11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill Place Canary Wharf London E14 5EU 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, 2016. Reproduction provided the source is acknowledged.
Calcitonin Novartis IE/H/0117/001 & IE/H/0117/002 1-20665 & 1-23961 Novartis Pharma Gmbh Austria Calcitonin Novartis IE/H/0117/003 16880 Novartis Pharma Gmbh Austria Calcitonin Novartis IE/H/0117/004 1-18623 Novartis Pharma Gmbh Austria Calcitonin Sandoz 2126592 26592.00.00 Hexal Ag Germany Calcitonina Hubber 57.064 Meda Pharma S.A.U. Spain Calcitonina Hubber 59486 Meda Pharma S.A.U. Spain Calcitonina Sandoz IE/H/0117/003 023704 202/M Novartis Farma S.P.A. Italy Calcitonina Sandoz IE/H/0117/004 023704 214/M Novartis Farma S.P.A. Italy Sociedade De Produtos Farmaceuticos Calcitonina Wander IE/H/0122/001 2637783 Wander, Lda.* Karil IE/H/0117/003 4104.00.00 Novartis Pharma Gmbh Germany Karil IE/H/0122/001 0135/00/06/0049 Novartis Pharma Gmbh Luxembourg Karil IE/H/0122/001 49029.00.00 Novartis Pharma Gmbh Germany Miacalcic 088/02001 Malta Miacalcic 18426 Cyprus Miacalcic 5363-I-561/10 Novartis Pharma Gmbh Slovenia Miacalcic 5363-I-562/10 Novartis Pharma Gmbh Slovenia Miacalcic 5400/2005/01 Novartis Pharma Gmbh Romania Miacalcic 56/0014/75-S Novartis, S.R.O. Slovakia Miacalcic 56/0014/75-S Novartis, S.R.O. Slovakia Miacalcic 56/014/75-A/C & 56/014/75-B/C Novartis, S.R.O. Czech Republic Miacalcic 56/573/97-C Novartis, S.R.O. Czech Republic Miacalcic BE168524 Novartis Pharma N.V. Belgium Miacalcic BE173031 Novartis Pharma N.V. Belgium Miacalcic OGYI-T-1342/01 Novartis Hungária Kft. Pharma Hungary Miacalcic OGYI-T-1342/02 Novartis Hungária Kft. Pharma Hungary EMA/255959/2016 Page 2/5
Miacalcic OGYI-T-1342/03 & OGYI-T-1342/04 Novartis Hungária Kft. Pharma Hungary Miacalcic PL 00101/0203 Miacalcic R/1193 & R/1194 Novartis Poland Sp. Z O. O. Poland Miacalcic IE/H/0117/001 198430301 & 198430302 Novartis (Hellas) S.A.C.I. Greece Novartis Farma - Produtos Farmacêuticos Miacalcic IE/H/0117/001 3068384 & 8668525 S.A. Miacalcic IE/H/0117/001 61699 Novartis Farmacéutica S.A. Spain Miacalcic IE/H/0117/001 PA 13/40/5 Miacalcic IE/H/0117/001 PL 00101/0586 Miacalcic IE/H/0117/002 PA 13/40/4 Miacalcic IE/H/0117/003 06594 Novartis Healthcare A/S Denmark 198430101 & 198430102 & Miacalcic IE/H/0117/003 198430103 & 198430104 Novartis (Hellas) S.A.C.I. Greece Miacalcic IE/H/0117/003 56198 Novartis Farmacéutica S.A. Spain Miacalcic IE/H/0117/003 / IE/H/117/001 6184 / 95-3370 Novartis Norge As Norway Miacalcic IE/H/0117/003 7325 Novartis Finland Oy Finland Miacalcic IE/H/0117/003 761970 Novartis Healthcare A/S Iceland Miacalcic IE/H/0117/003 9290 Novartis Sverige Ab Sweden Miacalcic IE/H/0117/003 PA 13/40/2 Miacalcic IE/H/0117/003 PL 00101/0095R Miacalcic IE/H/0117/004 3400933020323 & 3400957383251 & 3400957383312 & 3400957383480 Novartis Pharma S.A.S. France Miacalcic IE/H/0117/004 BE126901 Novartis Pharma N.V. Belgium EMA/4301/2016 Page 3/5
Miacalcic IE/H/0117/004 BE126901 Novartis Pharma N.V. Belgium Miacalcic IE/H/0117/004 PA 13/40/1 Miacalcic IE/H/0117/004 PL 00101/0202 Miacalcic / миакалцик 20000833 Novartis Pharma Gmbh Bulgaria Miacalcic Nasal R/7916 Novartis Pharma Gmbh Poland Miacalcic Nasal IE/H/0117/001 15421 Novartis Finland Oy Finland Miacalcic Nasal IE/H/0117/001 15678 Novartis Healthcare A/S Denmark Miacalcic Nasal IE/H/0117/001 IS/1/01/112/01 Novartis Healthcare A/S Iceland Miacalcic Nasal/ миакалцик назал 20000525 Novartis Pharma Gmbh Bulgaria Miakaril IE/H/0122/001 PA 13/94/1 Oseototal IE/H/0122/001 62538 Novartis Farmacéutica S.A. Spain Osseocalcina IE/H/0123/001 3068483 & 8727222 Laboratorio Normal-Produtos Farmaceuticos, Lda Ostulex IE/H/0123/001 PA 13/93/1 Calsyn 340 657-6 & 343 506-9 & 343 507-5 & 343 508-1 Sanofi-Aventis France France Calsyn 340 658-2 & 343 502-3 & 343 504-6 & 343 505-2 Sanofi-Aventis France France Calsynar 50 UI 57246 Sanofi-Aventis SA Spain Calsynar 100 UI 54532 Sanofi-Aventis SA Spain Calsynar 200 UI 59213 Sanofi-Aventis SA Spain Calsynar 200 UI 62183 Sanofi-Aventis SA Spain Calsynar 205810101; 205810102; 205810103; 205810104 Sanofi-Aventis AEBE Greece Calsynar 205810201; 205810202; Sanofi-Aventis AEBE Greece Calsynar 205810401 Sanofi-Aventis AEBE Greece EMA/4301/2016 Page 4/5
Calcitar 200 4470985 Sanofi-aventis Produtos Farmaceuticos S.A. Calcyn 200 4471082 Sanofi-aventis Produtos Farmaceuticos S.A. Ospor IE/H/0123/001 62540 Laboratorios Padró, S.A. Spain EMA/4301/2016 Page 5/5