30 November 2017 EMA/797779/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: latanoprost (products with paediatric indication)

Procedure no.: PSUSA/00001834/201704

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

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© European Medicines Agency, 2017. 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

Akistan 50

SE/H/1095/001

64/0080/13-S

PHARMASELECT

SK

mikrogramov/ml očná

INTERNATIONAL

roztoková instilácia

BETEILIGUNGS GMBH

Akistan 0,05 mg/ml

SE/H/1095/001

OGYI-T-22248/01

oldatos szemcsepp

PHARMASELECT

HU

INTERNATIONAL BETEILIGUNGS GMBH

Akistan 50

SE/H/1095/001

5453/2013/01

micrograme/ml picături

RO

INTERNATIONAL

oftalmice, soluţie Akistan 50 mikrogram/ml

PHARMASELECT BETEILIGUNGS GMBH

SE/H/1095/001

45460

ögondroppar, lösning

PHARMASELECT

SE

INTERNATIONAL BETEILIGUNGS GMBH

Akistan 50

SE/H/1095/001

1-31279

PHARMASELECT

Mikrogramm/ml

INTERNATIONAL

Augentropfen

BETEILIGUNGS GMBH

Akistan 50

SE/H/1095/001

84058.00.00

PHARMASELECT

Mikrogramm/ml

INTERNATIONAL

Augentropfen

BETEILIGUNGS GMBH

Akistan 50

SE/H/1095/001

5363-I-2366/12

mikrogramov/ml kapljice LT/1/12/2952/001

PHARMASELECT INTERNATIONAL

(tirpalas)

BETEILIGUNGS GMBH SE/H/1095/001

64/387/12-C

PHARMASELECT

mikrogramů/ml oční

INTERNATIONAL

kapky,roztok

BETEILIGUNGS GMBH

Akistan, 50

SI

BETEILIGUNGS GMBH SE/H/1095/001

mikrogramų/ml akių lašai Akistan 50

DE

INTERNATIONAL

za oko, raztopina Akistan 50

PHARMASELECT

AT

SE/H/1095/001

20362

PHARMASELECT

mikrogramów/ml, krople

INTERNATIONAL

do oczu, roztwór

BETEILIGUNGS GMBH

List of nationally authorised medicinal products EMA/797779/2017

LT

CZ

PL

Page 2/24

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

Arulatan 50

UK/H/1986/001

72964

DR. GERHARD MANN CHEM.-

ES

microgramos/ml, colirio

PHARM. FABRIK GMBH

en solución Gisolom 50 μg/ml eye

not available

22356

drops solution Jaskroptic 0,05 mg/ml

DELORBIS

CY

PHARMACEUTICALS LTD DE/H/4399/001

93873.00.00

VITAL PHARMA GMBH

DE

DE/H/4399/001

23467

VITAL PHARMA GMBH

PL

UK/H/1986/001

OGYI-T-21504/01

DR. GERHARD MANN CHEM.-

HU

Augentropfen, Lösung Jaskroptic, 0,05 mg/ml, krople do oczu, roztwór Lanotan 50 mikrogramm/ml oldatos

PHARM. FABRIK GMBH

szemcsepp Latacris 50 microgram/ml

IE/H/0216/001

PA 2122/001/001

NTC SRL

IE

IE/H/0216/001

PL 35730/0013

NTC SRL

UK

IE/H/0216/001

18946

SUN-FARM SP. Z.O.O.

PL

not available

1-31792

DERMAPHARM GMBH

AT

eye drops, solution Latacris 50 microgram/ml eye drops, solution Latacris, 50 mikrogramów/ml, krople do oczu, roztwór Latacris® 50 Mikrogramm/ml Augentropfen

List of nationally authorised medicinal products EMA/797779/2017

Page 3/24

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

Latadin 0,005% w/v

not available

92288/15/20-01-2016

ANFARM HELLAS SA

GR

not available

3659/20-01-2016

ANFARM HELLAS SA

GR

NL/H/1654/001

RVG 104319

PHARMASWISS ČESKÁ

NL

οφθαλμικές σταγόνες διάλυμα Latadin PF 0,005% w/v οφθαλμικές σταγόνες διάλυμα LATALUX 50 microgram/ml,

REPUBLIKA S.R.O.

oogdruppels, oplossing Latalux 50 mikrogrami/ml

NL/H/1654/001

10-0502

acu pilieni, šķīdums LATALUX 50

PHARMASWISS ČESKÁ

LV

REPUBLIKA S.R.O. NL/H/1654/001

64/0474/10-S

mikrogramov/ml očná

PHARMASWISS ČESKÁ

SK

REPUBLIKA S.R.O.

roztoková instilácia LATALUX 50

NL/H/1654/001

LT/1/10/2163/001

mikrogramų/ml akių lašai

PHARMASWISS ČESKÁ

LT

REPUBLIKA S.R.O.

