12 April 2018 EMA/231706/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: fluocinolone acetonide (intravitreal implant in applicator)

Procedure no.: PSUSA/00010224/201708

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

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

ILUVIEN 190 microgram,

UK/H/3011/001

RVG 115058

ALIMERA SCIENCES LIMITED

NL

UK/H/3011/001

RVG 115058

ALIMERA SCIENCES LIMITED

NL

UK/H/3011/001

RVG 115058

ALIMERA SCIENCES LIMITED

NL

UK/H/3011/001

5436613

ALIMERA SCIENCES LIMITED

PT

UK/H/3011/001

5436613

ALIMERA SCIENCES LIMITED

PT

UK/H/3011/001

5436613

ALIMERA SCIENCES LIMITED

PT

UK/H/3011/001

NL 40191

ALIMERA SCIENCES LIMITED

FR

UK/H/3011/001

NL 40191

ALIMERA SCIENCES LIMITED

FR

UK/H/3011/001

NL 40191

ALIMERA SCIENCES LIMITED

FR

intravitreaal implant in applicator ILUVIEN 190 microgram, intravitreaal implant in applicator ILUVIEN 190 microgram, intravitreaal implant in applicator ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgrammes, implant intravitréen avec applicateur List of nationally authorised medicinal products EMA/231706/2018

Page 2/8

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

ILUVIEN 190

UK/H/3011/001

042616019

ALIMERA SCIENCES LIMITED

IT

UK/H/3011/001

042616019

ALIMERA SCIENCES LIMITED

IT

UK/H/3011/001

042616019

ALIMERA SCIENCES LIMITED

IT

UK/H/3011/001

76832

ALIMERA SCIENCES LIMITED

ES

UK/H/3011/001

76832

ALIMERA SCIENCES LIMITED

ES

UK/H/3011/001

76832

ALIMERA SCIENCES LIMITED

ES

UK/H/3011/001

PA1953/001/001

ALIMERA SCIENCES LIMITED

IE

UK/H/3011/001

PA1953/001/001

ALIMERA SCIENCES LIMITED

IE

microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgramos implante intravítreo en aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator

List of nationally authorised medicinal products EMA/231706/2018

Page 3/8

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

ILUVIEN 190 micrograms

UK/H/3011/001

PA1953/001/001

ALIMERA SCIENCES LIMITED

IE

UK/H/3011/001

53822

ALIMERA SCIENCES LIMITED

DK

UK/H/3011/001

53822

ALIMERA SCIENCES LIMITED

DK

UK/H/3011/001

53822

ALIMERA SCIENCES LIMITED

DK

UK/H/3011/001

14-9997

ALIMERA SCIENCES LIMITED

NO

UK/H/3011/001

14-9997

ALIMERA SCIENCES LIMITED

NO

UK/H/3011/001

14-9997

ALIMERA SCIENCES LIMITED

NO

UK/H/3011/001

50888

ALIMERA SCIENCES LIMITED

SE

UK/H/3011/001

50888

ALIMERA SCIENCES LIMITED

SE

intravitreal implant in applicator ILUVIEN 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 mikrogram intravitrealt implantat i applikator ILUVIEN 190 mikrogram intravitrealt implantat i applikator Iluvien 190 mikrogram intravitrealt implantat i applikator Iluvien 190 mikrogram intravitrealt implantat i applikator

List of nationally authorised medicinal products EMA/231706/2018

Page 4/8

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

Iluvien 190 mikrogram

UK/H/3011/001

50888

ALIMERA SCIENCES LIMITED

SE

UK/H/3011/001

1-31220

ALIMERA SCIENCES LIMITED

AT

UK/H/3011/001

1-31220

ALIMERA SCIENCES LIMITED

AT

UK/H/3011/001

1-31220

ALIMERA SCIENCES LIMITED

AT

PL 27813/0001

82809.00.00

ALIMERA SCIENCES LIMITED

DE

PL 27813/0001

82809.00.00

ALIMERA SCIENCES LIMITED

DE

PL 27813/0001

82809.00.00

ALIMERA SCIENCES LIMITED

DE

intravitrealt implantat i applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator

List of nationally authorised medicinal products EMA/231706/2018

Page 5/8

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

ILUVIEN 190

UK/H/3011/001

2014120387

ALIMERA SCIENCES LIMITED

LU

UK/H/3011/001

2014120387

ALIMERA SCIENCES LIMITED

LU

UK/H/3011/001

2014120387

ALIMERA SCIENCES LIMITED

LU

UK/H/3011/001

32121

ALIMERA SCIENCES LIMITED

FI

UK/H/3011/001

32121

ALIMERA SCIENCES LIMITED

FI

UK/H/3011/001

32121

ALIMERA SCIENCES LIMITED

FI

UK/H/3011/001

64/016/15-C

ALIMERA SCIENCES LIMITED

CZ

Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru

List of nationally authorised medicinal products EMA/231706/2018

Page 6/8

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

ILUVIEN 190 mikrogramů

UK/H/3011/001

64/016/15-C

ALIMERA SCIENCES LIMITED

CZ

UK/H/3011/001

64/016/15-C

ALIMERA SCIENCES LIMITED

CZ

UK/H/3011/001

22358

ALIMERA SCIENCES LIMITED

PL

UK/H/3011/001

22358

ALIMERA SCIENCES LIMITED

PL

UK/H/3011/001

22358

ALIMERA SCIENCES LIMITED

PL

UK/H/3011/001

BE465662

ALIMERA SCIENCES LIMITED

BE

UK/H/3011/001

BE465662

ALIMERA SCIENCES LIMITED

BE

UK/H/3011/001

BE465662

ALIMERA SCIENCES LIMITED

BE

intravitreální implantát v aplikátoru ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN190 microgrammes, implant intravitréen avec applicateur ILUVIEN190 microgrammes, implant intravitréen avec applicateur ILUVIEN190 microgrammes, implant

List of nationally authorised medicinal products EMA/231706/2018

Page 7/8

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

UK/H/3011/001

PL 41472/0001

ALIMERA SCIENCES LIMITED

UK

UK/H/3011/001

PL 41472/0001

ALIMERA SCIENCES LIMITED

UK

UK/H/3011/001

PL 41472/0001

ALIMERA SCIENCES LIMITED

UK

intravitréen avec applicateur ILUVIEN190 micrograms intravitreal implant in applicator ILUVIEN190 micrograms intravitreal implant in applicator ILUVIEN190 micrograms intravitreal implant in applicator

List of nationally authorised medicinal products EMA/231706/2018

Page 8/8

fluocinolone acetonide (intravitreal implant in applicator) - European ...

Apr 12, 2018 - Human Medicines Evaluation Division. List of nationally authorised medicinal products ... List of nationally authorised medicinal products. EMA/231706/2018. Page 3/8. Product Name (in authorisation country). MRP/DCP. Authorisation number. National Authorisation Number. MAH of product in the member ...

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