Methotrexate - Art 31PhV - List of products Rev 1 · 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000Facsimile

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

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

12 April 2018 EMA/204541/2018 Rev 1 Human Medicines Evaluation Division

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for methotrexate containing medicinal products

Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data

Procedure number: EMEA/H/A-31/1463

Jylamvo EMEA/H/A-31/1463/C/3756/0002

Nordimet EMEA/H/A-31/1463/C/3983/0006

http://www.ema.europa.eu/contact

Annex I EMA/204541/2018 Page 2/159

Nationally authorised medicinal products

Member State in EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical dose form

Route of Administration

Austria Accord Healthcare Limited Methofill Methotrexate 0.15ml/7.5mg

Solution For Injection In Pre-Filled Syringe

Subcutaneous Use



Subcutaneous Use

Austria Accord Healthcare Limited Methofill Methotrexate 0.2ml/10mg


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 3/159

Member State in EEA




Austria Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml

Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use






Concentrate For Solution For Infusion

Intraarterial Use | Intramuscular Use | Intravenous Use







Austria Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml

Solution For Injection Subcutaneous Use

Austria Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml






Annex I EMA/204541/2018 Page 4/159

Member State in EEA


















Austria Ebewe Pharma Ebetrexat Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Austria Ebewe Pharma Ebetrexat Methotrexate 10mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Subcutaneous Use

Austria Ebewe Pharma Ebetrexat Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Annex I EMA/204541/2018 Page 5/159

Member State in EEA




Austria Ebewe Pharma Ebetrexat Methotrexate Disodium 10.97mg/Ml

Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Austria Ebewe Pharma Ebetrexat Methotrexate 10mg Tablet

Tablet Oral Use

Austria Ebewe Pharma Ebetrexat Methotrexate 2.5mg Tablet

Tablet Oral Use

Austria Ebewe Pharma Ebetrexat Methotrexate 5mg Tablet

Tablet Oral Use

Austria Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Austria Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Metoject Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Syringe

Intramuscular Use | Intravenous Use | Subcutaneous Use


Metoject Pen Methotrexate 10mg/0.2ml

Solution For Injection In Pre-Filled Pen

Subcutaneous Use


Metoject Pen Methotrexate 12.5mg/0.25ml


Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 6/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Austria Pfizer Corporation Austria Gesellschaft M.B.H.

Methotrexat "lederle"

Methotrexate Disodium 27.41mg Vial

Solution For Injection/Infusion

Intramuscular Use | Intrathecal Use | Intravenous Use

Annex I EMA/204541/2018 Page 7/159

Member State in EEA




Austria Pfizer Corporation Austria Gesellschaft M.B.H.

Methotrexat "lederle"

Methotrexate Disodium 2.74mg Tablet

Tablet Oral Use

Belgium Accord Healthcare Limited Methotrexate Accord Healthcare

Methotrexate 1000mg/40ml




















Belgium Addenda Pharma S.R.L. Methotrexate Addenda

Methotrexate 10mg/0.4ml


Subcutaneous Use


Methotrexate 12.5mg/0.31ml


Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 8/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Belgium Aurobindo Pharma B.V. Methotrexaat Ab Methotrexate 25mg/Ml Solution For Injection/Infusion


Belgium Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Metoject Methotrexate 12.5mg/0.25ml



Annex I EMA/204541/2018 Page 9/159

Member State in EEA
















Metoject Methotrexate 10mg/0.2ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 10/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Belgium Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 5.48mg

Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use

Belgium Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 8.23mg/Ml



Belgium Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 2.74mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 11/159

Member State in EEA




Belgium Pfizer S.A. (Belgium) Ledertrexate Concentrate

Methotrexate Disodium 1096.8mg

Concentrate For Solution For Injection

Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use

Belgium Pfizer S.A. (Belgium) Ledertrexate Concentrate




Belgium Sandoz N.V. Ebetrexat Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Belgium Sandoz N.V. Ebetrexat Methotrexate Disodium 21.94mg/Ml



Belgium Sandoz N.V. Methotrexate Sandoz

Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intravenous Use

Belgium Teva Pharma Belgium N.V./S.A

Emthexate Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use


Emthexate Methotrexate 5000mg/50ml





Annex I EMA/204541/2018 Page 12/159

Member State in EEA








Emthexate Methotrexate 5mg/2ml Solution For Injection Intraarticular Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Bulgaria Accord Healthcare Limited Инжексат Methotrexate 10mg/0.2ml


