List of nationally authorised medicinal products

Transcription

1 30 November 2017 EMA/817337/2017 Human Medicines Evaluation Division Active substance: Itraconazole 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 Member where Sporanox 10 mg/ml Lösung UK/H/0158/001 BE JANSSEN-CILAG NV BE zum Einnehmen Sporanox 10 mg/ml oral UK/H/0158/ JANSSEN-CILAG OY FI lösning Sporanox 10 mg/ml Lösung UK/H/0158/ JANSSEN-CILAG NV LU zum Einnehmen SPORANOX 10 mg/ml Oral UK/H/0158/001 PL 00242/0307 JANSSEN-CILAG LIMITED UK Solution. SPORANOX 10 mg/ml solution UK/H/0158/ JANSSEN-CILAG NV LU buvable Sporanox 10 mg/ml Lösung UK/H/0158/ JANSSEN-CILAG PHARMA AT zum Einnehmen GMBH Sporanox 10 mg/ml oral UK/H/0158/ JANSSEN-CILAG AB SE lösning SPORANOX 10 mg/ml UK/H/0158/ JANSSEN-CILAG OY FI oraaliliuos Sempera Liquid 10 mg/ml, UK/H/0158/ JANSSEN-CILAG GMBH DE Lösung zum Einnehmen SPORANOX 10 mg/ml Oral UK/H/0158/001 PA 0748/009/001 JANSSEN-CILAG LIMITED IE Solution. SPORANOX 10 mg/ml solution UK/H/0158/001 BE JANSSEN-CILAG NV BE buvable SPORANOX 10 mg/ml, drank. UK/H/0158/001 BE JANSSEN-CILAG NV BE Trisporal O.S.-drank 10 mg/ml, drank. SPORANOX 10 mg/ml soluzione orale UK/H/0158/001 RVG JANSSEN-CILAG BV NL UK/H/0158/ /M JANSSEN-CILAG SPA IT EMA/817337/2017 Page 2/8

3 Member where SPORANOX 10 mg/ml Solução UK/H/0158/ JANSSEN FARMACÊUTICA PT Oral Sporanox 100 mg Hartkapseln not available BE JANSSEN-CILAG NV BE Sporanox 100 mg kapsel, hård not available JANSSEN-CILAG OY FI SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR Sporanox 100 mg Hartkapseln not available JANSSEN-CILAG NV LU SPORANOX 100 mg capsule not available JANSSEN-CILAG SPA IT rigide SIROS Kapseln, 100 mg not available JANSSEN-CILAG GMBH DE Hartkapseln SPORANOX 100 mg kapsuly not available 26/0194/90-C/S JOHNSON & JOHNSON, S.R.O SK SPORAL 100mg Capsules. not available 018/02401 JANSSEN-CILAG INTERNATIONAL NV MT EMA/817337/2017 Page 3/8

4 Member where SPORAL 100mg Capsules. not available 018/02401 JANSSEN-CILAG MT INTERNATIONAL NV SEMPERA 7 Kapseln, 100 mg not available JANSSEN-CILAG GMBH DE Hartkapseln Orungal 100 mg kemény not available OGYI-T-2172/03 JANSSEN-CILAG KFT. HU kapszula Orungal 100 mg kemény not available OGYI-T-2172/02 JANSSEN-CILAG KFT. HU kapszula Orungal 100 mg kemény not available OGYI-T-2172/01 JANSSEN-CILAG KFT. HU kapszula Orungal 100 mg capsule not available 4909/2004/02 JANSSEN PHARMACEUTICA NV RO SPORAL 100 mg Capsules not available JANSSEN-CILAG CY INTERNATIONAL NV Trisporal 100 mg capsules, not available RVG JANSSEN-CILAG BV NL hard. SPORANOX 100 mg, gélules not available JANSSEN-CILAG NV LU Sporanox, kapsler not available JANSSEN-CILAG A/S DK SPORANOX 10 mg/ml, solution not available JANSSEN-CILAG FR buvable Sporanox 100 mg Capsules not available PL 00242/0142 JANSSEN-CILAG LIMITED UK SPORANOX 10 mg/ml perorální roztok SPORANOX 100 mg capsules, hard not available 26/1097/97-C JANSSEN-CILAG S.R.O CZ not available BE JANSSEN-CILAG NV BE EMA/817337/2017 Page 4/8

