escitalopram PSUSA 001265-201612, Regulatory outcome ...

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01 September 2017 EMA/590630/2017 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: escitalopram

Procedure no.: PSUSA/00001265/201612

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, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

Escitalopram Mylan 5 mg Filmtabletten Escitalopram Mylan 10 mg Filmtabletten Escitalopram Mylan 20 mg Filmtabletten Escitalopram 10 mg film-coated tablets Escitalopram 20 mg film-coated tablets Escitalopram 5 mg film-coated tablets Escitil 15 mg filmtabletta

DE/H/0594/001

64451.00.00

DE/H/0594/002

64451.01.00

DE/H/0594/004

64451.03.00

DE/H/0594/002

PL 04569/0777

DE/H/0594/004

PL 04569/0778

DE/H/0594/001

PL 04569/0776

AT/H/0212/003/DC

OGYI-T-20966/07-09

Escitalopram Genedec 10 mg comprimidos orodispersíveis

not available

5673736

Escitalopram Genedec 10 mg comprimidos orodispersíveis

not available

5673744

Escitalopram Genedec 20 mg comprimidos orodispersíveis

not available

5673777

Escitalopram Genedec 20 mg comprimidos orodispersíveis

not available

5673801

Escitalopram beta 10 mg Filmtabletten

DE/H/3578/002

68165.00.00

Escitalopram beta 15 mg Filmtabletten

DE/H/3578/003

68166.00.00

Escitalopram beta 20 mg Filmtabletten

DE/H/3578/004

68167.00.00

List of nationally authorised medicinal products EMA/590630/2017

MAH of product in the member state MYLAN DURA GMBH MYLAN DURA GMBH MYLAN DURA GMBH GENERICS [UK] LIMITED GENERICS [UK] LIMITED GENERICS [UK] LIMITED EGIS PHARMACEUTICALS PLC GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. BETAPHARM ARZNEIMITTEL GMBH BETAPHARM ARZNEIMITTEL GMBH BETAPHARM ARZNEIMITTEL GMBH

Member State where product is authorised DE DE DE UK UK UK HU PT PT PT PT DE DE DE

Page 2/28

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

Escitalopram beta 5 mg Filmtabletten

DE/H/3578/001

68164.00.00

ESCITALOPRAM SANDOZ 15 mg tabletti, suussa hajoava ESCITALOPRAM SANDOZ 5 mg tabletti, suussa hajoava Escitalopram Sandoz 5 mg – Schmelztabletten Escitalopram Sandoz 15 mg – Schmelztabletten Escitalopram Sandoz 20 mg/ml – Tropfen zum Einnehmen, Lösung Esciprex DisTab 5 mg Orodispersible Tablets Esciprex DisTab 15 mg Orodispersible Tablets Escitalopram-neuraxpharm 10 mg Filmtabletten

PT/H/1134/003

MAH of product in the member state

Member State where product is authorised DE

31596

BETAPHARM ARZNEIMITTEL GMBH SANDOZ A/S

PT/H/1134/001

31594

SANDOZ A/S

FI

PT/H/1134/001

135734

SANDOZ GMBH

AT

PT/H/1134/003

135737

SANDOZ GMBH

AT

NL/H/2512/001

136143

SANDOZ GMBH

AT

PT/H/1134/001

PA0711/194/005

ROWEX LTD

IE

PT/H/1134/003

PA0711/194/007

ROWEX LTD

IE

DE/H/1174/002

69884.00.00

DE

Escitalopram-neuraxpharm 15 mg Filmtabletten

DE/H/1174/003

69885.00.00

Escitalopram-neuraxpharm 20 mg Filmtabletten

DE/H/1174/004

69886.00.00

Escitalopram-neuraxpharm 5 mg Filmtabletten

DE/H/1174/001

69883.00.00

Escitalopram Zentiva 20 mg comprimido revestido por película

UK/H/6146/004

5583265

Escitalopram Zentiva 10 mg comprimido revestido por

UK/H/6146/002

5583273

NEURAXPHARM ARZNEIMITTEL GMBH NEURAXPHARM ARZNEIMITTEL GMBH NEURAXPHARM ARZNEIMITTEL GMBH NEURAXPHARM ARZNEIMITTEL GMBH SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS

List of nationally authorised medicinal products EMA/590630/2017

FI

DE DE DE PT

PT

Page 3/28

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

película

MAH of product in the member state

ESCITALOPRAM ZENTIVA 10 MG COMPRIMIDO REVESTIDO POR PELICULA

UK/H/6146/002

5097225

ESCITALOPRAM ZENTIVA 10 MG COMPRIMIDO REVESTIDO POR PELICULA

UK/H/6146/002

5103478

Escitalopram Zentiva 20 mg comprimido revestido por película

UK/H/6146/004

5097241

Escitalopram Zentiva 20 mg comprimido revestido por película

UK/H/6146/004

5103510

ESCITALOPRAM ZENTIVA 10 MG COMPRIMIDO REVESTIDO POR PELICULA

UK/H/6146/002

5097233

ESCITALOPRAM ZENTIVA 10 MG COMPRIMIDO REVESTIDO POR PELICULA

UK/H/6146/002

5103502

Escitalopram 5 mg film-coated tablets Escitalopram 10 mg film-coated tablets Escitalopram 20 mg film-coated tablets ESCITALOPRAM ZENTIVA LAB 10 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 10

not available

PL 42930/0019

not available

PL 42930/0020

not available

PL 42930/0021

SE/H/0279/002

277 341-0

FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA SANOFI PRODUTOS FARMACEUTICOS LDA WILCARE PHARMA LIMITED WILCARE PHARMA LIMITED WILCARE PHARMA LIMITED H. LUNDBECK A/S