Subcutaneous Use

Bulgaria Accord Healthcare Limited Инжексат Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 13/159

Member State in EEA






Subcutaneous Use

Bulgaria Accord Healthcare Limited Инжексат Accord Methotrexate 15mg/0.3ml


Subcutaneous Use

Bulgaria Accord Healthcare Limited Метотрексат Акорд












Bulgaria Actavis Group Ptc Ehf. Намаксир Methotrexate 10mg/0.4ml

Solution For Injection Intravenous Use

Bulgaria Actavis Group Ptc Ehf. Намаксир Methotrexate 15mg/0.38ml


Bulgaria Actavis Group Ptc Ehf. Намаксир Methotrexate 2.5mg/0.33ml


Bulgaria Actavis Group Ptc Ehf. Намаксир Methotrexate 7.5mg/0.3ml


Bulgaria Ebewe Pharma Ebetrexat Methotrexate 10mg/Ml Solution For Injection Intravenous Use

Bulgaria Ebewe Pharma Ebetrexat Methotrexate 20mg/Ml Solution For Injection Intravenous Use

Bulgaria Ebewe Pharma Метотрексат Ебеве



Annex I EMA/204541/2018 Page 14/159

Member State in EEA





Methotrexate 10mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use | Subcutaneous Use


Methotrexate 10mg Tablet

Tablet Oral Use


Methotrexate 2.5mg Tablet

Tablet Oral Use



Tablet Oral Use

Bulgaria Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Meтожект Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Syringe



Метожект Pen Methotrexate 10mg/0.2ml


Subcutaneous Use


Метожект Pen Methotrexate 12.5mg/0.25ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 15/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Croatia Actavis Group Ptc Ehf. Namaxir Methotrexate 15mg/0.38ml


Intravenous Use



Subcutaneous Use

Croatia Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 16/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Croatia Cipla Europe Nv Metotreksat Cipla Methotrexate 10mg Tablet

Tablet Oral Use

Croatia Cipla Europe Nv Metotreksat Cipla Methotrexate 2.5mg Tablet

Tablet Oral Use

Croatia Medis Adria D.O.O. Metoject Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Syringe


Annex I EMA/204541/2018 Page 17/159

Member State in EEA




Croatia Pliva Hrvatska D.O.O. Metotreksat Pliva Methotrexate 50mg/2ml



Croatia Pliva Hrvatska D.O.O. Metotreksat Pliva Methotrexate 1000mg/10ml



Croatia Pliva Hrvatska D.O.O. Metotreksat Pliva Methotrexate 2.5mg/Ml Solution For Injection/Infusion

Intramuscular Use | Intravenous Use

Croatia Sandoz D.O.O. Ebetrexat Methotrexate 20mg/Ml Solution For Injection In Pre-Filled Syringe


Croatia Sandoz D.O.O. Metotreksat Sandoz


Tablet Oral Use

Cyprus Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml

Solution For Injection In A Pre-Filled Syringe.


Cyprus Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml









Annex I EMA/204541/2018 Page 18/159

Member State in EEA






















Cyprus Accord Healthcare Limited Methotrexate Accord






Annex I EMA/204541/2018 Page 19/159

Member State in EEA










Cyprus Pfizer Hellas, A.E. Methotrexate Pfizer Methotrexate 2.5mg Tablet

Tablet Oral Use

Cyprus Pharmaceutical Trading Co Ltd

Methotrexate Pharmaceutical Trading Co

Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Cyprus Remedica Ltd Methotrexate Remedica


Film-Coated Tablet Oral Use

Czech Republic Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Czech Republic Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 20/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml












Annex I EMA/204541/2018 Page 21/159

Member State in EEA







Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate Disodium 10.97mg/Ml



Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml



Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg Tablet

Tablet Oral Use

Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate 2.5mg Tablet

Tablet Oral Use

Czech Republic Ebewe Pharma Methotrexat Ebewe Methotrexate 5mg Tablet

Tablet Oral Use

Czech Republic Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use

Annex I EMA/204541/2018 Page 22/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 23/159

Member State in EEA







Subcutaneous Use

Czech Republic Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Czech Republic Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Czech Republic Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Czech Republic Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Denmark Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Denmark Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 24/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Denmark Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml















