List of nationally authorised medicinal products

Transcription

1 26 October 2017 EMA/663554/2017 Human Medicines Evaluation Division Active substance(s): clodronic acid Procedure No.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 ACIDO CLODRONICO EG 100 mg/3,3 ml soluzione iniettabile Bonefos 400 mg tvrdé kapsuly Bonefos 400 mg tvrdé kapsuly not available EG S.P.A. IT not available 44/0093/89-S BAYER OY SK not available 44/0093/89-S BAYER OY SK Bonefos 400 mg cápsulas not available BAYER HISPANIA SL ES Bonefos 400 mg cápsulas not available BAYER HISPANIA SL ES Bonefos 400 mg capsules not available PL 00010/0521 BAYER PLC UK Bonefos 400 mg capsules not available PL 00010/0521 BAYER PLC UK Bonefos 400 mg capsules. not available MA513/04001 BAYER PLC MT Bonefos 400 mg capsules. not available MA513/04001 BAYER PLC MT Bonefos 400 mg cietās kapsulas Bonefos 400 mg cietās kapsulas Bonefos 400 mg kapseli, kova Bonefos 400 mg kapseli, kova Bonefos 400 mg kapsule, tvrde not available BAYER AG LV not available BAYER AG LV not available 8962 BAYER OY FI not available 8962 BAYER OY FI not available HR-H BAYER DOO HR EMA/663554/2017 Page 2/12

3 Bonefos 400 mg kapsule, tvrde BONEFOS 400 mg Tvrdé tobolky BONEFOS 400 mg Tvrdé tobolky not available HR-H BAYER DOO HR not available 44/093/89-S/C BAYER OY CZ not available 44/093/89-S/C BAYER OY CZ Bonefos 400 mg, capsules not available RVG BAYER BV NL Bonefos 400 mg, capsules not available RVG BAYER BV NL BONEFOS 60 mg/ml, concentraat voor oplossing voor infusie BONEFOS 60 mg/ml, concentraat voor oplossing voor infusie BONEFOS 60 mg/ml, solution à diluer pour perfusion BONEFOS 60 mg/ml, solution à diluer pour perfusion Bonefos 800 mg comprimate filmate not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available 8458/2015/01 BAYER OY RO EMA/663554/2017 Page 3/12

4 Bonefos 800 mg comprimate filmate Bonefos 800 mg comprimidos revestidos por película Bonefos 800 mg comprimidos revestidos por película Bonefos 800 mg film-coated tablets Bonefos 800 mg film-coated tablets Bonefos 800 mg filmdragerade tabletter Bonefos 800 mg filmdragerade tabletter Bonefos 800 mg filmom obalené tablety Bonefos 800 mg filmom obalené tablety Bonefos 800 mg filmsko obložene tablete not available 8458/2015/01 BAYER OY RO not available BAYER PORTUGAL LDA PT not available BAYER PORTUGAL LDA PT not available PA 1410/2/1 BAYER LTD IE not available PA 1410/2/1 BAYER LTD IE not available BAYER AB SE not available BAYER AB SE not available 87/0366/00-S BAYER OY SK not available 87/0366/00-S BAYER OY SK not available H/03/00296/001 BAYER OY SI EMA/663554/2017 Page 4/12

5 Bonefos 800 mg filmsko obložene tablete BONEFOS 800 mg Potahované tablety BONEFOS 800 mg Potahované tablety not available H/03/00296/001 BAYER OY SI not available 44/291/99-C BAYER OY CZ not available 44/291/99-C BAYER OY CZ Bonefos 800 mg tablets not available PL 00010/0522 BAYER PLC UK Bonefos 800 mg tablets not available PL 00010/0522 BAYER PLC UK Bonefos 800 mg tablett, filmdrasjert. Bonefos 800 mg tablett, filmdrasjert. not available 95/2772 BAYER AB NO not available 95/2772 BAYER AB NO Bonefos 800 mg tabletta not available OGYI-T-2027/04 BAYER OY HU Bonefos 800 mg tabletta not available OGYI-T-2027/04 BAYER OY HU Bonefos 800 mg tabletti, kalvopäällysteinen Bonefos 800 mg tabletti, kalvopäällysteinen BONEFOS 800 mg, comprimés pelliculés BONEFOS 800 mg, comprimés pelliculés not available BAYER OY FI not available BAYER OY FI not available BE BAYER SA NV BE not available BE BAYER SA NV BE EMA/663554/2017 Page 5/12

6 BONEFOS 800 mg, comprimés pelliculés BONEFOS 800 mg, comprimés pelliculés BONEFOS 800 mg, filmomhulde tabletten BONEFOS 800 mg, filmomhulde tabletten Bonefos 800 mg, filmomhulde tabletten Bonefos 800 mg, filmomhulde tabletten Bonefos, 400 mg, kapsułki twarde Bonefos, 400 mg, kapsułki twarde Bonefos, filmovertrukne tabletter Bonefos, filmovertrukne tabletter Bonefos 400 mg Hartkapsel not available 0442/ BAYER SA NV LU not available 0442/ BAYER SA NV LU not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available RVG BAYER BV NL not available RVG BAYER BV NL not available R/0298 BAYER PHARMA AG PL not available R/0298 BAYER PHARMA AG PL not available BAYER AB DK not available BAYER AB DK not available BAYER VITAL GMBH DE EMA/663554/2017 Page 6/12

