09 March 2017 EMA/169827/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: lovastatin Procedure no.: PSUSA/00010051/201607 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 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. Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where authorisation country) number Number member state product is authorised Lovahexal 10 mg DE/H/4056/001 54351.00.00 HEXAL AG DE DE/H/4056/001 0328607 HEXAL AG LU DE/H/4056/001 0328591 HEXAL AG LU DE/H/4056/001 0328624 HEXAL AG LU DE/H/4056/001 0328611 HEXAL AG LU DE/H/4056/001 0328641 HEXAL AG LU DE/H/4056/001 0328638 HEXAL AG LU DE/H/4056/001 0328655 HEXAL AG LU DE/H/4056/001 0328672 HEXAL AG LU DE/H/4056/001 0328669 HEXAL AG LU DE/H/4056/001 0328686 HEXAL AG LU DE/H/4056/001 0715/02/07/0021 HEXAL AG LU DE/H/2001/001 54354.00.00 1 A PHARMA GMBH DE 58,751 VIFOR PHARMA ESPAÑA, S.L. ES Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten LovaHEXAL 10 mg Tabletten Lovastatin - 1A Pharma 10 mg Tabletten NERGADAN 20 mg comprimidos List of nationally authorised medicinal products EMA/169827/2017 Page 2/3 Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where authorisation country) number Number member state product is authorised 58,751 VIFOR PHARMA ESPAÑA, S.L. ES TAUCOR 20 mg 58757 SIGMA TAU ESPAÑA, S.A. ES TAUCOR 40 mg 60835 SIGMA TAU ESPAÑA, S.A. ES NERGADAN 20 mg comprimidos List of nationally authorised medicinal products EMA/169827/2017 Page 3/3
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