SE/H/0279/002

277 342-7

H. LUNDBECK A/S

List of nationally authorised medicinal products EMA/590630/2017

Member State where product is authorised

PT

PT

PT

PT

PT

PT

UK UK UK FR FR

Page 4/28

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

mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 10 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 5 mg, comprimé pelliculé ESCITALOPRAM ZENTIVA LAB 5 mg, comprimé pelliculé ESCITALOPRAM ZENTIVA LAB 5 mg, comprimé pelliculé ESCITALOPRAM ZENTIVA LAB 5 mg, comprimé pelliculé ESCITALOPRAM ZENTIVA LAB 15 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 15 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 15 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 20 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 20 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 20 mg, comprimé pelliculé sécable ESCITALOPRAM ZENTIVA LAB 20 mg/ml, solution buvable en gouttes Escitalopram Lundbeck 5 mg tabletti, kalvopäällysteinen Escitalopram Lundbeck 10 mg tabletti, kalvopäällysteinen Escitalopram Lundbeck 15 mg tabletti, kalvopäällysteinen Escitalopram Lundbeck 20 mg tabletti, kalvopäällysteinen

List of nationally authorised medicinal products EMA/590630/2017

SE/H/0279/002

277 343-3

H. LUNDBECK A/S

FR

SE/H/0279/001

277 336-7

H. LUNDBECK A/S

FR

SE/H/0279/001

277 337-3

H. LUNDBECK A/S

FR

SE/H/0279/001

277 339-6

H. LUNDBECK A/S

FR

SE/H/0279/001

277 340-4

H. LUNDBECK A/S

FR

SE/H/0279/003

277 345-6

H. LUNDBECK A/S

FR

SE/H/0279/003

277 346-2

H. LUNDBECK A/S

FR

SE/H/0279/003

277 347-9

H. LUNDBECK A/S

FR

SE/H/0279/004

277 348-5

H. LUNDBECK A/S

FR

SE/H/0279/004

277 349-1

H. LUNDBECK A/S

FR

SE/H/0279/004

277 351-6

H. LUNDBECK A/S

FR

SE/H/0279/006

277 333-8

H. LUNDBECK A/S

FR

SE/H/0279/001

31841

H. LUNDBECK A/S

FI

SE/H/0279/002

31842

H. LUNDBECK A/S

FI

SE/H/0279/003

31843

H. LUNDBECK A/S

FI

SE/H/0279/004

31844

H. LUNDBECK A/S

FI

Page 5/28

Product Name (in authorisation country) Escitalopram Lundbeck 10 mg Filmtabletten Escitalopram Lundbeck 20 mg Filmtabletten Escitalopram Lundbeck 20 mg/ml Tropfen zum Einnehmen, Lösung Entact 20 mg/ml gocce orali, soluzione Escitalopram Lundbeck 20 mg/ml orala droppar, lösning Escitalopram Lundbeck 5 mg, filmdragerade tabletter Escitalopram Lundbeck 10 mg, filmdragerade tabletter Escitalopram Lundbeck 15 mg, filmdragerade tabletter Escitalopram Lundbeck 20 mg, filmdragerade tabletter Escitalopram Lundbeck 10 mg munsönderfallande tabletter Escitalopram Lundbeck 20 mg munsönderfallande tabletter Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0279/002

90990.00.00

H. LUNDBECK A/S

DE

SE/H/0279/004

90991.00.00

H. LUNDBECK A/S

DE

SE/H/0279/006

90992.00.00

H. LUNDBECK A/S

DE

SE/H/0280/006

035768656

H. LUNDBECK A/S

IT

SE/H/0279/006

23324

H. LUNDBECK A/S

SE

SE/H/0279/001

17088

H. LUNDBECK A/S

SE

SE/H/0279/002

17089

H. LUNDBECK A/S

SE

SE/H/0279/003

17090

H. LUNDBECK A/S

SE

SE/H/0279/004

17091

H. LUNDBECK A/S

SE

SE/H/0279/008

42058

H. LUNDBECK A/S

SE

SE/H/0279/009

42059

H. LUNDBECK A/S

SE

SE/H/0280/001

035768011

H. LUNDBECK A/S

IT

SE/H/0280/001

035768023

H. LUNDBECK A/S

IT

SE/H/0280/001

035768035

H. LUNDBECK A/S

IT

SE/H/0280/001

035768047

H. LUNDBECK A/S

IT

SE/H/0280/001

035768492

H. LUNDBECK A/S

IT

SE/H/0280/001

035768504

H. LUNDBECK A/S

IT

Page 6/28

Product Name (in authorisation country) Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 5 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film Entact 10 mg compresse rivestite con film