Annex I EMA/204541/2018 Page 25/159

Member State in EEA




Denmark Actavis Group Ptc Ehf. Namaxir Methotrexate 27.5mg/0.69ml


Denmark Actavis Group Ptc Ehf. Namaxir Methotrexate 30mg/0.75ml


Denmark Cipla Europe Nv Methotrexate Cipla Methotrexate 2.5mg Tablet

Tablet Oral Use

Denmark Ebewe Pharma Ebetrex Methotrexate Disodium 21.94mg/Ml


Denmark Ebewe Pharma Methotrexat ”ebewe”


Denmark Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Denmark Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg Tablet

Tablet Oral Use

Denmark Ebewe Pharma Methotrexat Ebewe Methotrexate 2.5mg Tablet

Tablet Oral Use

Denmark Ebewe Pharma Methotrexat Ebewe Methotrexate 5mg Tablet

Tablet Oral Use

Denmark Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Metex Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Syringe


Annex I EMA/204541/2018 Page 26/159

Member State in EEA





Metex Pen Methotrexate 10mg/0.2ml


Subcutaneous Use


Metex Pen Methotrexate 12.5mg/0.25ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 27/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Denmark Orion Corporation Methotrexate "orion"

Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe

Intramuscular Use | Subcutaneous Use

Denmark Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Denmark Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Denmark Pfizer Aps Methotrexate "pfizer"

Methotrexate 25mg/Ml Solution For Injection/Infusion


Denmark Pharmachemie B.V Emthexate Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intravenous Use

Denmark Pharmachemie B.V Emthexate Methotrexate 2.5mg Tablet

Tablet Oral Use

Denmark Sandoz A/S Methotrexat Sandoz


Tablet Oral Use

Estonia Accord Healthcare Limited Methotrexate Accord




Annex I EMA/204541/2018 Page 28/159

Member State in EEA
























Estonia Ebewe Pharma Ebetrex Methotrexate 10.97mg/Ml



Estonia Ebewe Pharma Ebetrex Methotrexate 21.94mg/Ml



Estonia Ebewe Pharma Methotrexate Ebewe



Estonia Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)




Metex Methotrexate 10mg/0.2ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 29/159

Member State in EEA





Metex Methotrexate 12.5mg/0.25ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 30/159

Member State in EEA







Subcutaneous Use

Estonia Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Estonia Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Estonia Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Finland Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Intravenous Use

Finland Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use

Annex I EMA/204541/2018 Page 31/159

Member State in EEA






Intravenous Use



Intravenous Use



Intravenous Use

Finland Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml









Finland Accord Healthcare Limited Methotrexat Accord Methotrexate 10mg Tablet

Tablet Oral Use

Finland Accord Healthcare Limited Methotrexat Accord Methotrexate 2.5mg Tablet

Tablet Oral Use

Finland Accord Healthcare Limited Methotrexate Accord






Annex I EMA/204541/2018 Page 32/159

Member State in EEA







Finland Ebewe Pharma Ebetrex Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Finland Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Finland Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 33/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 34/159

Member State in EEA




Finland Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Finland Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Finland Orion Corporation Trexan Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Finland Orion Oyj Trexan Methotrexate 2.5mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use

Finland Orion Oyj Trexan Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use

Finland Orion Oyj Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Finland Orion Oyj Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Finland Pfizer Oy Methotrexate Pfizer Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Finland Pfizer Oy Methotrexate Pfizer Methotrexate 25mg/Ml Solution For Injection/Infusion


France Accord Healthcare France Sas Methotrexate Accord




Annex I EMA/204541/2018 Page 35/159

Member State in EEA
























Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 36/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

France Laboratoire Biodim Ledertrexate Methotrexate 50mg/2ml

Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Subcutaneous Use

France Laboratoire Biodim Methotrexate Biodim

Methotrexate 2.5mg/Ml Solution For Injection Intraarterial Use | Intradiscal Use | Intramuscular Use | Intravenous Use | Subcutaneous Use

France Laboratoire Biodim Methotrexate Biodim

Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Subcutaneous Use

Annex I EMA/204541/2018 Page 37/159

Member State in EEA




France Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 38/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

