Mysildecard

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Questions & Answers

On 28 July 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Mysildecard, intended for the treatment of pulmonary arterial hypertension. The applicant for this medicinal product is MYLAN S.A.S.

Mysildecard will be available as 20 mg film-coated tablets. The active substance of Mysildecard is sildenafil, a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5) (ATC code: G04BE03). Sildenafil increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with pulmonary arterial hypertension this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.

Mysildecard is a generic of Revatio, which has been authorised in the EU since 28 October 2005. Studies have demonstrated the satisfactory quality of Mysildecard and its bioequivalence to Viagra, a sildenafil-containing medicine with the same qualitative composition as Revatio. A question and answer document on generic medicines can be found here.

The full indication is:

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.”

It is proposed that Mysildecard be prescribed by physicians experienced in the treatment of pulmonary arterial hypertension.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. 

Name Language First published Last updated
CHMP summary of positive opinion for Mysildecard (English only) 2016-08-03  

Key facts

Product details for Mysildecard
NameMysildecard
INN or common name

sildenafil

Therapeutic area Hypertension, Pulmonary
Active substance

sildenafil citrate

Date opinion adopted28/07/2016
Company name

MYLAN S.A.S

StatusPositive
Application typeInitial authorisation