(tirpalas) LATALUX 50

NL/H/1654/001

LT/1/10/2163/002

mikrogramų/ml akių lašai

PHARMASWISS ČESKÁ

LT

REPUBLIKA S.R.O.

(tirpalas) LATALUX 50

NL/H/1654/001

LT/1/10/2163/003

mikrogramų/ml akių lašai

PHARMASWISS ČESKÁ

LT

REPUBLIKA S.R.O.

(tirpalas) LATALUX 50

NL/H/1654/001

mikrogramů/ml oční

64/584/10-C

PHARMASWISS ČESKÁ

CZ

REPUBLIKA S.R.O.

kapky, roztok

List of nationally authorised medicinal products EMA/797779/2017

Page 4/24

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

Latalux, 50

NL/H/1654/001

17247

PHARMASWISS ČESKÁ

PL

mikrogramów/ml, krople

REPUBLIKA S.R.O.

do oczu, roztwór Latanelb 50

not available

85823.00.00

AXUNIO PHARMA GMBH

DE

not available

3196

NOVENDIA

GR

Mikrogramm/ml Augentropfen LATANISTON 0,005% w/v Oφθαλμικές σταγόνες,

PHARMACEUTICALS LTD

διάλυμα Latanomed® 50

IE/H/0216/001

80004.00.00

MIBE GMBH ARZNEIMITTEL

DE

SE/H/1283/001

52020

MYLAN AB

DK

Latanoprost ”Sandoz”

DE/H/2076/001

44410

SANDOZ A/S

DK

Latanoprost ”Stada”,

NL/H/1809/001

45622

STADA ARZNEIMITTEL AG

DK

NO/H/0139/001

PL 00289/1668

TEVA UK LIMITED

UK

UK/H/2707/001

PL 17918/0014

TUBILUX PHARMA S.P.A.

UK

Mikrogramm/ml Augentropfen Latanoprost ”Mylan”, øjendråber, opløsning

øjendråber, opløsning Latanoprost 0.005% w/v eye drops solution Latanoprost 0.005% w/v eye drops solution

List of nationally authorised medicinal products EMA/797779/2017

Page 5/24

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

Latanoprost 0.005% w/v

DE/H/2076/001

PL 04416/1051

SANDOZ LTD

UK

DE/H/2076/001

75073.00.00

1 A PHARMA GMBH

DE

UK/H/4549/001

PL 35638 /0003

FDC PHARMA

UK

UK/H/5209/001

PL 18157/0254

BEACON PHARMACEUTICALS

UK

eye drops, Solution Latanoprost- 1 A Pharma 50 Mikrogramm/ml Augentropfen, Lösung Latanoprost 50 micrograms / ml Eye Drops, Solution. Latanoprost 50 micrograms/ml eye drops

LIMITED

solution Latanoprost 50

SE/H/1283/001

PA0405/068/001

GENERICS [UK] LIMITED

IE

UK/H/5496/001

PL 24598/0045

NORIDEM ENTERPRISES LTD

UK

ES/H/0328/01

71.100

ABAMED PHARMA, S.L.

ES

not available

86005.00.00

ABZ-PHARMA GMBH

DE

NL/H/1810/001

79742.00.00

ALIUD PHARMA GMBH

DE

micrograms/ml eye drops, solution Latanoprost 50 micrograms/ml eye drops, solution Latanoprost Abamed 50 microgramos/ml colirio en solución. Latanoprost AbZ 50 Mikrogramm/ml Augentropfen Latanoprost AL 50 Mikrogramm/ml Augentropfen

List of nationally authorised medicinal products EMA/797779/2017

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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

LATANOPROST ARROW

PL/H/0386/001

35 113

ARROW GENERIQUES

FR

PL/H/0386/001

70721

ARROW GENERICS LIMITED

ES

NO/H/0141/001

15640

ACTAVIS GROUP PTC EHF.