France Mylan S.A.S Méthotrexate Mylan

Methotrexate 100mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use


Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use





Methotrexate 2.5mg/Ml Solution For Injection Intravenous Use

France Nordic Group B.V. Imeth Methotrexate 10mg Syringe



France Nordic Group B.V. Imeth Methotrexate 10mg/0.4ml



France Nordic Group B.V. Imeth Methotrexate 12.5mg Syringe



Annex I EMA/204541/2018 Page 39/159

Member State in EEA




France Nordic Group B.V. Imeth Methotrexate 12.5mg/0.5ml






























France Nordic Group B.V. Imeth Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Annex I EMA/204541/2018 Page 40/159

Member State in EEA










France Nordic Pharma Imeth Methotrexate 10mg Tablet

Tablet Oral Use

France Nordic Pharma Imeth Methotrexate 2.5mg Tablet

Tablet Oral Use

France Pfizer Holding France Novatrex Methotrexate 2.5mg Tablet

Tablet Oral Use

France Sanofi-Aventis France Methotrexate Bellon


Tablet Oral Use

France Teva Santé Methotrexate Teva Methotrexate 500mg/20ml

Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use | Subcutaneous Use

France Teva Santé Methotrexate Teva Methotrexate 5g/20ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use | Subcutaneous Use





Annex I EMA/204541/2018 Page 41/159

Member State in EEA




Germany Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml


Intravenous Use | Subcutaneous Use

Germany Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml



























Germany Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml


Annex I EMA/204541/2018 Page 42/159

Member State in EEA













Germany Accord Healthcare Limited Methotrexate Accord



Germany Accord Healthcare Limited Methotrexate Accord



Germany Addenda Pharma S.R.L. Aldesta Methotrexate 10mg/0.4ml


Subcutaneous Use

Germany Addenda Pharma S.R.L. Aldesta Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 43/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Germany Aliud Pharma Gmbh Methotrexat Al Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Germany Astron Research Limited Methotrexate Astron



Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 44/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Germany Bendalis Gmbh Bendatrexat Methotrexate 50mg/2ml

Solution For Injection Parenteral Use

Germany Hexal Ag Methotrexat Hexal Methotrexate 25mg/Ml Solution For Injection/Infusion


Germany Hexal Ag Mtx Methotrexate Disodium 10.96mg Vial

Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use | Subcutaneous Use



Annex I EMA/204541/2018 Page 45/159

Member State in EEA








Germany Hexal Ag Mtx Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Germany Hexal Ag Mtx Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Germany Hexal Ag Mtx Methotrexate Disodium 10.96mg Tablet

Tablet Oral Use


Tablet Oral Use


Tablet Oral Use


Tablet Oral Use


Tablet Oral Use

Germany Hexal Ag Neotrexat Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Annex I EMA/204541/2018 Page 46/159

Member State in EEA




Germany Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Metex Methotrexate Disodium 8.22mg/Ml

Solution For Injection Intramuscular Use | Intravenous Use | Oral Use | Subcutaneous Use





Metex Methotrexate Disodium 10.96mg Tablet

Tablet Oral Use



Tablet Oral Use



Tablet Oral Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 47/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use


Metex Pen Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Pen

Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 48/159

Member State in EEA





Methotrexat Medac Methotrexate 100mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use


Methotrexat Medac Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use


Methotrexat Medac Methotrexate Disodium 16.44mg/3ml

Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use


Trexject Methotrexate 10mg/Ml Solution For Injection In Pre-Filled Syringe


Germany Mundipharma Gmbh Methotrexat Mundipharma



Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 49/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Germany Mylan Dura Gmbh Mtx Methotrexate 7.5mg/Ml Solution For Injection Intramuscular Use | Intravenous Injection | Subcutaneous Use

Germany Orion Corporation Mtx Orion Methotrexate 10mg Tablet

Tablet Oral Use

Germany Orion Corporation Mtx Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Germany Pfizer Pharma Pfe Gmbh Lantarel Methotrexate Disodium 10.96mg Tablet

Tablet Oral Use


Tablet Oral Use


Tablet Oral Use

Germany Pfizer Pharma Pfe Gmbh Lantarel Fs Methotrexate Disodium 10.96mg/0.4ml



Annex I EMA/204541/2018 Page 50/159

Member State in EEA










Germany Pfizer Pharma Pfe Gmbh Lantarel Fs Methotrexate Disodium 27.41mg/Ml






Germany Pfizer Pharma Pfe Gmbh Methotrexat “lederle“


Tablet Oral Use

Germany Pfizer Pharma Pfe Gmbh Methotrexat “lederle“


Tablet Oral Use

Germany Pfizer Pharma Pfe Gmbh Methotrexat Lösung "lederle"

