Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

29 May 2019 EMA/397212/2019 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: levofloxacin (except for the centrally authorised product)

Procedure no.: PSUSA/00001854/201810

List of nationally authorised medicinal products EMA/397212/2019 Page 2/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levomer, 5 mg/ml, krople do oczu, roztwór PT/H/1495/001/DC 23616 ADAMED PL

LEXAVON 5 mg/ml οφθαλμικές σταγόνες, διάλυμα PT/H/0821/001 82071/28-09-2017 RAFARM SA. GR

Lexavon eye drops solution/Rafarm 5mg/mL PT/H/821/01/DC 021948 RAFARM SA. CY

Levofloxacina Rafarm 5 mg/ml colírio, solução PT/H/0821/001 5601257 RAFARM SA. PT

Oftaquix 5 mg/ml -silmätipat MRP UK/H/464/001 16992 SANTEN OY FI

Oftaquix 5 mg/ml ögondroppar MRP UK/H/464/001 16992 SANTEN OY FI

Oftaquix 5 mg/ml ögondroppar, lösning FI/H/0989/001 17994 SANTEN OY SE

Oftaquix, øjendråber, opløsning UK/H/0464/001 33160 SANTEN OY DK

Oftaquix 5 mg/ml oční kapky, roztok UK/H/0464/001 64/175/05-C SANTEN OY CZ

List of nationally authorised medicinal products EMA/397212/2019 Page 3/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Oftaquix 5 mg/ml augndropar, lausn FI/H/0989/001 IS/1/02/003/01 SANTEN OY IS

Oftaquix 5 mg/ml silmatilgad, lahus UK/H/0464/001 472305 SANTEN OY EE

Oftaquix 5 mg/ml Augentropfen, Lösung UK/H/0464/001 53538.00.00 SANTEN OY DE

Oftaquix 5 mg/ml oldatos szemcsepp MRP UK/H/464/001 OGYI-T-10257/01 SANTEN OY HU

Oftaquix 5 mg/ml collirio, soluzione FI/H/0989/001 035728017 SANTEN OY IT

Oftaquix 5 mg/ml acu pilieni, šķīdums FI/H/0989/001 05-0196 SANTEN OY LV

OFTAQUIX 5 mg/ml akių lašai (tirpalas) FI/H/0989/001 LT/1/05/0325/001 SANTEN OY LT

Oftaquix 5 mg/ml colírio MRP FI/H/989/01 4041786 SANTEN OY PT

Oftaquix 5 mg/ml očná roztoková instilácia FI/H/0989/001 64/0180/05-S SANTEN OY SK

List of nationally authorised medicinal products EMA/397212/2019 Page 4/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Oftaquix 5 mg/ml eye drops FI/H/0989/001 PL 16058/0006 SANTEN OY UK

Oftaquix 5 mg/ml Augentropfen FI/H/0989/001

NO.AMM 2002050011, NO. NAT. 0318046 SANTEN OY LU

Oftaquix 5 mg/ml Augentropfen MRP UK/H/464/001 1-24655 SANTEN OY AT

OFTAQUIX 5 mg/ml picături oftalmice, soluţie MRP FI/H/989/01 4609/2012/01 SANTEN OY RO

FLOXISTILL 5 mg/ml collirio soluzione PT/H/1360/001 044071013 BRUSCHETTINI S.R.L IT

Levofloxacina Bruschettini 5 mg/ml colírio, solução PT/H/1360/001/DC 5666540 BRUSCHETTINI S.R.L PT

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 19282 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 19282 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 19282 SANOFI-AVENTIS CYPRUS LTD CY

List of nationally authorised medicinal products EMA/397212/2019 Page 5/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 19282 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 19282 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC 5 MG/ML, SOLUTION POUR PERFUSION DE/H/5119/003 34009 561 899 2 2 SANOFI-AVENTIS FRANCE FR

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

TAVANIC 500 MG, COMPRIME DE/H/5119/002 34009 349 655 6 2 SANOFI-AVENTIS FRANCE FR

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

List of nationally authorised medicinal products EMA/397212/2019 Page 6/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