PL

PL/H/0386/001

RVG 101423

AUROBINDO PHARMA B.V.

NL

NL/H/1382/001

71.098

AUROVITAS SPAIN,S.A.U.

ES

PT/H/0544/001

5318746

BRUSCHETTINI S.R.L

PT

NL/H/1809/001

RVG 105910

CENTRAFARM B.V.

NL

NL/H/1809/001

5371117

CICLUM FARMA UNIPESSOAL

PT

0,005 %, collyre en solution Latanoprost Arrow 50 microgramos/ml colirio en solución Latanoprost Arrow, 50 mikrogramów/ml, krople do oczu, roztwór Latanoprost Aurobindo 50 microgram/ml, oogdruppels, oplossing Latanoprost Aurovitas 50 microgramos/ml colirio en solución LATANOPROST BRUSCHETTINI 50 μg / ml colírio, solução Latanoprost CF 50 microgram/ml oogdruppels, oplossing Latanoprost Ciclum 50 microgramas/ml colírio,

LDA.

solução Latanoprost Ciclum 50

NL/H/1809/001

microgramas/ml colírio,

5371109

CICLUM FARMA UNIPESSOAL

PT

LDA.

solução

List of nationally authorised medicinal products EMA/797779/2017

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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

Latanoprost Ciclum 50

NL/H/1809/001

NL/H/1809/001

CICLUM FARMA UNIPESSOAL

PT

microgramas/ml colírio,

LDA.

solução LATANOPROST CINFA 50

UK/H/2707/001/DC

73959

LABORATORIOS CINFA, S.A.

ES

NL/H/1948/001

75.082

LABORATORIOS COMBIX,

ES

MICROGRAMOS/ML COLIRIO EN SOLUCIÓN Latanoprost Combix 50 microgramos/ml colirio

S.L.U.

en solución Latanoprost DEMO 50

UK/H/5496/001

91614.00.00

DEMO S.A.

DE

NL/H/1809/001

NL38465

EG LABO - LABORATOIRES

FR

Mikrogramm/ml Augentropfen, Lösung LATANOPROST EG 0,005 %, collyre en

EUROGENERICS

solution Latanoprost EG 50

NL/H/1809/001

BE381525

EUROGENERICS SA

BE

NL/H/1809/001

BE381525

EUROGENERICS SA

BE

NL/H/1809/001

2012030044

EUROGENERICS N.V./S.A.

LU

NL/H/1809/001

BE381525

EUROGENERICS SA

BE

microgram/ml oogdruppels, oplossing Latanoprost EG 50 microgrammes/ml collyre en solution Latanoprost EG 50 microgrammes/ml collyre en solution Latanoprost EG 50 Mikrogramm/ml Augentropfen, Lösung

List of nationally authorised medicinal products EMA/797779/2017

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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

Latanoprost FDC Pharma

UK/H/4549/001

76568

FDC PHARMA

ES

UK/H/4549/001

84694.00.00

FDC PHARMA

DE

NL/H/1948/001

19537

SYNOPTIS PHARMA SP Z O O

PL

DE/H/2075/001

75071.00.00

HEXAL AG

DE

not available

LT/1/12/2933/001

SIA INGEN PHARMA

LT

not available

LT/1/12/2933/002

SIA INGEN PHARMA

LT

DE/H/1999/001

75006.00.00

MALCOSA LTD

DE

not available

73520

MEDICAL MIX S.L.

ES

50 microgramos/ml colirio en solución Latanoprost FDC Pharma 50 Mikrogramm / ml Augentropfen Latanoprost Genoptim, 50 mikrogramów/ml, krople do oczu, roztwór Latanoprost HEXAL 50 Mikrogramm/ml Augentropfen, Lösung Latanoprost Ingen Pharma 50 mikrogramų/ml akių lašai (tirpalas) Latanoprost Ingen Pharma 50 mikrogramų/ml akių lašai (tirpalas) Latanoprost Malcosa 50 Mikrogramm/ml Augentropfen Latanoprost Medical Mix 50 microgramos/ml colirio en solución

List of nationally authorised medicinal products EMA/797779/2017

Page 9/24

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

Latanoprost Mylan 0,05

SE/H/1283/001

5630546

MYLAN, LDA

PT

SE/H/1283/001

5630538

MYLAN, LDA

PT

SE/H/1283/001

5630553

MYLAN, LDA

PT

SE/H/1283/001

64/294/14-C

GENERICS [UK] LIMITED

CZ

SE/H/1283/001

RVG 113160

MYLAN B.V.

