SmPC- Naproxen 500mg Gastro-resistant Tablets: Change history

Description of update:

1. IB, B.II.b.3.z   To register a change in the manufacturing process of the finished product by removing the polishing step and making some editorial corrections. Consequently, section 6.1 of the SmPC and the PIL has been updated. Also editorial corrections to M3.2.P.3.3 Manufacturing Process and Process Controls (250mg, 375mg, 500mg dosage strengths) to correct the name for Lactose in M3.2.P.3.3 to reflect what is registered in M3.2.P.1, M3.2.P.3.2, leaflet and SmPCs.            

2. IB, B.II.b.3.z   To register a change in the manufacturing formula of the finished product by deletion of historical references in M3.2.P.3.2 Batch Formula to 19%w/w coating weight gain (as not in line with M3.2.P.3.3 and M3.2.P.1 and to reflect current practice; 17%w/w coating weight gain is correct). Also editorial corrections to M3.2.P.3.2 Batch Formula (250mg, 375mg, 500mg dosage strengths):

               1. Consequential correction of historical typographical errors for Crospovidone content from 9.75kg to 3.77kg.

               2. Consequential correction of historical typographical errors for nomenclature of Eudragit L 100-55 from Coplymer to Copolymer.

1. IB C.I.2.a     To update section 4.6 of the SmPC to bring in line with the reference product Naprosyn 250mg tablets (PL 43252/0004, MAH: Atnahs Pharma UK Ltd). Consequently the PIL has been updated. Additional typographical updates made in the PIL.

SmPC Sections updated: 4.6, 6.1 and 10.

Website administration update

initial upload