TAVANIC 500 MG FILMDRAGERAD TABLETT DE/H/5119/002 14136 SANOFI AB SE

TAVANIC DE/H/5119/003 8766 SANOFI-AVENTIS DEUTSCHLAND GMBH PL

TAVANIC 5 MG/ML, SOLUTION POUR PERFUSION DE/H/5119/003 34009 561 898 6 1 SANOFI-AVENTIS FRANCE FR

TAVANIC 5 MG/ML, SOLUTION POUR PERFUSION DE/H/5119/003 34009561 901 7 1 SANOFI-AVENTIS FRANCE FR

TAVANIC 5 MG/ML, SOLUTION POUR PERFUSION DE/H/5119/003 34009 561 900 0 3 SANOFI-AVENTIS FRANCE FR

TAVANIC 500 MG, COMPRIME DE/H/5119/002 34009 349 656 2 3 SANOFI-AVENTIS FRANCE FR

TAVANIC 500 MG, COMPRIME DE/H/5119/002 34009 561 904 6 1 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/397212/2019 Page 7/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 500 MG, COMPRIME DE/H/5119/002 34009 348 996 4 5 SANOFI-AVENTIS FRANCE FR

TAVANIC 500 MG, COMPRIME DE/H/5119/002 34009 574 907 9 9 SANOFI-AVENTIS FRANCE FR

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

List of nationally authorised medicinal products EMA/397212/2019 Page 8/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 500 mg plėvele dengtos tabletės DE/H/5119/002 LT R 02/7797/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

Tavanic 250 mg plėvele dengtos tabletės DE/H/5119/001 LT R 02/7796/6 UAB SANOFI-AVENTIS LIETUVA LT

TAVANIC 5 MG/ML RAZTOPINA ZA INFUNDIRANJE DE/H/5119/003 H/00/01496/015 SANOFI-AVENTIS D.O.O. SI

TAVANIC 500 MG FILMSKO OBLOZENE TABLETE DE/H/5119/002 H/00/01496/008 SANOFI-AVENTIS D.O.O. SI

TAVANIC 500 MG FILMTABLETTA DE/H/5119/002 OGYI-T-6837/07 SANOFI-AVENTIS ZRT HU

List of nationally authorised medicinal products EMA/397212/2019 Page 9/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 500 MG FILMTABLETTA DE/H/5119/002 OGYI-T-6837/14 SANOFI-AVENTIS ZRT HU

TAVANIC 500 MG FILMTABLETTA DE/H/5119/002 OGYI-T-6837/06 SANOFI-AVENTIS ZRT HU

TAVANIC DE/H/5119/002 6160/17-02-99 SANOFI-AVENTIS AEBE GR

TAVANIC DE/H/5119/003 6161/17-02-99 SANOFI-AVENTIS AEBE GR

TAVANIC DE/H/5119/002 6160/17-02-99 SANOFI-AVENTIS AEBE GR

TAVANIC DE/H/5119/002 6160/17-02-99 SANOFI-AVENTIS AEBE GR

TAVANIC DE/H/5119/002 6160/17-02-99 SANOFI-AVENTIS AEBE GR

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Tavanic, 250 mg õhukese polümeerikattega tabletid DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE

List of nationally authorised medicinal products EMA/397212/2019 Page 10/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC, 5 MG/ML INFUSIOONILAHUS DE/H/5119/003 424003 SANOFI-AVENTIS ESTONIA OÜ EE

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG

Таваник 500mg филмирани таблетки DE/H/5119/002 20020443 SANOFI BULGARIA EOOD BG TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE

List of nationally authorised medicinal products EMA/397212/2019 Page 11/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE

List of nationally authorised medicinal products EMA/397212/2019 Page 12/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 250 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/001 424203 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE TAVANIC, 500 MG OHUKESE POLUMEERIKATTEGA TABLETID DE/H/5119/002 424103 SANOFI-AVENTIS ESTONIA OÜ EE

TAVANIC, 5 MG/ML INFUSIOONILAHUS DE/H/5119/003 424003 SANOFI-AVENTIS ESTONIA OÜ EE

TAVANIC, 5 MG/ML INFUSIOONILAHUS DE/H/5119/003 424003 SANOFI-AVENTIS ESTONIA OÜ EE

TAVANIC, 5 MG/ML INFUSIOONILAHUS DE/H/5119/003 424003 SANOFI-AVENTIS ESTONIA OÜ EE

TAVANIC, 5 MG/ML INFUSIOONILAHUS DE/H/5119/003 424003 SANOFI-AVENTIS ESTONIA OÜ EE

List of nationally authorised medicinal products EMA/397212/2019 Page 13/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC DE/H/5119/002 19283 SANOFI-AVENTIS CYPRUS LTD CY