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0280/001

035768516

H. LUNDBECK A/S

IT

SE/H/0280/001

035768175

H. LUNDBECK A/S

IT

SE/H/0280/001

035768187

H. LUNDBECK A/S

IT

SE/H/0280/001

035768199

H. LUNDBECK A/S

IT

SE/H/0280/001

035768201

H. LUNDBECK A/S

IT

SE/H/0280/001

035768213

H. LUNDBECK A/S

IT

SE/H/0280/001

035768225

H. LUNDBECK A/S

IT

SE/H/0280/001

035768415

H. LUNDBECK A/S

IT

SE/H/0280/001

035768427

H. LUNDBECK A/S

IT

SE/H/0280/002

035768050

H. LUNDBECK A/S

IT

SE/H/0280/002

035768062

H. LUNDBECK A/S

IT

SE/H/0280/002

035768074

H. LUNDBECK A/S

IT

SE/H/0280/002

035768086

H. LUNDBECK A/S

IT

SE/H/0280/002

035768528

H. LUNDBECK A/S

IT

SE/H/0280/002

035768542

H. LUNDBECK A/S

IT

SE/H/0280/002

035768237

H. LUNDBECK A/S

IT

SE/H/0280/002

035768249

H. LUNDBECK A/S

IT

Page 7/28

Product Name (in authorisation country) Entact 10 con film Entact 10 con film Entact 10 con film Entact 10 con film Entact 10 con film Entact 10 con film Entact 10 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

mg compresse rivestite

SE/H/0280/002

035768252

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768264

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768276

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768288

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768439

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768441

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/002

035768530

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768098

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768100

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768112

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768555

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768567

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768579

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768290

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768302

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768314

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768326

H. LUNDBECK A/S

IT

List of nationally authorised medicinal products EMA/590630/2017

Page 8/28

Product Name (in authorisation country) Entact 15 con film Entact 15 con film Entact 15 con film Entact 15 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film Entact 20 con film

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

mg compresse rivestite

SE/H/0280/003

035768340

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768338

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768454

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/003

035768124

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768148

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768151

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768136

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768163

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768581

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768593

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768605

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768353

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768365

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768377

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768389

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768391

H. LUNDBECK A/S

IT

mg compresse rivestite

SE/H/0280/004

035768403

H. LUNDBECK A/S

IT

List of nationally authorised medicinal products EMA/590630/2017

Page 9/28

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

Entact 20 mg compresse rivestite con film Cipralex 10 mg filmom obložene tablete Cipralex 10 mg filmtabletta

SE/H/0280/004

035768478

H. LUNDBECK A/S

IT

SE/H/0280/002

UP/I-530-09/13-02/247

HR

SE/H/0278/002

OGYI-T-8634/01

LUNDBECK CROATIA D.O.O. H. LUNDBECK A/S

Cipralex MELTZ 10 mg szájban diszpergálódó tabletta Cipralex MELTZ 20 mg szájban diszpergálódó tabletta Cipralex 10 mg filmom obalené tablety Lexapro 15 mg film-coated tablets Lexapro 5 mg film-coated tablets

SE/H/0278/008

OGYI-T-8634/05

H. LUNDBECK A/S

HU

SE/H/0278/009

OGYI-T-8634/06

H. LUNDBECK A/S

HU

SE/H/278/02

30/0210/07-S

H. LUNDBECK A/S

SK

SE/H/0278/003

PA 805/2/3

H. LUNDBECK A/S

IE

SE/H/0278/001

PA 805/2/1

H. LUNDBECK A/S

IE

Lexapro 10 mg film-coated tablets Lexapro 20 mg film-coated tablets SEROPLEX 5 mg, comprimé pelliculé SEROPLEX 5 mg, comprimé pelliculé SEROPLEX 5 mg, comprimé pelliculé SEROPLEX 5 mg, comprimé pelliculé SEROPLEX 5 mg, comprimé pelliculé SEROPLEX 10 mg, comprimé pelliculé sécable SEROPLEX 10 mg, comprimé pelliculé sécable SEROPLEX 10 mg, comprimé pelliculé sécable

