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Revatio® (sildenafil citrate): Safety Information regarding Revatio® tablets for the treatment of pulmonary arterial hypertension (PAH)

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Date: 07 October 2014

Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of new safety information from a clinical trial regarding use of Revatio® for the treatment of pulmonary arterial hypertension (PAH) in paediatric patients.The package insert will be updated by Pfizer (Malaysia) Sdn. Bhd. with this new information. Please refer to the DHPC for full details. This safety issue was also featured in an NPCB publication, Reaksi Drug Safety News January 2015.

 

National Pharmaceutical Regulatory Agency (NPRA)

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