NL

SE/H/1283/001

042620017

MYLAN S.P.A.

IT

SE/H/1283/001

042620029

MYLAN S.P.A.

IT

SE/H/1283/001

042620031

MYLAN S.P.A.

IT

SE/H/1283/001

13-9428

MYLAN AB

NO

mg/ml colírio, solução Latanoprost Mylan 0,05 mg/ml colírio, solução Latanoprost Mylan 0,05 mg/ml colírio, solução Latanoprost Mylan 0,05 mg/ml oční kapky, roztok Latanoprost Mylan 0,05 mg/ml, oogdruppels, oplossing Latanoprost Mylan 50 microgrammi/ml collirio, soluzione Latanoprost Mylan 50 microgrammi/ml collirio, soluzione Latanoprost Mylan 50 microgrammi/ml collirio, soluzione Latanoprost Mylan 50 mikrogram/ml øyedråper, oppløsning

List of nationally authorised medicinal products EMA/797779/2017

Page 10/24

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

Latanoprost Mylan 50

SE/H/1283/001

48953

MYLAN AB

SE

SE/H/1283/001

IS/1/14/041/01

MYLAN AB

IS

UK/H/5496/001

BE508951

NORIDEM ENTERPRISES LTD

BE

NL/H/1876/001

RVG 106488

NTC SRL

NL

NL/H/1876/001

041375015

NTC SRL

IT

NL/H/1876/001

041375027

NTC SRL

IT

NL/H/1876/001

041375039

NTC SRL

IT

NL/H/1876/001

11-0323

NTC SRL

LV

NL/H/1876/001

LT/1/11/2686/002

NTC SRL

LT

mikrogram/ml, ögondroppar, lösning Latanoprost Mylan 50 míkrógrömm/ml augndropar, lausn Latanoprost Noridem 50 microgrammes/mL, collyre en solution Latanoprost NTC 50 microgram/ml, oogdruppels, oplossing LATANOPROST NTC 50 microgrammi/ml collirio, soluzione LATANOPROST NTC 50 microgrammi/ml collirio, soluzione LATANOPROST NTC 50 microgrammi/ml collirio, soluzione Latanoprost NTC 50 mikrogrami/ml acu pilieni, šķīdums Latanoprost NTC 50 mikrogramų/ml akių lašai, tirpalas

List of nationally authorised medicinal products EMA/797779/2017

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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

Latanoprost NTC 50

NL/H/1876/001

LT/1/11/2686/003

NTC SRL

LT

NL/H/1876/001

LT/1/11/2686/001

NTC SRL

LT

not available

OGYI-T-21936/01

PFIZER KFT.

HU

not available

OGYI-T-21936/02

PFIZER KFT.

HU

NL/H/2052/001

RVG 107731

RANBAXY (UK) LIMITED

NL

NL/H/2052/001

NL 40087

RANBAXY PHARMACIE

FR

mikrogramų/ml akių lašai, tirpalas Latanoprost NTC 50 mikrogramų/ml akių lašai, tirpalas Latanoprost Pfizer 0,05 mg/ml oldatos szemcsepp Latanoprost Pfizer 0,05 mg/ml oldatos szemcsepp Latanoprost Ranbaxy 50 microgram/ml oogdruppels, oplossing LATANOPROST RANBAXY 50 microgrammes/ml,

GENERIQUES

collyre en solution Latanoprost ratiopharm

NO/H/0139/001

24330

RATIOPHARM GMBH

FI

NO/H/0139/001

07-5388

RATIOPHARM GMBH

NO

NO/H/0139/001

1-28392

RATIOPHARM ARZNEIMITTEL

AT

50 mikrog/ml silmatipat, liuos Latanoprost ratiopharm 50 mikrogram/ml, øyedråper, oppløsning Latanoprost ratiopharm 50 Mikrogramm/ml

VERTRIEBS-GMBH

Augentropfen

List of nationally authorised medicinal products EMA/797779/2017

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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

Latanoprost Sandoz 0,05

DE/H/2076/001

BE393985

SANDOZ N.V.

BE

DE/H/2076/001

RVG 104079

SANDOZ B.V.

