List of nationally authorised medicinal products

Transcription

1 6 September 2018 EMA/615391/2018 Human Medicines Evaluation Division Active substance: tobramycin (nebuliser solution) (apart from centrally authorised product) 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 , NL/H/4274/ /11/00/32 NOVARTIS PHARMA N.V. LU solution pour inhalation par nébuliseur TOBI 300 mg/5 ml NL/H/4274/ /11/00/32 NOVARTIS PHARMA N.V. LU TOBI 300 mg/5 ml NL/H/4274/001 BE NOVARTIS PHARMA N.V. BE Tobi NL/H/4274/ NOVARTIS HEALTHCARE A/S DK Tobi 300 mg/5 ml solução para inalação por nebulização solución para inhalación por nebulizador Tobi 300 mg/5 ml sumutinliuos lösning för nebulisator TOBI 300 mg/5 ml Διάλυμα για εισπνοή με εκνεφωτή TOBI 300 mg/5 ml Διάλυμα για εισπνοή με εκνεφωτή TOBI 300 mg/5 ml Διάλυμα για εισπνοή με εκνεφωτή Tobi 300 mg/5 ml oldat porlasztásra NL/H/4274/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NL/H/4274/ NOVARTIS FARMACÉUTICA S.A. NL/H/4274/ NOVARTIS EUROPHARM LIMED NL/H/4274/ NOVARTIS FINLAND OY FI NL/H/4274/ NOVARTIS FINLAND OY FI NL/H/4274/ NOVARTIS (HELLAS) S.A.C.I. NL/H/4274/ NOVARTIS (HELLAS) S.A.C.I. NL/H/4274/ NOVARTIS (HELLAS) S.A.C.I. not available OGYI-T-8707/01 NOVARTIS NGÁRIA KFT. PHARMA PT ES GR GR GR EMA/615391/2018 Page 2/9

3 Tobi 300 mg/5 ml oldat porlasztásra Tobi 300 mg/5 ml oldat porlasztásra Tobi 300 mg/5 ml - inhalasjonsvæske til nebulisator, oppløsning TOBI 300 mg/5 ml nebuliser solution/ ТОБИ 300mg/5ml разтвор за пулверизиране verneveloplossing Tobi 300 mg/5 ml verneveloplossing, solution pour inhalation par nébuliseur soluţie pentru inhalare prin nebulizator soluţie pentru inhalare prin nebulizator soluţie pentru inhalare prin nebulizator not available OGYI-T-8707/02 NOVARTIS NGÁRIA KFT. PHARMA not available OGYI-T-8707/03 NOVARTIS NGÁRIA KFT. PHARMA NL/H/4274/ NOVARTIS PHARMA AT NL/H/4274/ NOVARTIS NORGE AS NO NL/H/4274/ NOVARTIS PHARMA DE not available NOVARTIS PHARMA BG NL/H/4274/001 BE NOVARTIS PHARMA N.V. BE NL/H/4274/001 RVG NOVARTIS PHARMA B.V. NL NL/H/4274/001 BE NOVARTIS PHARMA N.V. BE not available 8377/2015/01 NOVARTIS PHARMA RO not available 8377/2015/02 NOVARTIS PHARMA RO not available 8377/2015/03 NOVARTIS PHARMA RO EMA/615391/2018 Page 3/9