SE/H/0278/002

PA 805/2/2

H. LUNDBECK A/S

IE

SE/H/0278/004

PA 805/2/4

H. LUNDBECK A/S

IE

SE/H/0278/001

364 289-7

H. LUNDBECK A/S

FR

SE/H/0278/001

359 935-1

H. LUNDBECK A/S

FR

SE/H/0278/001

359 936-8

H. LUNDBECK A/S

FR

SE/H/0278/001

570 950-7

H. LUNDBECK A/S

FR

SE/H/0278/001

563 706-7

H. LUNDBECK A/S

FR

SE/H/0278/002

359 937-4

H. LUNDBECK A/S

FR

SE/H/0278/002

359 938-0

H. LUNDBECK A/S

FR

SE/H/0278/002

570 951-3

H. LUNDBECK A/S

FR

List of nationally authorised medicinal products EMA/590630/2017

HU

Page 10/28

Product Name (in authorisation country) SEROPLEX 10 mg, comprimé pelliculé sécable SEROPLEX 15 mg, comprimé pelliculé sécable SEROPLEX 15 mg, comprimé pelliculé sécable SEROPLEX 15 mg, comprimé pelliculé sécable SEROPLEX 15 mg, comprimé pelliculé sécable SEROPLEX 20 mg, comprimé pelliculé sécable SEROPLEX 20 mg, comprimé pelliculé sécable SEROPLEX 20 mg, comprimé pelliculé sécable SEROPLEX 20 mg, comprimé pelliculé sécable SEROPLEX 20 mg/ml, solution buvable en gouttes Cipralex 20 mg/ml Gotas orales en solución CIPRALEX 5 mg, comprimidos recubiertos con película CIPRALEX 10 mg, comprimidos recubiertos con película CIPRALEX 15 mg, comprimidos recubiertos con película CIPRALEX 20 mg, comprimidos recubiertos con película Cipralex 5 mg comprimidos revestidos por película Cipralex 5 mg comprimidos revestidos por película

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/002

563 707-3

H. LUNDBECK A/S

FR

SE/H/0278/003

359 939-7

H. LUNDBECK A/S

FR

SE/H/0278/003

359 940-5

H. LUNDBECK A/S

FR

SE/H/0278/003

570 953-6

H. LUNDBECK A/S

FR

SE/H/0278/003

563 709-6

H. LUNDBECK A/S

FR

SE/H/0278/004

359 941-1

H. LUNDBECK A/S

FR

SE/H/0278/004

359 942-8

H. LUNDBECK A/S

FR

SE/H/0278/004

570 954-2

H. LUNDBECK A/S

FR

SE/H/0278/004

563 710-4

H. LUNDBECK A/S

FR

SE/H/0278/006

382 045-9

H. LUNDBECK A/S

FR

SE/H/0278/006

68811

ES

SE/H/0278/001

65.231

SE/H/0278/002

65.230

SE/H/0278/003

65.234

SE/H/0278/004

65.233

SE/H/0278/001

4301081

LUNDBECK ESPANA, ES LUNDBECK ESPANA, ES LUNDBECK ESPANA, ES LUNDBECK ESPANA, ES LUNDBECK ESPANA, ES H. LUNDBECK A/S

SE/H/0278/001

4301180

H. LUNDBECK A/S

PT

ES ES ES ES PT

Page 11/28

Product Name (in authorisation country) Cipralex 5 mg comprimidos revestidos por película Cipralex 5 mg comprimidos revestidos por película Cipralex 5 mg comprimidos revestidos por película Cipralex 5 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 10 mg comprimidos revestidos por película Cipralex 15 mg comprimidos revestidos por película Cipralex 15 mg comprimidos revestidos por película Cipralex 15 mg comprimidos revestidos por película Cipralex 15 mg comprimidos revestidos por película Cipralex 15 mg comprimidos revestidos por película

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/001

4301784

H. LUNDBECK A/S

PT

SE/H/0278/001

4301883

H. LUNDBECK A/S

PT

SE/H/0278/001

4301982

H. LUNDBECK A/S

PT

SE/H/0278/001

4302089

H. LUNDBECK A/S

PT

SE/H/0278/002

4304085

H. LUNDBECK A/S

PT

SE/H/0278/002

4304184

H. LUNDBECK A/S

PT

SE/H/0278/002

5026315

H. LUNDBECK A/S

PT

SE/H/0278/002

4304788

H. LUNDBECK A/S

PT

SE/H/0278/002

4304887

H. LUNDBECK A/S

PT

SE/H/0278/002

4304986

H. LUNDBECK A/S

PT

SE/H/0278/002

4305082

H. LUNDBECK A/S

PT

SE/H/0278/002

5013958

H. LUNDBECK A/S

PT

SE/H/0278/003

4307187

H. LUNDBECK A/S

PT

SE/H/0278/003

4307286

H. LUNDBECK A/S

PT

SE/H/0278/003

4307880

H. LUNDBECK A/S

PT

SE/H/0278/003

4307989

H. LUNDBECK A/S

PT

SE/H/0278/003

4308086

H. LUNDBECK A/S

PT

Page 12/28

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

Cipralex 15 mg comprimidos revestidos por película Cipralex 20 mg comprimidos revestidos por película Cipralex 20 mg comprimidos revestidos por película Cipralex 20 mg comprimidos revestidos por película Cipralex 20 mg comprimidos revestidos por película Cipralex 20 mg comprimidos revestidos por película CIPRALEX 20 mg/ml Gotas orais, solução CIPRALEX 10 mg potahované tablety CIPRALEX Orotab 10 mg tablety dispergovatelné v ústech CIPRALEX Orotab 20 mg tablety dispergovatelné v ústech CIPRALEX 20 mg/ml perorální kapky, roztok Cipralex® 5 mg – Filmtabletten