5 Member where SPORANOX 100 mg, gélules not available BE JANSSEN-CILAG NV BE ORUNGAL, 100 mg, kapsułki not available R/0043 JANSSEN-CILAG PL INTERNATIONAL NV Sporanox 100 mg kapsel, hard not available 8158 JANSSEN-CILAG A/S NO Trisporal IV 10 mg/ml not available RVG JANSSEN-CILAG BV NL concentraat en oplosmiddel voor oplossing voor infusie Sporanox DERM 100 mg not available JANSSEN-CILAG PHARMA AT Kapseln GMBH SPORANOX 10 mg/ml πόσιμο not available 39720/10/ JANSSEN-CILAG GR διάλυμα PHARMACEUTICAL C.I. Sporanox-Pulse not available PL 00242/0334 JANSSEN-CILAG LIMITED UK Sporanox 100 mg Kapseln not available JANSSEN-CILAG PHARMA AT GMBH SPORANOX 100 mg, gélule not available JANSSEN-CILAG FR SEMPERA Kapseln, 100 mg not available JANSSEN-CILAG GMBH DE Hartkapseln Sporanox 100 mg hylki, hörð. not available JANSSEN-CILAG AB IS Sporanox 100 mg hårda not available JANSSEN-CILAG AB SE kapslar SPORANOX 100mg Capsules not available PA 0748/009/002 JANSSEN-CILAG LIMITED IE EMA/817337/2017 Page 5/8

6 Member where SPORANOX 10 mg/ml not available 5363-I-32/08 JOHNSON & JOHNSON SI peroralna raztopina PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. SPORANOX 100 mg trde not available 5363-I-433/10 JOHNSON & JOHNSON SI kapsule PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. SPORANOX 100 mg trde not available 5363-I-365/12 JOHNSON & JOHNSON SI kapsule PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. SPORANOX 100 MG καψάκια not available 39717/10/ JANSSEN-CILAG GR σκληρά PHARMACEUTICAL C.I. SPORANOX 100 mg trde not available 5363-I-434/10 JOHNSON & JOHNSON SI kapsule PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. Sporanox 100 mg cápsulas not available JANSSEN FARMACÊUTICA PT Sporanox 100 mg cápsulas not available JANSSEN FARMACÊUTICA PT Sporanox 100 mg cápsulas not available JANSSEN FARMACÊUTICA PT Sporanox 100 mg cápsulas not available JANSSEN FARMACÊUTICA PT Sporanox 100 mg kapseli, kova not available JANSSEN-CILAG OY FI EMA/817337/2017 Page 6/8

7 Member where SPORANOX 100 mg cápsulas not available JANSSEN-CILAG ES Orungal 100 mg capsule not available 4909/2004/03 JANSSEN PHARMACEUTICA NV RO Orungal 100 mg capsule not available 4909/2004/01 JANSSEN PHARMACEUTICA NV RO Micogal 100 mg capsule not available 7080/2014/01 S.C. ROMPHARM COMPANY RO S.R.L. SPORANOX IV 10 mg/ml UK/H/0158/ /M JANSSEN-CILAG SPA IT concentrato e solvente, soluzione per infusione Sempera 10 mg/ml Konzentrat UK/H/0158/ JANSSEN-CILAG GMBH DE und Lösungsmittel zur Herstellung einer Infusionslösung Sporanox IV 10 mg/ml UK/H/0158/002 PL 00242/0344 JANSSEN-CILAG LIMITED UK concentrate and solvent for solution for infusion. SPORANOX IV 10 mg/ml UK/H/0158/002 PA 748/9/4 JANSSEN-CILAG LIMITED IE concentrate and solvent for solution for infusion. SPORANOX I.V. 10 mg/ml UK/H/0158/ JANSSEN-CILAG GR πυκνό διάλυμα και διαλύτης για παρασκευή διαλύματος προς έγχυση PHARMACEUTICAL C.I. SPORANOX IV 10 mg/ml, concentrado e solvente para solução para perfusão. UK/H/0158/ JANSSEN FARMACÊUTICA PT EMA/817337/2017 Page 7/8

8 Member where ITRAGERM 50 mg cápsulas UK/H/4345/ MAYNE PHARMA UK LIMITED ES duras ITRAISDIN 50 mg Hartkapseln UK/H/4345/ ISDIN GMBH DE Mytra 50 mg Hartkapseln UK/H/4345/ A-MED GMBH AT LOZANOC 50 mg hard capsules UK/H/4345/01/DC PL 37190/0001 MAYNE PHARMA UK LIMITED UK CANADIOL 10 mg/ml solución not available LABORATORIOS DR. ESTEVE ES oral CANADIOL 100 mg cápsulas not available LABORATORIOS DR. ESTEVE ES CANADIOL 10 mg/ml solución not available LABORATORIOS DR. ESTEVE ES oral CANADIOL 100 mg cápsulas not available LABORATORIOS DR. ESTEVE ES CANADIOL 10 mg/ml solución not available LABORATORIOS DR. ESTEVE ES oral CANADIOL 100 mg cápsulas not available LABORATORIOS DR. ESTEVE ES TRIASPORIN 100 mg capsule not available ITALFARMACO S.P.A IT rigide TRIASPORIN 10 mg/ml not available ITALFARMACO S.P.A IT soluzione orale Hongoseril 100 mg cápsulas not available ISDIN, ES EMA/817337/2017 Page 8/8