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

List of nationally authorised medicinal products EMA/397212/2019 Page 14/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 250 MG FILMDRAGERAD TABLETT DE/H/5119/001 14135 SANOFI AB SE

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 14134 SANOFI AB SE

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 14134 SANOFI AB SE

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 14134 SANOFI AB SE

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 14134 SANOFI AB SE

List of nationally authorised medicinal products EMA/397212/2019 Page 15/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 5 MG/ML SOLUTION FOR INFUSION DE/H/5119/003 14134 SANOFI AB SE

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC 500 MG FILM-COATED TABLETS DE/H/5119/002 MA 082/03502 SANOFI MALTA LTD MT

TAVANIC I.V. DE/H/5119/003 42/176/01-C SANOFI-AVENTIS SRO CZ

List of nationally authorised medicinal products EMA/397212/2019 Page 16/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC I.V. DE/H/5119/003 42/176/01-C SANOFI-AVENTIS SRO CZ

TAVANIC I.V. DE/H/5119/003 42/176/01-C SANOFI-AVENTIS SRO CZ

TAVANIC I.V. DE/H/5119/003 42/176/01-C SANOFI-AVENTIS SRO CZ

TAVANIC I.V. DE/H/5119/003 42/176/01-C SANOFI-AVENTIS SRO CZ

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 BE192875 SANOFI BELGIUM BE

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 BE230237 SANOFI BELGIUM BE

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 BE192875 SANOFI BELGIUM BE

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 BE192875 SANOFI BELGIUM BE

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 BE230237 SANOFI BELGIUM BE

List of nationally authorised medicinal products EMA/397212/2019 Page 17/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 3088382

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 2628584

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 3088481

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 2628881

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 2628485

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 3088283

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

List of nationally authorised medicinal products EMA/397212/2019 Page 18/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

TAVANIC 500 mg comprimidos revestidos por película DE/H/5119/002 2628683

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

Tavanic Infusionsflasche DE/H/5119/003 1-22321 SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

TAVANIC 5 mg/ml solução para perfusão DE/H/5119/003 3088580

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic Infusionsflasche DE/H/5119/003 1-22321 SANOFI-AVENTIS GMBH OSTERREICH AT

List of nationally authorised medicinal products EMA/397212/2019 Page 19/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic Infusionsflasche DE/H/5119/003 1-22321 SANOFI-AVENTIS GMBH OSTERREICH AT

TAVANIC 5 mg/ml solução para perfusão DE/H/5119/003 2628980

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

Tavanic Infusionsflasche DE/H/5119/003 1-22321 SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

List of nationally authorised medicinal products EMA/397212/2019 Page 20/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

TAVANIC 5 mg/ml solução para perfusão DE/H/5119/003 3088788

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic® 500 mg Filmtabletten DE/H/5119/002 1-22320

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 5 mg/ml solution for infusion DE/H/5119/003 PA 540/77/001

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic Infusionsflasche DE/H/5119/003 1-22321 SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

TAVANIC 5 mg/ml solução para perfusão DE/H/5119/003 3088689

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

List of nationally authorised medicinal products EMA/397212/2019 Page 21/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 500 MG COMPRESSE RIVESTITE CON FILM DE/H/5119/002 033634054 SANOFI S.P.A IT

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 5 mg/ml oplossing voor infusie DE/H/5119/003 BE192875 SANOFI BELGIUM BE

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

Tavanic 500 mg kalvopäällysteiset tabletit DE/H/5119/002 12947 SANOFI OY FI

Tavanic 250 mg comprimé pelliculé DE/H/5119/001 0247087 SANOFI BELGIUM LU

Tavanic 5 mg/ml oplossing voor infusie DE/H/5119/003 BE192875 SANOFI BELGIUM BE

List of nationally authorised medicinal products EMA/397212/2019 Page 22/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 5 mg/ml solución para perfusión DE/H/5119/003 62066 SANOFI-AVENTIS, S.A. ES