SE/H/0278/003

4308185

H. LUNDBECK A/S

PT

SE/H/0278/004

4302683

H. LUNDBECK A/S

PT

SE/H/0278/004

5074711

H. LUNDBECK A/S

PT

SE/H/0278/004

4303384

H. LUNDBECK A/S

PT

SE/H/0278/004

4303483

H. LUNDBECK A/S

PT

SE/H/0278/004

4303582

H. LUNDBECK A/S

PT

SE/H/0278/006

5049739

H. LUNDBECK A/S

PT

SE/H/0278/002

30/276/02-C

H. LUNDBECK A/S

CZ

SE/H/0278/008

30/486/10-C

H. LUNDBECK A/S

CZ

SE/H/0278/009

30/487/10-C

H. LUNDBECK A/S

CZ

SE/H/0278/006

30/494/07-C

H. LUNDBECK A/S

CZ

SE/H/0278/001

1-24549

H. LUNDBECK A/S

AT

Cipralex® 10 mg – Filmtabletten

SE/H/0278/002

1-24550

H. LUNDBECK A/S

AT

Cipralex® 15 mg – Filmtabletten

SE/H/0278/003

1-24551

H. LUNDBECK A/S

AT

Cipralex® 20 mg – Filmtabletten

SE/H/0278/004

1-24552

H. LUNDBECK A/S

AT

Cipralex

SE/H/0278/001

33407

H. LUNDBECK A/S

DK

Cipralex

SE/H/0278/002

33408

H. LUNDBECK A/S

DK

Cipralex

SE/H/0278/003

33409

H. LUNDBECK A/S

DK

Cipralex

SE/H/278/04

33411

H. LUNDBECK A/S

DK

Cipralex Meltz

SE/H/0278/008

44624

H. LUNDBECK A/S

DK

List of nationally authorised medicinal products EMA/590630/2017

Page 13/28

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

Cipralex Meltz

SE/H/0278/009

44625

H. LUNDBECK A/S

DK

Cipralex

SE/H/0278/006

41275

H. LUNDBECK A/S

DK

CIPRALEX 5 mg filmdrasjerte tabletter CIPRALEX 10 mg filmdrasjerte tabletter CIPRALEX 15 mg filmdrasjerte tabletter CIPRALEX 20 mg filmdrasjerte tabletter Cipralex 20 mg/ml dråper, oppløsning CIPRALEX® 5 mg film-coated tablets CIPRALEX® 10 mg film-coated tablets CIPRALEX® 20 mg film-coated tablets CIPRALEX 20 mg/ml oral drops, solution CIPRALEX® 10 mg Filmtabletten

SE/H/0278/001

02-712

H. LUNDBECK A/S

NO

SE/H/0278/002

02-713

H. LUNDBECK A/S

NO

SE/H/0278/003

02-714

H. LUNDBECK A/S

NO

SE/H/0278/004

02-715

H. LUNDBECK A/S

NO

SE/H/0278/006

07-4892

H. LUNDBECK A/S

NO

SE/H/0278/001

PL 13761/0008

H. LUNDBECK A/S

UK

SE/H/0278/002

PL 13761/0009

H. LUNDBECK A/S

UK

SE/H/0278/004

PL 13761/0011

H. LUNDBECK A/S

UK

SE/H/0278/006

PL 13761/0028

H. LUNDBECK A/S

UK

SE/H/0278/002

55880.01.00

H. LUNDBECK A/S

DE

CIPRALEX® 20 mg Filmtabletten

SE/H/0278/004

55880.03.00

H. LUNDBECK A/S

DE

Cipralex® 20 mg/ml Tropfen zum Einnehmen, Lösung Cipralex 10 mg apvalkotās tabletes Cipralex 20 mg apvalkotās tabletes Sipralexa 5 mg filmomhulde tabletten Sipralexa 10 mg filmomhulde tabletten Sipralexa 15 mg filmomhulde

SE/H/0278/006

69241.00.00

H. LUNDBECK A/S

DE

SE/H/0278/002

07 – 0298

H. LUNDBECK A/S

LV

SE/H/0278/004

07-0300

H. LUNDBECK A/S

LV

SE/H/0278/001

BE238962

H. LUNDBECK A/S

BE

SE/H/0278/002

BE238971

H. LUNDBECK A/S

BE

SE/H/0278/003

BE238944

H. LUNDBECK A/S

BE

List of nationally authorised medicinal products EMA/590630/2017

Page 14/28

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

tabletten SIPRALEXA 20 mg, filmomhulde tabletten SIPRALEXA 5 mg, comprimés pelliculés. SIPRALEXA 10 mg, comprimés pelliculés SIPRALEXA 15 mg, comprimés pelliculés SIPRALEXA 20 mg, comprimés pelliculés CIPRALEX 5 mg film-coated tablets CIPRALEX® 10 mg film-coated tablets CIPRALEX 15 mg film-coated tablets CIPRALEX 20 mg film-coated tablets Sipralexa 5 mg comprimés pelliculés Sipralexa 10 mg comprimés pelliculés Sipralexa 15 mg comprimés pelliculés Sipralexa 20 mg comprimés pelliculés Cipralex, 10 mg õhukese polümeerikattega tabletid Cipralex, 20 mg õhukese polümeerikattega tabletid CIPRALEX 5 mg filmuhúðaðar töflur CIPRALEX 10 mg filmuhúðaðar

