This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.
Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Granpidam was considered to be comparable to Revatio. Therefore, the CHMP’s view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk. The Committee recommended that Granpidam be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Granpidam on 14 November 2016.
For more information about treatment with Granpidam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0015
30/03/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Granpidam
- Active substance
- sildenafil citrate
- International non-proprietary name (INN) or common name
- sildenafil
- Therapeutic area (MeSH)
- Hypertension, Pulmonary
- Anatomical therapeutic chemical (ATC) code
- G04BE03
Pharmacotherapeutic group
UrologicalsTherapeutic 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.
News on Granpidam
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