Tavanic 5 mg/ml solution for infusion DE/H/5119/003 PA 540/77/001

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 250 mg comprimé pelliculé DE/H/5119/001 0247056 SANOFI BELGIUM LU

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

TAVANIC 500 MG COMPRESSE RIVESTITE CON FILM DE/H/5119/002 033634041 SANOFI S.P.A IT

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 500 mg film-coated tablets DE/H/5119/002 PA 540/77/3

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

List of nationally authorised medicinal products EMA/397212/2019 Page 23/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic® 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 250 mg Filmtabletten DE/H/5119/001 1-22319

SANOFI-AVENTIS GMBH OSTERREICH AT

Tavanic 250 mg comprimé pelliculé DE/H/5119/001 0247073 SANOFI BELGIUM LU

Tavanic 250 mg comprimé pelliculé DE/H/5119/001 0247915 SANOFI BELGIUM LU

Tavanic IV, oplossing voor infusie 5 mg/ml DE/H/5119/003 RVG 21810

SANOFI-AVENTIS NETHERLANDS B.V. NL

TAVANIC 500 MG COMPRESSE RIVESTITE CON FILM DE/H/5119/002 033634039 SANOFI S.P.A IT

TAVANIC 5 mg/ml solução para perfusão DE/H/5119/003 2978682

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic IV, oplossing voor infusie 5 mg/ml DE/H/5119/003 RVG 21810

SANOFI-AVENTIS NETHERLANDS B.V. NL

List of nationally authorised medicinal products EMA/397212/2019 Page 24/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

Tavanic 5 mg/ml oplossing voor infusie DE/H/5119/003 BE230237 SANOFI BELGIUM BE

Tavanic 250 mg film-coated tablets DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

List of nationally authorised medicinal products EMA/397212/2019 Page 25/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

Tavanic 250 mg kalvopäällysteiset tabletit DE/H/5119/001 12946 SANOFI OY FI

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 500 mg filmomhulde tabletten DE/H/5119/002 BE192884 SANOFI BELGIUM BE

TAVANIC 250 MG FILM-COATED TABLETS DE/H/5119/001 PA 540/77/2

SANOFI-AVENTIS IRELAND LTD. T/A SANOFI IE

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 0247141 SANOFI BELGIUM LU

List of nationally authorised medicinal products EMA/397212/2019 Page 26/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 5 mg/ml Infusionslösung DE/H/5119/003 41384.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 5 mg/ml Infusionslösung DE/H/5119/003 41384.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 500 mg comprimé pelliculé DE/H/5119/002 0247137 SANOFI BELGIUM LU

Tavanic 5 mg/ml Infusionslösung DE/H/5119/003 41384.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 500 mg comprimé pelliculé DE/H/5119/002 0247106 SANOFI BELGIUM LU

Tavanic 5 mg/ml solution pour perfusion DE/H/5119/003 0305701 SANOFI BELGIUM LU

Tavanic 5 mg/ml Infusionslösung DE/H/5119/003 41384.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 500 mg comprimé pelliculé DE/H/5119/002 0247091 SANOFI BELGIUM LU

Tavanic 500 mg comprimé pelliculé DE/H/5119/002 0247123 SANOFI BELGIUM LU

List of nationally authorised medicinal products EMA/397212/2019 Page 27/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic® 250 mg Filmtabletten DE/H/5119/001 41382.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic® 250 mg Filmtabletten DE/H/5119/001 41382.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic® 250 mg Filmtabletten DE/H/5119/001 41382.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic® 250 mg Filmtabletten DE/H/5119/001 41382.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic® 250 mg Filmtabletten DE/H/5119/001 41382.00.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 2628386

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 2627982

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 5 MG/ML SOLUZIONE PER INFUSIONE DE/H/5119/003 033634080 SANOFI S.P.A IT

TAVANIC 5 MG/ML SOLUZIONE PER INFUSIONE DE/H/5119/003 033634066 SANOFI S.P.A IT

List of nationally authorised medicinal products EMA/397212/2019 Page 28/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 250 MG DE/H/5119/001 033634015 SANOFI S.P.A IT

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

Tavanic® 500 mg Filmtabletten DE/H/5119/002 41382.01.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