List of nationally authorised medicinal products EMA/590630/2017

SE/H/0278/004

BE238953

H. LUNDBECK A/S

BE

SE/H/0278/001

BE 238962

H. LUNDBECK A/S

BE

SE/H/0278/002

BE 238971

H. LUNDBECK A/S

BE

SE/H/0278/003

BE 238944

H. LUNDBECK A/S

BE

SE/H/0278/004

BE 238953

H. LUNDBECK A/S

BE

SE/H/0278/001

MA591/00201

H. LUNDBECK A/S

MT

SE/H/0278/002

MA601/00302

H. LUNDBECK A/S

MT

SE/H/0278/003

MA601/00303

H. LUNDBECK A/S

MT

SE/H/0278/004

MA601/00304

H. LUNDBECK A/S

MT

SE/H/0278/001

BE238962

H. LUNDBECK A/S

LU

SE/H/0278/002

BE238971

H. LUNDBECK A/S

LU

SE/H/0278/003

BE238944

H. LUNDBECK A/S

LU

SE/H/0278/004

BE238953

H. LUNDBECK A/S

LU

SE/H/0278/002

392502

H. LUNDBECK A/S

EE

SE/H/0278/004

392702

H. LUNDBECK A/S

EE

SE/H/0278/001

IS/1/02/019/01

H. LUNDBECK A/S

IS

SE/H/0278/002

IS/1/02/019/02

H. LUNDBECK A/S

IS

Page 15/28

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

töflur CIPRALEX 15 mg filmuhúðaðar töflur CIPRALEX 20 mg filmuhúðaðar töflur CIPRALEX 5 mg, filmdragerade tabletter CIPRALEX 10 mg, filmdragerade tabletter CIPRALEX 15 mg, filmdragerade tabletter CIPRALEX 20 mg, filmdragerade tabletter PRILECT 5 mg, filmdragerade tabletter PRILECT 10 mg, filmdragerade tabletter PRILECT 15 mg, filmdragerade tabletter PRILECT 20 mg, filmdragerade tabletter Prilect 10 mg munsönderfallande tabletter Prilect 20 mg munsönderfallande tabletter Cipralex 10 mg munsönderfallande tabletter Cipralex 20 mg munsönderfallande tabletter CIPRALEX 20 mg/ml orala droppar, lösning PRILECT 20 mg/ml orala droppar, lösning LEXAPRO 20 mg/ml druppels

List of nationally authorised medicinal products EMA/590630/2017

SE/H/0278/003

IS/1/02/019/03

H. LUNDBECK A/S

IS

SE/H/0278/004

IS/1/02/019/04

H. LUNDBECK A/S

IS

SE/H/0278/001

17084

H. LUNDBECK A/S

SE

SE/H/0278/002

17085

H. LUNDBECK A/S

SE

SE/H/0278/003

17086

H. LUNDBECK A/S

SE

SE/H/0278/004

17087

H. LUNDBECK A/S

SE

SE/H/0280/001

17096

H. LUNDBECK A/S

SE

SE/H/0280/002

17097

H. LUNDBECK A/S

SE

SE/H/0280/003

17098

H. LUNDBECK A/S

SE

SE/H/0280/004

17099

H. LUNDBECK A/S

SE

SE/H/0280/008

42055

H. LUNDBECK A/S

SE

SE/H/0280/009

42056

H. LUNDBECK A/S

SE

SE/H/0278/008

42055

H. LUNDBECK A/S

SE

SE/H/0278/009

42056

H. LUNDBECK A/S

SE

SE/H/0278/006

23323

H. LUNDBECK A/S

SE

SE/H/0280/006

23323

H. LUNDBECK A/S

SE

SE/H/0279/006

RVG 35339

H. LUNDBECK A/S

NL

Page 16/28

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

voor oraal gebruik, oplossing LEXAPRO 5 mg filmomhulde tabletten LEXAPRO 10 mg filmomhulde tabletten LEXAPRO 15 mg filmomhulde tabletten LEXAPRO 20 mg filmomhulde tabletten Cipralex 5 mg tabletti, kalvopäällysteinen Cipralex 10 mg tabletti, kalvopäällysteinen Cipralex 15 mg tabletti, kalvopäällysteinen Cipralex 20 mg tabletti, kalvopäällysteinen Cipralex 10 mg tabletti, suussa hajoava Cipralex 20 mg tabletti, suussa hajoava Cipralex 20 mg/ml tipat, liuos

SE/H/0279/001

RVG 30494

H. LUNDBECK A/S

NL

SE/H/0279/002

RVG 30495

H. LUNDBECK A/S

NL

SE/H/0279/003

RVG 30496

H. LUNDBECK A/S

NL

SE/H/0279/004

RVG 30497

H. LUNDBECK A/S

NL

SE/H/0278/001

17690

H. LUNDBECK A/S

FI

SE/H/0278/002

17691

H. LUNDBECK A/S

FI

SE/H/0278/003

17692

H. LUNDBECK A/S

FI

SE/H/0278/004

17693

H. LUNDBECK A/S

FI

SE/H/0278/008

27218

H. LUNDBECK A/S

FI

SE/H/0278/009

27219

H. LUNDBECK A/S

FI

SE/H/0278/006

23395

H. LUNDBECK A/S

FI

Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/017

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/018

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/019

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/020

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/021

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/022

H. LUNDBECK A/S

LT

List of nationally authorised medicinal products EMA/590630/2017

Page 17/28

Product Name (in authorisation country) Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/023

