List of nationally authorised medicinal products
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1 12 January 2017 EMA/28753/2017 Human Medicines Evaluation Division Active substance: moxifloxacin (topical ophthalmic use) 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 National Number Floxamic, 5 mg/ml, DK/H/2219/ ZAKLADY FARMACEUTYCZNE PL "POLPHARMA" SPOLKA AKCYJNA Floxitrat Ofta DE/H/3817/ SANDOZ GMBH PL KANAVIG 5 mg/ml Augentropfen DE/H/1588/ ALCON NV LU KANAVIG 5 mg/ml collyre en solution DE/H/1588/ ALCON NV LU Lifodrox 5 mg/ml acu pilieni, šķīdums DK/H/2221/ PHARMASWISS ČESKÁ LV LIFODROX 5 mg/ml akių lašai (tirpalas) DK/H/2221/001 LT/1/14/3520/001 PHARMASWISS ČESKÁ LT Lifodrox 5 mg/ml silmatilgad, lahus DK/H/2221/ PHARMASWISS ČESKÁ EE Moksacin 5 mg/ml kapi za oko, otopina not available UP/I /10-01/535 BONIFARM D.O.O. HR Monafox, 5 mg/ml, DK/H/2220/ ADAMED PL Monafox, øjendråber, opløsning DK/H/2220/ ADAMED DK EMA/28753/2017 Page 2/7
3 MOXIFLOXACIN ALCON 5 mg/ml Augentropfen National Number DE/H/1588/ ALCON PHARMA GMBH DE Moxifloxacin HEXAL 5 mg/ml Augentropfen DE/H/3817/ HEXAL AG DE Moxifloxacin Sandoz DE/H/3817/001 OGYI-T-22540/01 SANDOZ HUNGÁRIA KFT HU 5mg/ml oldatos szemcsepp MOXIFLOXACINA DK/H/2219/ /2014/01 PHARMATHEN S.A. RO PHARMATHEN 5 MG/ML PICĂTURI OFTALMICE, SOLUŢIE Moxifloxacina Sandoz DE/H/3817/ SANDOZ S.P.A. IT Moxifloxacino Kern Pharma 5 mg/ml colirio en solución Moxifloxacino Kern Pharma 5 mg/ml colirio en solución MOXIFLOXACINO PHARMATHEN 5 MG/ML COLIRIO EN SOLUCIÓN MOXIFLOXACINO SANDOZ 5 MG/ML COLIRIO EN SOLUCION not available KERN PHARMA, S.L. ES not available KERN PHARMA, S.L. ES DK/H/2219/ PHARMATHEN S.A. ES DE/H/3817/ SANDOZ FARMACÉUTICA, ES S.A. EMA/28753/2017 Page 3/7
4 MOXIVIG 0.5%w/v eye drops, solution National Number DE/H/1588/001 PA 290/79/1 ALCON LABORATORIES (UK) LTD IE MOXIVIG 0.5%w/v eye drops, solution DE/H/1588/001 PL 00649/0378 ALCON LABORATORIES (UK) LTD UK Tamvelier 5mg/ml οφθαλμικές σταγόνες, διάλυμα VAMOCIN 5MG/ML, ØJENDRÅBER, OPLØSNING acu pilieni, šķīdums DK/H/2219/ / PHARMATHEN HELLAS S.A. GR DK/H/2219/ PHARMATHEN S.A. DK DE/H/1588/ SA ALCON-COUVREUR NV LV akių lašai (tirpalas) DE/H/1588/001 LT/1/09/1655/001 SA ALCON-COUVREUR NV LT Augentropfen DE/H/1588/ ALCON PHARMA GMBH DE colirio en solución DE/H/1588/ ALCON CUSI, S.A ES colírio, solução DE/H/1588/ ALCON PORTUGAL - PRODUTOS E EQUIPAMENTOS OFTALMOLÓGICOS, LDA. PT EMA/28753/2017 Page 4/7
5 collirio, soluzione National Number DE/H/1588/ ALCON ITALIA S.P.A. IT eye drops, solution DE/H/1588/ /01301 SA ALCON-COUVREUR NV MT kapljice za oko, raztopina DE/H/1588/001 H/09/1916/001 SA ALCON-COUVREUR NV SI očná roztoková instilácia DE/H/1588/001 64/0450/09-S SA ALCON-COUVREUR NV SK OČNÍ KAPKY oční kapky, roztok DE/H/1588/001 64/545/09-C ALCON PHARMACEUTICALS, CZECH REPUBLIC SRO CZ Vigamox 5 mg/ml ögondroppar, lösning DE/H/1588/ ALCON NORDIC A/S SE Vigamox 5 mg/ml oldatos szemcsepp DE/H/1588/001 OGYI-T-22430/01 ALCON HUNGARIAN LTD. HU oogdruppels, oplossing DE/H/1588/001 RVG ALCON NEDERLAND BV NL picături oftalmice, soluţie DE/H/1588/ /2009/01 ALCON PHARMA GMBH RO EMA/28753/2017 Page 5/7
6 οφθαλμικές σταγόνες, διάλυμα οφθαλμικές σταγόνες, διάλυμα Vigamox 5 mg/ml augndropar, lausn. National Number DE/H/1588/ ALCON LABORATORIES HELLAS S.A. DE/H/1588/ / ALCON LABORATORIES HELLAS S.A. DE/H/1588/001/DC IS/1/08/066/01 ALCON NORDIC A/S IS CY GR silmätipat, liuos DE/H/1588/ ALCON NORDIC A/S FI VIGAMOX, 5 mg/ml silmatilgad, lahus DE/H/1588/ SA ALCON-COUVREUR NV EE VIGAMOX, 5 mg/ml, DE/H/1588/ ALCON POLSKA SP. Z.O.O PL Vigamox, øjendråber, opløsning DE/H/1588/ ALCON NORDIC A/S DK Xiflodrop 5 mg/ml oldatos szemcsepp DK/H/2221/001 OGYI-T-22624/01 PHARMASWISS ČESKÁ HU XIFLODROP 5mg/ml očná roztoková instilácia DK/H/2221/001 64/0100/14-S PHARMASWISS ČESKÁ SK EMA/28753/2017 Page 6/7
7 Xiflodrop, 5 mg/ml, National Number DK/H/2221/ PHARMASWISS ČESKÁ PL Xiflodrop, øjendråber, opløsning DK/H/2221/ PHARMASWISS ČESKÁ DK ВИГАМОКС 5 mg/ml, капки за очи, разтвор DE/H/1588/001 II-4951 ALCON PHARMA GMBH BG КСИФЛОДРОП 5 mg/ml капки за очи, разтвор DK/H/2221/ PHARMASWISS ČESKÁ BG Моксифлоксан 5 mg/ml, капки за очи, разтвор not available ANTIBIOTIC-RAZGRAD AD BG EMA/28753/2017 Page 7/7
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