Tavanic 5 mg/ml oplossing voor infusie DE/H/5119/003 BE192875 SANOFI BELGIUM BE

TAVANIC 5 MG/ML INFUUSIONESTE, LIUOS DE/H/5119/003 12948 SANOFI OY FI

TAVANIC 5 MG/ML INFUUSIONESTE, LIUOS DE/H/5119/003 12948 SANOFI OY FI

TAVANIC 5 MG/ML INFUUSIONESTE, LIUOS DE/H/5119/003 12948 SANOFI OY FI

Tavanic 250 mg compresse rivestite con film DE/H/5119/001 033634027 SANOFI S.P.A IT

List of nationally authorised medicinal products EMA/397212/2019 Page 29/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 2628188

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

Tavanic 500 mg comprimidos recubiertos con película DE/H/5119/002 62065 SANOFI-AVENTIS, S.A. ES

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

Tavanic® 500 mg Filmtabletten DE/H/5119/002 41382.01.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 500 mg comprimidos recubiertos con película DE/H/5119/002 62065 SANOFI-AVENTIS, S.A. ES

TAVANIC 5 MG/ML SOLUZIONE PER INFUSIONE DE/H/5119/003 033634078 SANOFI S.P.A IT

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 3088085

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

List of nationally authorised medicinal products EMA/397212/2019 Page 30/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic® 500 mg Filmtabletten DE/H/5119/002 41382.01.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic® 500 mg Filmtabletten DE/H/5119/002 41382.01.00

SANOFI-AVENTIS DEUTSCHLAND GMBH DE

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

Tavanic 250 mg filmomhulde tabletten DE/H/5119/001 BE192866 SANOFI BELGIUM BE

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 2628089

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 3484680

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 250 mg comprimidos revestidos por película DE/H/5119/001 3088184

SANOFI - PRODUTOS FARMACEUTICOS LDA PT

TAVANIC 5 MG/ML INFUUSIONESTE, LIUOS DE/H/5119/003 12948 SANOFI OY FI

Tavanic 5 mg/ml oplossing voor infusie DE/H/5119/003 BE230237 SANOFI BELGIUM BE

List of nationally authorised medicinal products EMA/397212/2019 Page 31/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

TAVANIC 5 MG/ML INFUUSIONESTE, LIUOS DE/H/5119/003 12948 SANOFI OY FI

Tavanic 500 mg compresse rivestite con film DE/H/5119/002 033634092 SANOFI S.P.A IT

Tavanic 500 mg comprimidos recubiertos con película DE/H/5119/002 62065 SANOFI-AVENTIS, S.A. ES

Visuflox 5 mg/ml collirio, soluzione PT/H/1495/001 044459016 VISUFARMA SPA IT

Levofloxacin Actavis 5 mg/ml ögondroppar, lösning SE/H/1715/001 52248 ACTAVIS GROUP PTC EHF. SE

Levofloxacin Actavis 5 mg/ml silmatilgad, lahus SE/H/1715/001 905516 ACTAVIS GROUP PTC EHF. EE

Levofloxacin Actavis 5 mg/ml akių lašai (tirpalas) SE/H/1715/001 LT/1/16/3901/001 ACTAVIS GROUP PTC EHF. LT

Levofloxacină Actavis 5 mg/ml picături oftalmice, soluție UK/H/5960/001 8907/2016/01 ACTAVIS GROUP PTC EHF. RO

Levofloxacin Actavis 5 mg/ml acu pilieni, šķīdums SE/H/1715/001 16-0090 ACTAVIS GROUP PTC EHF. LV

List of nationally authorised medicinal products EMA/397212/2019 Page 32/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levofloxacin Actavis 5 mg/ml –silmätipat, liuos SE/H/1715/001 32926 ACTAVIS GROUP PTC EHF. FI

OFTAQUIX, 5 mg/ml, krople do oczu, roztwór not available 10825 SANTEN OY PL Oftaquix sine, 5 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym not available 17128 SANTEN OY PL

Levofloxacina Velka Hellas 5 mg/ml colírio, solução PT/H/1495/001 5691118 VELKA HELLAS S.A. PT

Oftaquix 5 mg/ml silmätipat, liuos, kerta-annospakkaus MRP UK/H/0464/002 23157 SANTEN OY FI