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/024

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/025

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/026

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/027

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/028

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/029

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/030

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/031

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/032

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/066

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/069

H. LUNDBECK A/S

LT

10 mg plevele dengtos

SE/H/0278/002

LT/1/07/0832/070

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/049

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/050

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/051

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/052

H. LUNDBECK A/S

LT

List of nationally authorised medicinal products EMA/590630/2017

Page 18/28

Product Name (in authorisation country) Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex tabletes Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/053

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/054

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/055

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/056

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/057

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/058

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/059

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/060

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/061

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/062

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/063

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/064

H. LUNDBECK A/S

LT

20 mg plevele dengtos

SE/H/278/04

LT/1/07/0832/072

H. LUNDBECK A/S

LT

5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film

SE/H/0278/001

035767019/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767021/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767033/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767045/M

H. LUNDBECK A/S

IT

List of nationally authorised medicinal products EMA/590630/2017

Page 19/28

Product Name (in authorisation country) Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite

5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 5 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/001

035767603/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767490/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767502/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767173/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767185/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767197/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767209/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767211/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767223/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767413/M

H. LUNDBECK A/S

IT

SE/H/0278/001

035767425/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767058/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767060/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767072/M

H. LUNDBECK A/S

IT

SE/H/278/02

035767084/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767514/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767526/M

H. LUNDBECK A/S

IT

Page 20/28

Product Name (in authorisation country) Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite

10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 10 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/002

035767538/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767235/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767247/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767250/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767262/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767274/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767286/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767437/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767449/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767096/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767108/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767110/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767122/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767540/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767553/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767565/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767298/M

H. LUNDBECK A/S

IT

Page 21/28

Product Name (in authorisation country) Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite Cipralex rivestite

15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 15 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film 20 mg compresse con film

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/003

035767300/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767312/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767324/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767336/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767348/M

H. LUNDBECK A/S

IT

SE/H/0278/003

035767452/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767134/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767146/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767159/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767161/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767577/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767589/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767591/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767351/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767363/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767375/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767387/M

H. LUNDBECK A/S

IT

Page 22/28

Product Name (in authorisation country) Cipralex 20 mg compresse rivestite con film Cipralex 20 mg compresse rivestite con film Cipralex 20 mg compresse rivestite con film Cipralex 10 mg/ml gocce orali, soluzione Cipralex 10 mg/ml gocce orali, soluzione Cipralex 10 mg/ml gocce orali, soluzione Cipralex 10 mg/ml gocce orali, soluzione Cipralex MELTZ 10 mg comprimate orodispersabile Cipralex MELTZ 20 mg comprimate orodispersabile CIPRALEX 5 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 10 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 15 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 20 mg επικαλυμμένα με λεπτό υμένιο δισκία ENTACT 5 mg επικαλυμμένα με λεπτό υμένιο δισκία ENTACT 10 mg επικαλυμμένα με λεπτό υμένιο δισκία ENTACT 15 mg επικαλυμμένα με λεπτό υμένιο δισκία ENTACT 20 mg επικαλυμμένα με λεπτό υμένιο δισκία

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/004

035767399/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767401/M

H. LUNDBECK A/S

IT

SE/H/0278/004

035767464/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767615/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767627/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767639/M

H. LUNDBECK A/S

IT

SE/H/0278/002

035767641/M

H. LUNDBECK A/S

IT

SE/H/0278/008

2602/2010/01-03

H. LUNDBECK A/S

RO

SE/H/0278/009

2603/2010/01-03

H. LUNDBECK A/S

RO

SE/H/0278/001

76959

H. LUNDBECK A/S

GR

SE/H/0278/002

76961

H. LUNDBECK A/S

GR

SE/H/0278/003

76963

H. LUNDBECK A/S

GR

SE/H/0278/004

76964

H. LUNDBECK A/S

GR

SE/H/0279/001

76950/26-11-07

H. LUNDBECK A/S

GR

SE/H/0279/002

76953/26-11-07

H. LUNDBECK A/S

GR

SE/H/0279/003

76954/26-11-07

H. LUNDBECK A/S

GR

SE/H/0279/004

76955/26-11-07

H. LUNDBECK A/S

GR

Page 23/28

Product Name (in authorisation country) CIPRALEX 10 mg/ml πόσιμες σταγόνες, διάλυμα CIPRALEX 5 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 10 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 15 mg επικαλυμμένα με λεπτό υμένιο δισκία CIPRALEX 20 mg επικαλυμμένα με λεπτό υμένιο δισκία Cipralex 20 mg/ml gocce orali, soluzione Premalex 10 mg, filmdragerade tabletter Premalex 20 mg, filmdragerade tabletter Cipralex 10 mg filmsko obložene tablete Lexapro, 5 mg, tabletki powlekane Lexapro, 10 mg, tabletki powlekane ЦИПРАЛЕКС MЕЛЦ 10 mg таблетки, диспергиращи се в устата ЦИПРАЛЕКС MЕЛЦ 20 mg таблетки, диспергиращи се в устата ЦИПРАЛЕКС 10 mg филмирани таблетки CIPRALEX 10 mg comprimate filmate Zocital 5 mg comprimidos revestidos por película

