23March2017.PDF

23 March 2017 EMA/203429/2017 Corr.11 Procedure Management and Business Support Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established as adopted by the CHMP on 23 March 2017 Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1450 EMEA/H/A31/1450/C/003787/0005 1 12 April 2017 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. MA (EU) number (Invented) Strength Pharmaceutical Route of Immediate Packaging Pack size name Form Administration EU/1/14/961/001 Tadalafil Mylan 10 mg Film-coated tablet Oral use blister (PVC/PE/PVdC-Alu) 4 tablets EU/1/14/961/002 Tadalafil Mylan 20 mg Film-coated tablet Oral use blister (PVC/PE/PVdC-Alu) 2 tablets EU/1/14/961/003 Tadalafil Mylan 20 mg Film-coated tablet Oral use blister (PVC/PE/PVdC-Alu) 4 tablets EU/1/14/961/004 Tadalafil Mylan 20 mg Film-coated tablet Oral use blister (PVC/PE/PVdC-Alu) 8 tablets EU/1/14/961/005 Tadalafil Mylan 20 mg Film-coated tablet Oral use blister (PVC/PE/PVdC-Alu) 12 tablets EU/1/14/961/006 Tadalafil Mylan 20 mg Fil