Oftaquix 5 mg/ml ögondroppar, lösning i endosbehållare MRP UK/H/0464/002 23157 SANTEN OY FI

Oftaquix 5 mg/ml ögondroppar, lösning i endosbehållare FI/H/0989/002 25042 SANTEN OY SE

Oftaquix, øjendråber, opløsning i enkeltdosisbeholder MRP UK/H/0464/002 40612 SANTEN OY DK

List of nationally authorised medicinal products EMA/397212/2019 Page 33/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Oftaquix 5 mg/ml augndropar, lausn stakskammtaílát FI/H/0989/002 IS/1/07/020/01 SANTEN OY IS Oftaquix Unit Dose 5 mg/ml eye drops, solution in single-dose container FI/H/0989/002 PL 16058/0007 SANTEN OY UK

Oftaquix sine 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis MRP UK/H/0464/002 67435.00.00 SANTEN OY DE

Oftaquix 5 mg/ml collirio, soluzione, contenitore monodose FI/H/0989/002 035728031 SANTEN OY IT

Oftaquix 5 mg/ml collirio, soluzione, contenitore monodose FI/H/0989/002 035728029 SANTEN OY IT

Oftaquix 5 mg/ml collirio, soluzione, contenitore monodose FI/H/0989/002 035728043 SANTEN OY IT

Oftaquix 5 mg/ml collirio, soluzione, contenitore monodose FI/H/0989/002 035728056 SANTEN OY IT

Офтакуикс 5 mg/ml очни капки Oftaquix 5 mg/ml eye drops not available 20040266 SANTEN OY BG

List of nationally authorised medicinal products EMA/397212/2019 Page 34/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

PRIXAR not available 033633037 SANOFI SPA IT

PRIXAR not available 033633049 SANOFI SPA IT

Prixar 250 mg compresse rivestite con film not available 033633013 SANOFI SPA IT

PRIXAR not available 033633052 SANOFI SPA IT

Prixar 250 mg compresse rivestite con film not available 033633025 SANOFI SPA IT

Levofloxacin UNIMED PHARMA 5 mg/ml silmatilgad, lahus HU/H/0449/001 933917 UNIMED PHARMA SPOL.S R.O. EE

Levofloxacin UNIMED PHARMA 5 mg/ml oldatos szemcsepp HU/H/0449/001 OGYI-T-23155/01 UNIMED PHARMA SPOL.S R.O. HU

Levofloxacin UNIMED PHARMA 5 mg/ml acu pilieni, šķīdums HU/H/0449/001 17-0057 UNIMED PHARMA SPOL.S R.O. LV

Levofloxacin UNIMED PHARMA 5 mg/ml akių lašai (tirpalas) HU/H/0449/001 LT/1/17/4044/001 UNIMED PHARMA SPOL.S R.O. LT

List of nationally authorised medicinal products EMA/397212/2019 Page 35/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levofloxacin UNIMED PHARMA, 5 mg/ml, krople do oczu, roztwór HU/H/0449/001 24081 UNIMED PHARMA SPOL.S R.O. PL

Levofloksacin UNIMED PHARMA 5 mg/ml kapljice za oko, raztopina HU/H/0449/001 H/17/02355/001 UNIMED PHARMA SPOL.S R.O. SI

Levofloxacin 5mg/ml Eye Drops Solution UK/H/5960/001 PL 0142/0946 ACTAVIS UK LTD. UK

Levofloxacin 5mg/ml Eye Drops Solution UK/H/5960/001 PL 0142/0946 ACTAVIS UK LTD. UK

Levofloxacina NTC 5 mg/ml colírio PT/H/1738/001 PT/H/1738/001 NTC SRL PT

Levoxacin 250 mg compresse rivestite con film not available 033940014 GLAXOSMITHKLINE S.P.A. IT

Levoxacin 250 mg compresse rivestite con film not available 033940026 GLAXOSMITHKLINE S.P.A. IT

Levoxacin 500 mg compresse rivestite con film not available 033940038 GLAXOSMITHKLINE S.P.A. IT

Levoxacin 500 mg compresse rivestite con film not available 033940040 GLAXOSMITHKLINE S.P.A. IT