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SE/H/0278/005

76965

H. LUNDBECK A/S

GR

SE/H/0278/001

20266

H. LUNDBECK A/S

CY

SE/H/0278/002

20267

H. LUNDBECK A/S

CY

SE/H/0278/003

20268

H. LUNDBECK A/S

CY

SE/H/0278/004

20269

H. LUNDBECK A/S

CY

SE/H/0278/006

035767654/M

H. LUNDBECK A/S

IT

not available

42255

SE

not available

42256

SE/H/0278/002

5363-I-689/07

SE/H/0278/001

14282

H. LUNDBECK AB, SE H. LUNDBECK AB, SE LUNDBECK PHARMA D.O.O H. LUNDBECK A/S

SE/H/0278/002

14283

H. LUNDBECK A/S

PL

SE/H/0278/008

20100096

H. LUNDBECK A/S

BG

SE/H/0278/009

20100097

H. LUNDBECK A/S

BG

SE/H/0278/002

20020663

H. LUNDBECK A/S

BG

SE/H/0278/002

9256/2016/01-19

H. LUNDBECK A/S

RO

not available

5122437

GENEDEC MEDICAMENTOS GENÉRICOS, LDA.

PT

SE SI PL

Page 24/28

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

Zocital 5 mg comprimidos revestidos por película

not available

5122445

Zocital 10 mg comprimidos revestidos por película

not available

5122460

Zocital 10 mg comprimidos revestidos por película

not available

5122478

Zocital 15 mg comprimidos revestidos por película

not available

5122510

Zocital 15 mg comprimidos revestidos por película

not available

5122528

Zocital 20 mg comprimidos revestidos por película

not available

5122544

Zocital 20 mg comprimidos revestidos por película

not available

5122551

Zocital 5 mg comprimidos revestidos por película

not available

5122429

Zocital 10 mg comprimidos revestidos por película

not available

5122452

Zocital 15 mg comprimidos revestidos por película

not available

5122502

Zocital 20 mg comprimidos revestidos por película

not available

5122536

Escitalopram-neuraxpharm 10 mg Schmelztabletten

DE/H/5050/002

88039.00.00

List of nationally authorised medicinal products EMA/590630/2017

MAH of product in the member state GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. GENEDEC MEDICAMENTOS GENÉRICOS, LDA. NEURAXPHARM ARZNEIMITTEL

Member State where product is authorised PT PT PT PT PT PT PT PT PT PT PT DE

Page 25/28

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

GMBH Escitalopram-neuraxpharm 20 mg Schmelztabletten

DE/H/5050/004

88041.00.00

Zecidec 5 mg comprimidos revestidos por película

not available

5122577

Zecidec 5 mg comprimidos revestidos por película

not available

5122601

Zecidec 10 mg comprimidos revestidos por película

not available

5122627

Zecidec 10 mg comprimidos revestidos por película

not available

5122635

Zecidec 15 mg comprimidos revestidos por película

not available

5122650

Zecidec 15 mg comprimidos revestidos por película

not available

5122668

Zecidec 20 mg comprimidos revestidos por película

not available

5122700

Zecidec 20 mg comprimidos revestidos por película

not available

5122718

Zecidec 5 mg comprimidos revestidos por película

not available

5122569

Zecidec 10 mg comprimidos revestidos por película

not available

5122619

List of nationally authorised medicinal products EMA/590630/2017

NEURAXPHARM ARZNEIMITTEL GMBH DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A.

DE PT PT PT PT PT PT PT PT PT PT

Page 26/28

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

Zecidec 15 mg comprimidos revestidos por película

not available

5122643

Zecidec 20 mg comprimidos revestidos por película

not available

5122676

ENLIFT 10 mg επικαλυμμένα με λεπτό υμένιο δισκία ENLIFT 20 mg επικαλυμμένα με λεπτό υμένιο δισκία Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets

EE/H/0181/002

34924/17-5-13

EE/H/0181/004

37662/17-5-13

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

List of nationally authorised medicinal products EMA/590630/2017

MAH of product in the member state DECOMED FARMACÊUTICA, S.A. DECOMED FARMACÊUTICA, S.A. MEDOCHEMIE HELLAS SA MEDOCHEMIE HELLAS SA BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED

Member State where product is authorised PT PT GR GR UK UK UK UK UK UK UK UK UK UK UK UK

Page 27/28

Product Name (in authorisation country) Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram 15 mg Film-Coated Tablets Escitalopram Teva 15 mg filmsko oblozene tablete Escitalopram Teva 20 mg filmsko oblozene tablete Escitalopram-ratiopharm® 5 mg Filmtabletten Escitalopram-ratiopharm® 15 mg Filmtabletten

List of nationally authorised medicinal products EMA/590630/2017

MRP/DCP Authorisation number

National Authorisation Number

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

UK/H/6523/003

PL 25298/0110

HU/H/0179/003

MAH of product in the member state

Member State where product is authorised UK

H/09/00573/045

BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED BROWN & BURK UK LIMITED TEVA PHARMA B.V.

HU/H/0179/004

H/09/00573/066

TEVA PHARMA B.V.

SI

HU/H/0179/001

2012110001

LU

HU/H/0179/003

2012100113

RATIOPHARM GMBH RATIOPHARM GMBH

UK UK UK SI

LU

Page 28/28