Methotrexate Disodium 1096mg Vial








Methotrexate Disodium 5483mg Vial









Annex I EMA/204541/2018 Page 51/159

Member State in EEA




Germany Rosemont Pharmaceuticals Limited

Methotrexat Rosemont

Methotrexate Disodium 2.19mg/Ml

Oral Solution Oral Use

Germany Stada Arzneimittel Ag Methotrexat Stada Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Subcutaneous Use

Germany Stadapharm Gmbh Methotrexat Stada Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Subcutaneous Use

Germany Teva Gmbh Methotrexat Gry Methotrexate Disodium 54.84mg/2ml


Germany Teva Gmbh Methotrexate Gry Methotrexate Disodium 1096.73mg/10ml











Greece Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Subcutaneous Use

Greece Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 52/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Greece Chemipharm S.G. De Tchaves & Cie E.E






Annex I EMA/204541/2018 Page 53/159

Member State in EEA








Emthexate Methotrexate 5mg/2ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use


Emthexate Methotrexate 2.5mg Tablet

Tablet Oral Use

Greece Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 54/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Greece Medicus A.E Methobion Methotrexate 1000mg/40ml




Annex I EMA/204541/2018 Page 55/159

Member State in EEA






Greece Pfizer Hellas, A.E. Methotrexate Pfizer Methotrexate 1000mg/40ml



Greece Pfizer Hellas, A.E. Methotrexate Pfizer Methotrexate 2.5mg Tablet

Tablet Oral Use

Hungary Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml



Hungary Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml


















Annex I EMA/204541/2018 Page 56/159

Member State in EEA
















Hungary Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml















Annex I EMA/204541/2018 Page 57/159

Member State in EEA




Hungary Actavis Group Ptc Ehf. Namaxir Methotrexate 20mg/0.5ml


Hungary Actavis Group Ptc Ehf. Namaxir Methotrexate 22.5mg/0.56ml








Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use

Annex I EMA/204541/2018 Page 58/159

Member State in EEA






Intravenous Use



Intravenous Use



Intravenous Use



Subcutaneous Use



Subcutaneous Use

Hungary Ebewe Pharma Ebetrexat Methotrexate Disodium 20mg/Ml


Hungary Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Hungary Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Hungary Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use

Annex I EMA/204541/2018 Page 59/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 60/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Hungary Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Hungary Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Hungary Orion Corporation Methotrexate Orion Methotrexate 25mg Tablet

Tablet Oral Use

Hungary Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Hungary Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Hungary Sandoz Hungária Kft Ebetrexat Methotrexate Disodium 21.94mg/Ml



Hungary Sandoz Hungária Kft Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Hungary Sandoz Hungária Kft Methotrexat Ebewe Methotrexate 10mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Annex I EMA/204541/2018 Page 61/159

Member State in EEA




Iceland Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Subcutaneous Use

Iceland Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 62/159

Member State in EEA




Iceland Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)




Metojectpen Methotrexate 10mg/0.2ml


Subcutaneous Use


Metojectpen Methotrexate 12.5mg/0.25ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 63/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Iceland Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Iceland Pfizer Aps Methotrexate Pfizer Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Iceland Pfizer Aps Methotrexate Pfizer Methotrexate 25mg/Ml Solution For Injection/Infusion


Iceland Pfizer Aps Methotrexate Pfizer Methotrexate 2.5mg Tablet

Tablet Oral Use

Ireland Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml



Ireland Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml



Annex I EMA/204541/2018 Page 64/159

Member State in EEA





























Solution For Injection In Pre-Filled Injector

Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 65/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Ireland Accord Healthcare Limited Methotrexate Accord Healthcare









Annex I EMA/204541/2018 Page 66/159

Member State in EEA


















Tablet Oral Use



Tablet Oral Use

Ireland Hospira Uk Ltd Methotrexate Hospira Uk

Methotrexate 2.5mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use




Methotrexate 100mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use





Tablet Oral Use

Annex I EMA/204541/2018 Page 67/159

Member State in EEA






Tablet Oral Use

Ireland Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Ireland Mercury Pharmaceuticals Ltd. Methotrexate Mercury Pharmaceuticals