NL

DE/H/2076/001

34009 219 375 3 4

SANDOZ

FR

DE/H/2076/001

34009 219 377 6 3

SANDOZ

FR

DE/H/2076/001

34009 219 378 2 4

SANDOZ

FR

DE/H/2076/001

74523

SANDOZ FARMACÉUTICA,

ES

mg/ml oogdruppels, oplossing Latanoprost Sandoz 0,05 mg/ml, oogdruppels, oplossing LATANOPROST SANDOZ 50 microgrammes/ml, collyre en solution LATANOPROST SANDOZ 50 microgrammes/ml, collyre en solution LATANOPROST SANDOZ 50 microgrammes/ml, collyre en solution Latanoprost Sandoz 50 microgramos/ml colirio

S.A.

en solución Latanoprost Sandoz 50

DE/H/2076/001

27104

SANDOZ A/S

FI

DE/H/2076/001

41820

SANDOZ A/S

SE

DE/H/2076/001

08-6413

SANDOZ A/S

NO

mikrog/ml silmätipat, liuos Latanoprost Sandoz 50 mikrogram/ml ögondroppar, lösning Latanoprost Sandoz 50 mikrogram/ml øyedråper, oppløsning.

List of nationally authorised medicinal products EMA/797779/2017

Page 13/24

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

Latanoprost Sandoz 50

DE/H/2076/001

1-30546

SANDOZ GMBH

AT

NL/H/1810/001

RVG 105912

STADA ARZNEIMITTEL AG

NL

NL/H/1408/001

71103

LABORATORIO STADA, S.L.

ES

NL/H/1809/001

43052

STADA ARZNEIMITTEL AG

SE

NL/H/1809/001

1-30255

STADA ARZNEIMITTEL GMBH

AT

NL/H/3195/001

64/382/15-C

STADA ARZNEIMITTEL AG

CZ

NL/H/1809/001

5786/2013/01

STADA HEMOFARM S.R.L.

RO

NL/H/1809/001

5786/2013/02

STADA HEMOFARM S.R.L.

RO

NL/H/1809/001

5786/2013/03

STADA HEMOFARM S.R.L.

RO

Mikrogramm/ml Augentropfen Latanoprost STADA 50 microgram/ml oogdruppels, oplossing Latanoprost STADA 50 microgramos/ml colirio en solución Latanoprost STADA 50 mikrogram/ml, ögondroppar, lösning Latanoprost STADA 50 Mikrogramm/ml Augentropfen Latanoprost STADA 50 mikrogramů/ml oční kapky, roztok Latanoprost STADA HF 50 micrograme/ml picături oftalmice, soluţie Latanoprost STADA HF 50 micrograme/ml picături oftalmice, soluţie Latanoprost STADA HF 50 micrograme/ml picături oftalmice, soluţie

List of nationally authorised medicinal products EMA/797779/2017

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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

Latanoprost STADA, 50

NL/H/1809/001

18283

STADA ARZNEIMITTEL AG

PL

NL/H/1809/001

79707.00.00

STADAPHARM GMBH

DE

NL/H/1876/001

75539

TARBIS FARMA, S.L.

ES

Latanoprost Teva

NO/H/0139/001

42427

TEVA DENMARK A/S

DK

Latanoprost Teva 50

NO/H/0139/001

5436647

TEVA PHARMA – PRODUTOS

PT

mikrogramów/ml, krople do oczu, roztwór Latanoprost STADA® 50 Mikrogramm/ml Augentropfen Latanoprost TARBIS 50 microgramos/ml colirio en solución

microgramas/ml colírio,

FARMACÊUTICOS LDA

solução Latanoprost Teva 50

NO/H/0139/001

71221

TEVA PHARMA S.L.U

ES

NO/H/0139/001

PA0749/173/001

TEVA PHARMA B.V.

IE

NO/H/0139/001

RVG 101418

TEVA NEDERLAND B.V.

NL

NO/H/0139/001

26305

TEVA SWEDEN AB

SE

microgramos/ml colirio en solución Latanoprost Teva 50 micrograms/ml eye drop solution Latanoprost Teva 50 μg/ml, oogdruppels, oplossing Latanoprost Teva, 50 mikrogram/ml ögondroppar, lösning

List of nationally authorised medicinal products EMA/797779/2017

Page 15/24

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

Latanoprost TRB 50

DE/H/4788/001/DC

84610.00.00

TRB CHEMEDICA AG

DE

NL/H/1875/001

RVG 106487

URSAPHARM BENELUX B.V.