4 Tobi 300mg/5ml,solution pour inhalation par nébuliseur Tobi 300mg/5ml,solution pour inhalation par nébuliseur Tobi 300mg/5ml,solution pour inhalation par nébuliseur roztok pre rozprašovač TOBI 300 mg/5 ml, lösning för nebulisator TOBI 300 mg/5 ml Tobi διάλυμα για εισπνοή με εκνεφωτή 300mg/5ml BRAMOB 300 mg/4 ml BRAMOB 300 mg/4 ml BRAMOB 300 mg/4 ml NL/H/4274/ NOVARTIS PHARMA S.A.S. FR NL/H/4274/ NOVARTIS PHARMA S.A.S. FR NL/H/4274/ NOVARTIS PHARMA S.A.S. FR not available 15/0264/03-S NOVARTIS, S.R.O. SK NL/H/4274/001 PA 13/123/1 NOVARTIS PHARMACEUTICALS UK LIMED IE NL/H/4274/ NOVARTIS SVERIGE AB SE NL/H/4274/001 PL 00101/0935 NOVARTIS PHARMACEUTICALS UK LIMED UK not available 15/312/03-C NOVARTIS, S.R.O. CZ not available NOVARTIS PHARMACEUTICALS UK LIMED not available CHIESI FARMACEUTICI not available CHIESI FARMACEUTICI not available CHIESI FARMACEUTICI not available LT/1/11/2643/001 CHIESI PHARMACEUTICALS CY LT EMA/615391/2018 Page 4/9

5 BRAMOB 300 mg/4 ml šķīdums izsmidzināšanai BRAMOB 300 mg/4 ml otopina za atomizator Tobramycin "SUN", inhalationsvæske til nebulisator, opløsning Tobramycin SUN 300 mg Tobramycyna SUN, 300 mg/5 ml, roztwór do nebulizacji Tobramycine SUN 300 mg/5 ml verneveloplossing Tobramycin 300 mg/ 5 ml nebuliser solution Tobramicină SUN 300 mg soluţie pentru nebulizator Tobramicină SUN 300 mg soluţie pentru nebulizator not available LT/1/11/2643/002 CHIESI PHARMACEUTICALS not available LT/1/11/2643/003 CHIESI PHARMACEUTICALS not available CHIESI PHARMACEUTICALS not available UP/I /13-02/226 CHIESI PHARMACEUTICALS not available LT/1/11/2643/004 CHIESI PHARMACEUTICALS NL/H/3560/ SUN PHARMACEUTICAL NL/H/3560/ SUN PHARMACEUTICALS GERMANY NL/H/3560/ SUN PHARMACEUTICAL NL/H/3560/001 RVG SUN PHARMACEUTICAL NL/H/3560/001 PL 31750/0087 SUN PHARMACEUTICAL NL/H/3560/ /2017/01 SUN PHARMACEUTICAL NL/H/3560/ /2017/03 SUN PHARMACEUTICAL LT LT LV HR LT DK DE PL NL UK RO RO EMA/615391/2018 Page 5/9

6 Tobramicină SUN 300 mg soluţie pentru nebulizator Tobramicina SUN 300 mg/5 ml soluzione per Tobramicina SUN 300 mg/5 ml soluzione per Tobramicina SUN 300 mg/5 ml soluzione per Tobramicina SUN 300 mg/5 ml solución para inhalación por nebulizador Tobramicina Accord 300 mg/5 ml solución para inhalación por nebulizador Tobramicina Accord 300 mg/5 ml Solução para Inalação por Nebulização Tobramycin Teva 300 mg/5 ml Steri-Neb Tobramicina Teva 300 mg / 5 ml Soluzione per Tobramicina Teva 300 mg / 5 ml Soluzione per NL/H/3560/ /2017/02 SUN PHARMACEUTICAL NL/H/3560/ SUN PHARMACEUTICAL NL/H/3560/ SUN PHARMACEUTICAL NL/H/3560/ SUN PHARMACEUTICAL NL/H/3560/ SUN PHARMACEUTICAL PT/H/0504/ ACCORD HEALTHCARE S.L.U. PT/H/0504/ ACCORD HEALTHCARE LIMED UK/H/4346/ TEVA DE UK/H/4346/ TEVA ALIA S.R.L. UK/H/4346/ TEVA ALIA S.R.L. RO ES ES PT EMA/615391/2018 Page 6/9