List of nationally authorised medicinal products EMA/397212/2019 Page 36/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levoxacin 500 mg compresse rivestite con film not available 033940053 GLAXOSMITHKLINE S.P.A. IT

Levoxacin 5 mg/ml soluzione per infusione not available 033940065 GLAXOSMITHKLINE S.P.A. IT

Levodrop 5 mg/ml collirio, soluzione PT/H/0822/001 042149017

ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE VIA FRATELLI IT

Levofloxacina Optacare 5 mg/ml colírio PT/H/0822/001 5593173 NTC SRL PT

Levofloxacin 5 mg/ml eye drops solution PT/H/1495/001 PL35533/0069 ASPIRE PHARMA LIMITED UK

LEVOFLOXACIN/GENERICS 500 mg/100 ml, διάλυμα προς έγχυση UK/H/5634/002 21707 MYLAN S.A.S CY

Levofloxacine Mylan 500 mg/100 ml Infusionslösung UK/H/5634/002 BE355625 MYLAN BVBA/SPRL BE

Levofloxacine Mylan 500 mg/100 ml solution pour perfusion UK/H/5634/002 BE355625 MYLAN BVBA/SPRL BE

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/01 MYLAN S.A.S RO

List of nationally authorised medicinal products EMA/397212/2019 Page 37/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/02 MYLAN S.A.S RO

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/03 MYLAN S.A.S RO

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/04 MYLAN S.A.S RO

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/05 MYLAN S.A.S RO

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/06 MYLAN S.A.S RO

Levofloxacină Mylan 500 mg/100 ml soluţie perfuzabilă UK/H/5634/002 5900/2013/07 MYLAN S.A.S RO

LEVOFLOXACIN/GENERICS 500 mg/100 ml, διάλυμα προς έγχυση UK/H/5634/001 51161/13-07-2011

GENERICS PHARMA HELLAS LTD GR

Levofloxacine Mylan 500 mg/100 ml oplossing voor infusie UK/H/5634/002 BE355625 MYLAN BVBA/SPRL BE

Levofloxacin Mylan 250 mg/50 ml, solution for infusion UK/H/5634/001 MA767/00201 MYLAN S.A.S MT

List of nationally authorised medicinal products EMA/397212/2019 Page 38/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levofloxacin 250 mg/50 ml, solution for infusion UK/H/5634/001 PL 04569/1010 GENERICS [UK] LIMITED UK

Levofloxacin Arcana 500 mg/100 ml Infusionslösung UK/H/5634/002 1-29240 ARCANA ARZNEIMITTEL GMBH AT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326011 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326023 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326035 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326047 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326050 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326062 MYLAN S.P.A. IT

Levofloxacina Mylan 500 mg/100 ml soluzione per infusione UK/H/5634/002 040326074 MYLAN S.P.A. IT

List of nationally authorised medicinal products EMA/397212/2019 Page 39/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Levofloxacina Mylan 5 mg/ mL solução para perfusão UK/H/5634/002 5270624 MYLAN, LDA PT

Levofloxacina Mylan 5 mg/ml solução para perfusão UK/H/5634/002 5270632 MYLAN, LDA PT

Levofloxacin Mylan 500 mg/100 ml infuzní roztok UK/H/5634/002 42/894/09-C MYLAN S.A.S CZ

Levofloxacin Mylan 500 mg/100 ml, solution for infusion UK/H/5634/002 MA767/00202 MYLAN S.A.S MT

Levofloxacin 500 mg/100 ml, solution for infusion UK/H/5634/002 PL 04569/1011 GENERICS [UK] LIMITED UK

Levofloxacine Mylan 5 mg/ml, oplossing voor infusie UK/H/5634/001 RVG 104110 MYLAN B.V. NL

TAVANIC 250 mg comprimate filmate 942/2008/01-04 Terapia SA RO

TAVANIC 500 mg comprimate filmate 943/2008/01-02-03 Terapia SA RO

Tavanic i.v. 250 mg soluţie perfuzabilă 1016/2008/01 Terapia SA RO

List of nationally authorised medicinal products EMA/397212/2019 Page 40/40

Product Name (in authorisation country)

MRP/DCP Authorisation number National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tavanic i.v. 500 mg soluţie perfuzabilă 1017/2008/01 Terapia SA RO