NL

NO/H/0139/001

71970.00.00

RATIOPHARM GMBH

DE

NO/H/0139/001

09-0121

RATIOPHARM GMBH

LV

NO/H/0139/001

LT/1/09/1544/001

RATIOPHARM GMBH

LT

NO/H/0139/001

LT/1/09/1544/002

RATIOPHARM GMBH

LT

NO/H/0139/001

LT/1/09/1544/003

RATIOPHARM GMBH

LT

NO/H/0139/001

64/237/09-C

RATIOPHARM GMBH

CZ

NO/H/0139/001

626609

RATIOPHARM GMBH

EE

Mikrogramm/ml Augentropfen Latanoprost-POS 50 microgram/ml, oogdruppels, oplossing Latanoprost-ratiopharm 50 Mikrogramm/ml Augentropfen Latanoprost-ratiopharm 50 mikrogramu/ml acu pilieni, šķīdums Latanoprost-ratiopharm 50 mikrogramų/ml akių lašai (tirpalas) Latanoprost-ratiopharm 50 mikrogramų/ml akių lašai (tirpalas) Latanoprost-ratiopharm 50 mikrogramų/ml akių lašai (tirpalas) Latanoprost-ratiopharm 50 μg/ml Oční kapky, roztok Latanoprost-ratiopharm, 50 mikrogrammi/ml silmatilgad, lahus

List of nationally authorised medicinal products EMA/797779/2017

Page 16/24

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

Latanoprost-ratiopharm®

NO/H/0139/001

0687/10040028

RATIOPHARM GMBH

LU

NL/H/3195/001

RVG 115407

STADA ARZNEIMITTEL AG

NL

PT/H/0544/001

042281016/M

BRUSCHETTINI S.R.L

IT

AT/H/0450/001/DC

1-30741

OMNIVISION GMBH

AT

AT/H/0450/001/DC

82805.00.00

OMNIVISION GMBH

DE

DE/H/2075/001

PA 711/177/1

ROWEX LTD

IE

NL/H/1809/001

27906

STADA ARZNEIMITTEL AG

FI

NL/H/1948/001

RVG 106489

NTC SRL

NL

DE/H/1999/001

12137/3-2-14

PHARMEX S.A.

GR

50 Mikrogramm/ml Augentropfen Latanostad 50 microgram/ml oogdruppels, oplossing Latanostill Latanoprost 50microgrammi/ml collirio, soluzione Latano-Vision 50 Mikrogramm/ml Augentropfen, Lösung Latano-Vision 50 Mikrogramm/ml Augentropfen, Lösung Latop 50 microgram/ml eye drops, solution Oftastad 50 mikrog/ml silmätipat, liuos Optopress 50 microgram/ml, oogdruppels, oplossing PHARMAPROST 50microgram/ml οφθαλμικές σταγόνες διάλυμα

List of nationally authorised medicinal products EMA/797779/2017

Page 17/24

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

Polprost, 50

DE/H/2076/001

18344

SANDOZ GMBH

PL

PL/H/0386/001

PA 1380/161/1

ACTAVIS GROUP PTC EHF.

IE

NL/H/2589/001

21703

ADAMED

PL

NL/H/1876/001

3903/2011/01

NTC SRL

RO

NL/H/1876/001

3903/2011/02

NTC SRL

RO

NL/H/1876/001

3903/2011/03

NTC SRL

RO

UK/H/0179/001

BE183967

PFIZER S.A. (BELGIUM)

BE

UK/H/0179/001

2009060447

PFIZER S.A. (BELGIUM)

LU

not available

LT/1/99/0417/001

PFIZER EUROPE MA EEIG

LT

mikrogramów/ml, krople do oczu, roztwór Proxal Actavis 50 µg/ml eye drops, solution Rozaprost Mono, 50 mikrogramów/mL, krople do oczu, roztwór SifiTan 50 micrograme/ml picături oftalmice, soluţie SifiTan 50 micrograme/ml picături oftalmice, soluţie SifiTan 50 micrograme/ml picături oftalmice, soluţie XALATAN 0,005 % Augentropfen, Lösung XALATAN 0,005 % Augentropfen, Lösung Xalatan 0,005% akių lašai (tirpalas)

List of nationally authorised medicinal products EMA/797779/2017

Page 18/24

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

Xalatan 0,05 mg/ml

not available

OGYI-T-5637/01

PFIZER KFT.