Tablet Oral Use

Annex I EMA/204541/2018 Page 68/159

Member State in EEA




Ireland Morningside Healthcare Ltd Methotrexate Morningside Healthcare


Tablet Oral Use

Ireland Morningside Healthcare Ltd Methotrexate Morningside Healthcare


Tablet Oral Use

Ireland Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Ireland Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Ireland Rosemont Pharmaceuticals Limited

Methotrexate Rosemont Pharmaceuticals



Italy Accord Healthcare Limited Metother Methotrexate 10mg/0.2ml


Subcutaneous Use

Italy Accord Healthcare Limited Metother Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 69/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Italy Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml












Annex I EMA/204541/2018 Page 70/159

Member State in EEA







Italy Accord Healthcare Limited Metotrexato Accord Healthcare Limited


Tablet Oral Use

Italy Addenda Pharma S.R.L. Metotrexato Addenda



Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 71/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Italy Alfasigma S.P.A. Reumaflex Methotrexate 10mg/0.2ml



Italy Alfasigma S.P.A. Reumaflex Methotrexate 12.5mg/0.25ml





















Italy Difa Cooper S.P.A. Velos Methotrexate 27.5mg/0.69ml


Injection

Annex I EMA/204541/2018 Page 72/159

Member State in EEA




Italy Difa Cooper S.P.A. Velos Methotrexate 10mg/0.4ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 73/159

Member State in EEA




Italy Doc Generici S.R.L. Metotrexato Doc Generici



Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 74/159

Member State in EEA




Italy Mundipharma Pharmaceuticals Srl

Immutrex Methotrexate 10mg/0.4ml


Subcutaneous Use


Immutrex Methotrexate 12.5mg/0.31ml


Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 75/159

Member State in EEA




Italy Pfizer Italia S.R.L. Methotrexate Pfizer Italia

Methotrexate Sodium 5.484mg Vial

Powder For Solution For Injection

Intraarterial Use | Intramuscular Use | Intrathecal Use | Intratumoral Use | Intravenous Use


Methotrexate Sodium 10.968mg/1.33ml




Methotrexate Sodium 16.452mg/2ml




Methotrexate Sodium 21.936mg/2.66ml




Methotrexate Sodium 8.226mg/Ml




Methotrexate Sodium 1.097g Vial







Annex I EMA/204541/2018 Page 76/159

Member State in EEA









Methotrexate Sodium 1.097g/10ml

Solution For Injection Intramuscular Use | Intravenous Use


Methotrexate Sodium 5.484g/50ml









Methotrexate Sodium 2.742mg Tablet

Tablet Oral Use

Italy Pfizer Italia S.R.L. Metotrexato Pfizer Methotrexate 100mg Vial


Italy Pfizer Italia S.R.L. Metotrexato Pfizer Methotrexate 1g Bottle Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Italy Pfizer Italia S.R.L. Metotrexato Pfizer Methotrexate 500mg Bottle


Italy Pfizer Italia S.R.L. Metotrexato Pfizer Methotrexate 50mg Vial Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Annex I EMA/204541/2018 Page 77/159

Member State in EEA




Italy Pfizer Italia S.R.L. Metotrexato Pfizer Methotrexate 5mg Vial Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Italy S.F. Group Srl Afslamet Methotrexate 22.5mg/0.56ml


Intravenous Use

Italy S.F. Group Srl Afslamet Methotrexate 10mg/0.4ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 78/159

Member State in EEA






Subcutaneous Use

Italy Teva Italia S.R.L. Metotressato Teva Methotrexate 100mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Italy Teva Italia S.R.L. Metotressato Teva Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Latvia Accord Healthcare Limited Methotrexate Accord












Latvia Ebewe Pharma Ebetrex Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Latvia Ebewe Pharma Methotrexate Ebewe


Tablet Oral Use

Latvia Ebewe Pharma Methotrexate Ebewe


Tablet Oral Use

Annex I EMA/204541/2018 Page 79/159

Member State in EEA




Latvia Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 80/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Latvia Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Latvia Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Latvia Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Latvia Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Lithuania Accord Healthcare Limited Methotrexate Accord






Annex I EMA/204541/2018 Page 81/159

Member State in EEA



















Lithuania Accord Healthcare Limited Metother Methotrexate 10mg/0.2ml



Lithuania Accord Healthcare Limited Metother Methotrexate 12.5mg/0.25ml


















Annex I EMA/204541/2018 Page 82/159

Member State in EEA















Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 83/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use

