List of nationally authorised medicinal products
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1 11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction provided the source is acknowledged.
2 Calcitonin Novartis IE/H/0117/001 & IE/H/0117/ & Novartis Pharma Gmbh Austria Calcitonin Novartis IE/H/0117/ Novartis Pharma Gmbh Austria Calcitonin Novartis IE/H/0117/ Novartis Pharma Gmbh Austria Calcitonin Sandoz Hexal Ag Germany Calcitonina Hubber Meda Pharma S.A.U. Spain Calcitonina Hubber Meda Pharma S.A.U. Spain Calcitonina Sandoz IE/H/0117/ /M Novartis Farma S.P.A. Italy Calcitonina Sandoz IE/H/0117/ /M Novartis Farma S.P.A. Italy Sociedade De Produtos Farmaceuticos Calcitonina Wander IE/H/0122/ Wander, Lda.* Karil IE/H/0117/ Novartis Pharma Gmbh Germany Karil IE/H/0122/ /00/06/0049 Novartis Pharma Gmbh Luxembourg Karil IE/H/0122/ Novartis Pharma Gmbh Germany Miacalcic 088/02001 Malta Miacalcic 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 BE Novartis Pharma N.V. Belgium Miacalcic BE 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
3 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/ & Novartis (Hellas) S.A.C.I. Greece Novartis Farma - Produtos Farmacêuticos Miacalcic IE/H/0117/ & S.A. Miacalcic IE/H/0117/ 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/ Novartis Healthcare A/S Denmark & & Miacalcic IE/H/0117/ & Novartis (Hellas) S.A.C.I. Greece Miacalcic IE/H/0117/ Novartis Farmacéutica S.A. Spain Miacalcic IE/H/0117/003 / IE/H/117/ / Novartis Norge As Norway Miacalcic IE/H/0117/ Novartis Finland Oy Finland Miacalcic IE/H/0117/ Novartis Healthcare A/S Iceland Miacalcic IE/H/0117/ 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/ & & & Novartis Pharma S.A.S. France Miacalcic IE/H/0117/004 BE Novartis Pharma N.V. Belgium EMA/4301/2016 Page 3/5
4 Miacalcic IE/H/0117/004 BE Novartis Pharma N.V. Belgium Miacalcic IE/H/0117/004 PA 13/40/1 Miacalcic IE/H/0117/004 PL 00101/0202 Miacalcic / миакалцик Novartis Pharma Gmbh Bulgaria Miacalcic Nasal R/7916 Novartis Pharma Gmbh Poland Miacalcic Nasal IE/H/0117/ Novartis Finland Oy Finland Miacalcic Nasal IE/H/0117/ 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 Novartis Pharma Gmbh Bulgaria Miakaril IE/H/0122/001 PA 13/94/1 Oseototal IE/H/0122/ Novartis Farmacéutica S.A. Spain Osseocalcina IE/H/0123/ & Laboratorio Normal-Produtos Farmaceuticos, Lda Ostulex IE/H/0123/001 PA 13/93/1 Calsyn & & & Sanofi-Aventis France France Calsyn & & & Sanofi-Aventis France France Calsynar 50 UI Sanofi-Aventis SA Spain Calsynar 100 UI Sanofi-Aventis SA Spain Calsynar 200 UI Sanofi-Aventis SA Spain Calsynar 200 UI Sanofi-Aventis SA Spain Calsynar ; ; ; Sanofi-Aventis AEBE Greece Calsynar ; ; Sanofi-Aventis AEBE Greece Calsynar Sanofi-Aventis AEBE Greece EMA/4301/2016 Page 4/5
5 Calcitar Sanofi-aventis Produtos Farmaceuticos S.A. Calcyn Sanofi-aventis Produtos Farmaceuticos S.A. Ospor IE/H/0123/ Laboratorios Padró, S.A. Spain EMA/4301/2016 Page 5/5
List of nationally authorised medicinal products
5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
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3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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