HU

not available

OGYI-T- 5637/02

PFIZER KFT.

HU

not available

64/0121/98-S

PFIZER EUROPE MA EEIG

SK

UK/H/0179/001

BE183967

PFIZER S.A. (BELGIUM)

BE

UK/H/0179/001

5226840

LABORATÓRIOS PFIZER,

PT

oldatos szemcsepp Xalatan 0,05 mg/ml oldatos szemcsepp XALATAN 50 µg/1 ml očná roztoková instilácia XALATAN 50 microgram/ml oogdruppels, oplossing Xalatan 50 microgramas/ml colírio,

LDA.

solução Xalatan 50

UK/H/0179/001

2547388

microgramas/ml colírio,

LABORATÓRIOS PFIZER,

PT

LDA.

solução Xalatan 50

UK/H/0179/001

5226857

microgramas/ml colírio,

LABORATÓRIOS PFIZER,

PT

LDA.

solução Xalatan 50

UK/H/0179/001

5226832

microgramas/ml colírio,

LABORATÓRIOS PFIZER,

PT

LDA.

solução Xalatan 50

UK/H/0179/001

microgramas/ml colírio,

2547487

LABORATÓRIOS PFIZER,

PT

LDA.

solução

List of nationally authorised medicinal products EMA/797779/2017

Page 19/24

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

Xalatan 50

not available

7107/2014/02

PFIZER EUROPE MA EEIG

RO

not available

7107/2014/04

PFIZER EUROPE MA EEIG

RO

not available

7107/2014/01

PFIZER EUROPE MA EEIG

RO

not available

7107/2014/03

PFIZER EUROPE MA EEIG

RO

UK/H/0179/001

BE183967

PFIZER S.A. (BELGIUM)

BE

UK/H/0179/001

2009060447

PFIZER S.A. (BELGIUM)

LU

UK/H/0179/001

34009 343840 6 6

PFIZER HOLDING FRANCE

FR

UK/H/0179/001

34009 343841 2 7

PFIZER HOLDING FRANCE

FR

UK/H/0179/001

033219027

PFIZER ITALIA S.R.L.

IT

micrograme/ml picături oftalmice, soluţie Xalatan 50 micrograme/ml picături oftalmice, soluţie Xalatan 50 micrograme/ml picături oftalmice, soluţie Xalatan 50 micrograme/ml picături oftalmice, soluţie XALATAN 50 microgrammes/ml collyre en solution XALATAN 50 microgrammes/ml collyre en solution XALATAN 50 microgrammes/ml, collyre en solution XALATAN 50 microgrammes/ml, collyre en solution XALATAN 50 microgrammi/ml collirio, soluzione

List of nationally authorised medicinal products EMA/797779/2017

Page 20/24

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

XALATAN 50

UK/H/0179/001

033219015

PFIZER ITALIA S.R.L.

IT

UK/H/0179/001

033219027

PFIZER ITALIA S.R.L.

IT

UK/H/0179/001

033219015

PFIZER ITALIA S.R.L.

IT

UK/H/0179/001

61.756

PFIZER, S.L.

ES

UK/H/0179/001

PA 822/140/1

PFIZER HEALTHCARE

IE

microgrammi/ml collirio, soluzione XALATAN 50 microgrammi/ml collirio, soluzione XALATAN 50 microgrammi/ml collirio, soluzione Xalatan 50 microgramos/ml colirio en solución Xalatan 50 micrograms/ml eye

IRELAND

drops, solution Xalatan 50

not available

MA505/02501

PFIZER HELLAS, A.E.

MT

UK/H/0179/001

PL 00057/1057

PFIZER LIMITED

UK

not available

980195

PFIZER APS

IS

UK/H/0179/001

12694

PFIZER OY

FI

micrograms/ml eye drops, solution Xalatan 50 micrograms/ml eye drops, solution Xalatan 50 míkróg/ml augndropar, lausn Xalatan 50 mikrog/ml ögondroppar, lösning

List of nationally authorised medicinal products EMA/797779/2017

Page 21/24

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

Xalatan 50 mikrog/ml

not available

95-2153

PFIZER AS

NO

UK/H/0179/001

12694

PFIZER OY

FI

not available

12716

PFIZER AB

SE

not available

UP/I-530-09/11-02/198

PFIZER CROATIA D.O.O.

