SmPC - Granpidam 20 mg Film-coated Tablets: Change history

Description of update: To update sections 4.4, 4.8 and 5.1 of the SmPC in-line with reference product (Revatio 20 mg film-coated tablets; EU procedure number: EMEA/H/C/000638/N/0104; MAH: Upjohn EESV) for Granpidam 20mg Film-coated Tablets. Note that section 4.4 of the SmPC has been updated for excipient warning as per the guideline on "Excipients in the Label and Package Leaflet of Medicinal Products for Human Use"

SmPC sections updated: 4.4, 4.8, 5.1, 10.

Update of Sections 4.8 and 5.1 of the SmPC to include long-term safety data in adults for the approved dose, and evidence of safe and effective use in adults in higher than recommended doses, based on Study A1481324; a multinational, multicentre randomized, double-blind, parallel-group study in 385 adults with Pulmonary Arterial Hypertension (PAH) undertaken to assess the effects of different dose levels of oral sildenafil on mortality in line with the reference product Revatio II-98.

4.8 and 5.1

Initial upload