7 Bonefos 400 mg Hartkapsel BONEFOS 60 mg/ml Konzentrat zu Herstellung einer Infusionslösung BONEFOS 60 mg/ml Konzentrat zu Herstellung einer Infusionslösung BONEFOS 800 mg, Filmtabletten BONEFOS 800 mg, Filmtabletten BONEFOS 800 mg, Filmtabletten BONEFOS 800 mg, Filmtabletten Bonefos Filmtabletten 800 mg Bonefos Filmtabletten 800 mg CLASTEON 300 mg/10 ml not available BAYER VITAL GMBH DE not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available BE BAYER SA NV BE not available 0442/ BAYER SA NV LU not available 0442/ BAYER SA NV LU not available BAYER VITAL GMBH DE not available BAYER VITAL GMBH DE not available ABIOGEN PHARMA S.P.A. IT EMA/663554/2017 Page 7/12

8 CLASTEON 300 mg/10 ml CLASTEON 400 mg capsule rigide not available ABIOGEN PHARMA S.P.A. IT not available ABIOGEN PHARMA S.P.A. IT CLASTEON 400mg capsules not available S00700 BEACON PHARMACEUTICALS LIMITED CY CLASTEON 800mg filmcoated tablets UK/H/3419/001 PL 18157/0225 BEACON PHARMACEUTICALS LIMITED UK CLODEOSTEN 100 mg/3,3 ml soluzione iniettabile CLODRON 300 mg/10ml CLODRON 300 mg/10ml not available S.F. GROUP SRL IT not available FIDIA FARMACEUTICI S.P.A IT not available FIDIA FARMACEUTICI S.P.A IT Clodron A Pharma A PHARMA GMBH DE CLODRON 400 mg capsule rigide Clodron 400 mg HEXAL Filmtabletten not available FIDIA FARMACEUTICI S.P.A IT not available HEXAL AG DE Clodron A Pharma A PHARMA GMBH DE EMA/663554/2017 Page 8/12

9 Clodron 800 mg HEXAL Filmtabletten CLODRONATO ABC 100 mg/3,3 ml soluzione iniettabile CLODRONATO ABC 100 mg/3,3 ml soluzione iniettabile CLODRONATO ABC 300 mg/10 ml soluzione per infusione endovenosa CLODY 300 mg/10 ml not available HEXAL AG DE not available ABC FARMACEUTICI S.P.A. IT not available ABC FARMACEUTICI S.P.A. IT not available ABC FARMACEUTICI S.P.A. IT not available PROMEDICA S.R.L. IT DIFOSFONAL 300 mg/10 ml DIFOSFONAL 300 mg/10 ml DIFOSFONAL 400 mg capsule rigide not available SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A. not available SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A. not available SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A. IT IT IT Lodronat 520 not available 87/139/99-C RIEMSER PHARMA GMBH CZ EMA/663554/2017 Page 9/12

10 Lodronat 520 mg not available RIEMSER PHARMA GMBH AT Loron mg, film-coated tablets not available PL 42336/0002 RIEMSER PHARMA GMBH UK LYTOS 520 mg not available RIEMSER PHARMA GMBH FR MOTICLOD 100 mg/3,3 ml soluzione iniettabile MOTICLOD 100 mg/3,3 ml soluzione iniettabile MOTICLOD 300 mg/10 ml soluzione not available LAB. IT. BIOCHIM. FARM.CO LISAPHARMA S.P.A. not available LAB. IT. BIOCHIM. FARM.CO LISAPHARMA S.P.A. not available LAB. IT. BIOCHIM. FARM.CO LISAPHARMA S.P.A. IT IT IT Neogrand 800 mg filmtabletta Neogrand 800 mg filmtabletta Neogrand 800 mg filmtabletta Neogrand 800 mg filmtabletta NIKLOD 300 mg/10 ml not available OGYI-T-22548/01 ONCO-EUROPE LTD. HU not available OGYI-T-22548/02 ONCO-EUROPE LTD. HU not available OGYI-T-22548/03 ONCO-EUROPE LTD. HU not available OGYI-T-22548/04 ONCO-EUROPE LTD. HU not available I.B.N. SAVIO S.R.L. IT EMA/663554/2017 Page 10/12

11 NIKLOD 300 mg/10 ml not available I.B.N. SAVIO S.R.L. IT Ostac 520 not available RVG RIEMSER PHARMA GMBH NL Ostac 520 mg not available RIEMSER PHARMA GMBH DE Ostac 520 mg comprimidos revestidos Ostac 520 mg comprimidos revestidos OSTEONORM 100 mg/ 3,3 ml soluzione iniettabile OSTEONORM 100 mg/ 3,3 ml soluzione iniettabile OSTEONORM 100 mg/ 3,3 ml soluzione iniettabile OSTEONORM 100 mg/ 3,3 ml soluzione iniettabile not available RIEMSER PHARMA GMBH PT not available RIEMSER PHARMA GMBH PT not available I.B.N. SAVIO S.R.L. IT not available I.B.N. SAVIO S.R.L. IT not available I.B.N. SAVIO S.R.L. IT not available I.B.N. SAVIO S.R.L. IT SINDRONAT not available 87/0340/03-S ACTAVIS SRL SK SINDRONAT 300 MG/5 ML, CONCENTRAT PENTRU SOLUŢIE PERFUZABILĂ not available 2261/2016/01 ACTAVIS SRL RO EMA/663554/2017 Page 11/12

12 SINDRONAT, 400 mg, kapsulki twarde TRAXOVICAL 100 mg/ 3,3 ml soluzione iniettabile TRAXOVICAL 100 mg/ 3,3 ml soluzione iniettabile ACTAVIS GROUP PTC EHF. PL not available SAVIO PHARMA ITALIA SRL IT not available SAVIO PHARMA ITALIA SRL IT EMA/663554/2017 Page 12/12