HR

not available

00-0502

PFIZER EUROPE MA EEIG

LV

not available

H/98/01669/001

PFIZER LUXEMBOURG SARL

SI

UK/H/0179/001

20805

PFIZER HELLAS, A.E.

CY

UK/H/0179/001

32620/07/11-04-2008

PFIZER HELLAS, A.E.

GR

not available

64/164/99-C

PFIZER, SPOL. S R.O.

CZ

øyedråper, oppløsning Xalatan 50 mikrog/ml silmätipat, liuos Xalatan 50 mikrogram/ml, ögondroppar, lösning XALATAN 50 mikrograma/ml kapi za oko, otopina Xalatan 50 mikrogrami/ml acu pilieni, šķīdums Xalatan 50 mikrogramov/ml kapljice za oko, raztopina Xalatan 50 μικρογραμμάρια/ml οφθαλμικές σταγόνες, διάλυμα Xalatan 50 μικρογραμμάρια/ml οφθαλμικές σταγόνες, διάλυμα XALATAN Oční kapky,roztok

List of nationally authorised medicinal products EMA/797779/2017

Page 22/24

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

Xalatan, 50

not available

284899

PFIZER EUROPE MA EEIG

EE

not available

4118

PFIZER EUROPE MA EEIG

PL

UK/H/0179/001

18752

PFIZER APS

DK

UK/H/0179/001

RVG 21304

PFIZER B.V.

NL

UK/H/0179/001

1-22019

PFIZER CORPORATION

AT

mikrogrammi/ml silmatilgad, lahus Xalatan, 50 μg/ml, krople do oczu, roztwór Xalatan, øjendråber, opløsning Xalatan, oogdruppels, 50 microgram/ml Xalatan® 50 Mikrogramm/ml

AUSTRIA GESELLSCHAFT

Augentropfen

M.B.H.

Xalatan® 50

UK/H/0179/001

40466.00.00

PFIZER PHARMA PFE GMBH

DE

NL/H/3193/001

RVG 115290

GENETIC SPA

NL

NL/H/3193/001

22424

ZAKLADY FARMACEUTYCZNE

PL

Mikrogramm/ml Augentropfen Augentropfen, Lösung Xalmono 0,05 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik Xaloptic Free, 50 mikrogramów/ml, krople

"POLPHARMA" SPOLKA

do oczu, roztwór w

AKCYJNA

pojemniku jednodawkowym

List of nationally authorised medicinal products EMA/797779/2017

Page 23/24

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

XALOST 50

DE/H/1999/001

039795012

FARMIGEA SPA

IT

DE/H/1999/001

039795024

FARMIGEA SPA

IT

DE/H/1999/001

039795036

FARMIGEA SPA

IT

not available

46828/ 25-09-2013

PHARMAZAC SA

GR

SE/H/1095/001

20130062

PHARMASELECT

BG

microgrammi/ml collirio, soluzione XALOST 50 microgrammi/ml collirio, soluzione XALOST 50 microgrammi/ml collirio, soluzione ZAKOPROST® 0,005% w/v οφθαλμικές σταγόνες διάλυμα. Акистан 50 микрограма/ml капки за

INTERNATIONAL

очи, разтвор

BETEILIGUNGS GMBH

Ксалатан 50

not available

9900241

PFIZER ENTERPRISES SARL

BG

NL/H/1654/001

20100633

PHARMASWISS ČESKÁ

BG

микрограма/ml капки за очи, разтвор ЛАТАЛУКС 50 микрограма/ml капки за

REPUBLIKA S.R.O.

очи, разтвор

List of nationally authorised medicinal products EMA/797779/2017

Page 24/24

latanoprost - European Medicines Agency - Europa EU

Nov 30, 2017 - ES. Latanoprost Combix 50 microgramos/ml colirio en solución. NL/H/1948/001. 75.082. LABORATORIOS COMBIX,. S.L.U.. ES. Latanoprost DEMO 50. Mikrogramm/ml. Augentropfen, Lösung. UK/H/5496/001. 91614.00.00. DEMO S.A.. DE. LATANOPROST EG. 0,005 %, collyre en solution. NL/H/1809/001.

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