11 January 2018 EMA/24042/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: fluorescein (systemic use)

Procedure no.: PSUSA/00009153/201704

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

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Fluorescein Théa 500 mg/5 ml

not available

20010285

SERB SA

BG

not available

319028-3

SERB SA

FR

not available

320337-6

SERB SA

FR

not available

201130045

SERB SA

LU

not available

BE162811

SERB SA

BE

not available

BE162811

SERB SA

BE

not available

BE162811

SERB SA

BE

DE/H/0746/001

PL 00101/0989

NOVARTIS

UK

solution fort injection FLUORESCEINE SODIQUE FAURE 10 POUR CENT, solution injectable FLUORESCEINE SODIQUE FAURE 10 POUR CENT, solution injectable Fluorescéine 10 % Faure solution injectable FLUORESCEINE 10% Faure solution injectable FLUORESCEINE 10% Faure oplossing voor injectie FLUORESCEINE 10% Faure Injektionlösung Anatera 100 mg/ml solution for injection

PHARMACEUTICALS UK LIMITED

Fluorescite 100 mg/ml oldatos

not available

OGYI-T- 20 618/01

ALCON HUNGARIAN LTD.

HU

DE/H/0746/001

5021464

ALCON PORTUGAL -

PT

injekció Fluorescite 100 mg/ml solução injectável

PRODUTOS E EQUIPAMENTOS OFTALMOLÓGICOS, LDA.

FLUORESCITE 100 mg/ml

DE/H/0746/001

LT/1/07/0735/001

SA ALCON-COUVREUR NV

LT

Fluorescite 100 mg/ml süstelahus

DE/H/0746/001

542107

SA ALCON-COUVREUR NV

EE

Fluorescite 100 mg/ml škidums

DE/H/0746/001

07-0131

SA ALCON-COUVREUR NV

LV

injekcinis tirpalas

injekcijam

List of nationally authorised medicinal products EMA/24042/2018

Page 2/3

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Fluorescite, 100 mg/ml, roztwór

DE/H/0746/001

12952

ALCON POLSKA SP. Z.O.O

PL

not available

PL 43956/0002

SERB SA

UK

not available

4017885

SERB SA

PT

not available

4017984

SERB SA

PT

not available

369 542-2

SERB

FR

not available

365 669-8

SERB

FR

not available

367 517-0

SERB

FR

not available

566 130-9

SERB

FR

not available

65.458

SERB SA

ES

not available

65.458

SERB SA

ES

not available

POZWOLENIE NR R/2896

SERB SA

PL

not available

OGYI-T-1675/01

SERB SA

HU

do wstrzykiwań Fluorescein Sodium 100 mg/ml, Solution for Injection Fluoresceína SERB 100 mg/ml solução injectável Fluoresceína SERB 100 mg/ml solução injectável FLUOCYNE 10%, solution injectable I.V. FLUOCYNE 10%, solution injectable I.V. FLUOCYNE 10%, solution injectable I.V. FLUOCYNE 10%, solution injectable I.V. Fluoresceína Oculos 10%, solución inyectable Fluoresceína Oculos 10%, solución inyectable Fluoresceine SERB 100 mg/ml (10%), roztwór do wstrzykiwan Fluorescein SERB 100 mg/ml oldatos injekció

List of nationally authorised medicinal products EMA/24042/2018

Page 3/3

fluorescein (systemic use) PSUSA 00009153 201704 - maintenance

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