7 Tobramicina Teva 300 mg / 5 ml Soluzione per Tobramycin 300 mg/5 ml Tobramycin Teva, inhalationsvæske til nebulisator, opløsning Tobramicina Teva, 300 mg/5 ml, Solução para Inalação por Nebulização Tobramicina Teva 300 mg/5 ml solución para inhalación por nebulizador Tymbrineb 300 mg/5 ml Tobramycine Steri-Neb 300 mg/5 ml, verneveloplossing 300 mg/5 ml 300 mg/5 ml šķīdums izsmidzināšanai 300 mg/5 ml nebuliseeritav lahus Тобрамицин Виа фарма 300 mg/5 ml разтвор за небулизатор UK/H/4346/ TEVA ALIA S.R.L. UK/H/4346/001 PL 00289/1437 TEVA UK LIMED UK UK/H/4346/ TEVA DENMARK A/S DK UK/H/4346/ TEVA PHARMA PRODUTOS FARMACÊUTICOS LDA UK/H/4346/ TEVA PHARMA S.L.U ES UK/H/4346/001 PA0749/117/001 TEVA PHARMA B.V. IE UK/H/4346/001 RVG TEVA NEDERLAND B.V. NL LT/H/0112/001 LT/1/16/3931/001 UAB VIA PHARMA LT LT/H/0112/ UAB VIA PHARMA LV LT/H/0112/ UAB VIA PHARMA EE LT/H/0112/ UAB VIA PHARMA BG PT EMA/615391/2018 Page 7/9

8 300 mg/ 5 ml oldat porlasztasra, 300 mg/5 ml, roztwór do nebulizacji 300 mg/5 ml soluţie pentru inhalare prin nebulizator BRAMOB, verneveloplossing 300 mg/4 ml BRAMOB 300 mg/4 ml TOBRINEB 300 mg/4 ml TOBRINEB 300 mg/4 ml TOBRINEB 300 mg/4 ml TOBRINEB 300 mg/4 ml BRAMOB 300 mg/4 ml Solución para inhalación por nebulizador Bramitob 300mg/4ml Bramitob 300mg/4ml LT/H/0112/001 OGYI-T-23038/01 UAB VIA PHARMA LT/H/0112/ UAB VIA PHARMA PL LT/H/0112/ /2016/01 UAB VIA PHARMA RO /H/0132/001 RVG CHIESI PHARMACEUTICALS B.V. /H/0132/ CHIESI DE /H/0132/ PROMEDICA S.R.L. /H/0132/ PROMEDICA S.R.L. /H/0132/ PROMEDICA S.R.L. /H/0132/ PROMEDICA S.R.L. /H/0132/ CHIESI ESPAÑA, S.A. ES /H/0132/001 PA 743/17/1 CHIESI LIMED IE /H/0132/001 PL 8829/0155 CHIESI LIMED UK NL EMA/615391/2018 Page 8/9

9 /H/0132/ CHIESI PHARMACEUTICALS BRAMOB /H/0132/001 15/214/07-C CHIESI PHARMACEUTICALS Bramitob 300 mg /4 ml oldat porlasztásra Bramitob 300 mg /4 ml oldat porlasztásra Bramitob 300 mg /4 ml oldat porlasztásra Bramitob 300 mg /4 ml oldat porlasztásra roztok na rozprašovanie BRAMOB 300 mg/ 4 ml Διάλυμα για εισπνοή με εκνεφωτή σε περιέκτη μίας δόσης Solução para inalação por nebulização Bramitob, 300 mg/4 ml, roztwór do nebulizacji /H/0132/001 OGYI-T /04 CHIESI PHARMACEUTICALS /H/0132/001 OGYI-T /01 CHIESI PHARMACEUTICALS /H/0132/001 OGYI-T /02 CHIESI PHARMACEUTICALS /H/0132/001 OGYI-T /03 CHIESI PHARMACEUTICALS /H/0132/001 15/0534/06-S CHIESI PHARMACEUTICALS /H/0132/ / CHIESI HELLAS A.E.B.E. GR /H/0132/ CHIESI FARMACEUTICI /H/0132/ CHIESI FARMACEUTICI AT CZ SK PT PL EMA/615391/2018 Page 9/9