Lithuania Ebewe Pharma Ebetrexat Methotrexate Disodium 20mg/Ml


Lithuania Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Injection/Infusion


Lithuania Ebewe Pharma Methotrexat Ebewe Methotrexate 2.5mg Tablet

Tablet Oral Use

Lithuania Ebewe Pharma Methotrexat Ebewe Methotrexate 5mg Tablet

Tablet Oral Use

Lithuania Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 84/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 85/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Lithuania Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Lithuania Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Lithuania Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Lithuania Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Luxembourg Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 5.48mg

Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use

Luxembourg Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 8.23mg/Ml



Luxembourg Pfizer S.A. (Belgium) Ledertrexate Methotrexate Disodium 2.74mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 86/159

Member State in EEA




Luxembourg Pfizer S.A. (Belgium) Ledertrexate Concentrate




Luxembourg Pfizer S.A. (Belgium) Ledertrexate Concentrate




Luxembourg Teva Pharma Belgium N.V./S.A

Emthexate Methotrexate 25mg/Ml Injection Epidural Use | Intrabursal Use | Intracoronary Use | Intradiscal Use | Intramuscular Use | Intravenous Use | Perineural Use | Retrobulbar Use


Emthexate Methotrexate 2.5mg/Ml Solution For Injection Intraarterial Use | Intracoronary Use | Intramuscular Use | Intrathecal Use | Intravenous Use



Solution For Injection Intraarterial Use | Intracoronary Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Malta Accord Healthcare Limited Methotrexate Accord Healthcare



Annex I EMA/204541/2018 Page 87/159

Member State in EEA















Tablet Oral Use



Tablet Oral Use

Malta Actavis Group Ptc Ehf. Methotrexate Actavis



Malta Hospira Uk Ltd Methotrexate Hospira Uk






Methotrexate 1g/10ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use

Annex I EMA/204541/2018 Page 88/159

Member State in EEA








Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use






Netherlands Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Netherlands Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 89/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Netherlands Accord Healthcare Limited Methotrexaat Accord





















Netherlands Addenda Pharma S.R.L. Aldesta Methotrexate 10mg/0.4ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 90/159

Member State in EEA




Netherlands Addenda Pharma S.R.L. Aldesta Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Netherlands Aurobindo Pharma B.V. Methotrexaat Aurobindo



Annex I EMA/204541/2018 Page 91/159

Member State in EEA




Netherlands Centrafarm B.V. Methotrexaat Cf Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Netherlands Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)




























Annex I EMA/204541/2018 Page 92/159

Member State in EEA



















Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 93/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Netherlands Mylan B.V. Methotrexaat Mylan

Methotrexate 100mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection


Methotrexate 2.5mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection


Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection

Netherlands Nordic Group B.V. Methotrexaat Nordic

Methotrexate 10mg Syringe



Annex I EMA/204541/2018 Page 94/159

Member State in EEA





Methotrexate 12.5mg Syringe



























Netherlands Pharmachemie B.V Emthexate Pf Methotrexate 100mg Vial


Netherlands Pharmachemie B.V Emthexate Pf Methotrexate 25mg Vial Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use

Netherlands Pharmachemie B.V Emthexate Pf Methotrexate 5mg Vial Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use

Netherlands Pharmachemie B.V Methotrexaat Pch Methotrexate 10mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 95/159

Member State in EEA




Netherlands Pharmachemie B.V Methotrexaat Pch Methotrexate 2.5mg Tablet

Tablet Oral Use

Netherlands Sandoz B.V. Ebetrex Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Netherlands Sandoz B.V. Ebetrex Methotrexate Disodium 21.94mg/Ml



Netherlands Sandoz B.V. Methotrexaat Sandoz





Intravenous Use


Methotrexate Disodium 10mg Tablet

Tablet Oral Use



Tablet Oral Use



Tablet Oral Use

Netherlands Sandoz B.V. Methotrexaat Sandoz B.V.

Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use

Netherlands Sandoz B.V. Methotrexaat Sandoz B.V.

Methotrexate 25mg/Ml Solution For Injection Intravenous Use

Netherlands Teva Nederland B.V. Methotrexaat Teva Methotrexate 10mg/0.4ml



Annex I EMA/204541/2018 Page 96/159

Member State in EEA




Netherlands Teva Nederland B.V. Methotrexaat Teva Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Pen


Netherlands Teva Nederland B.V. Methotrexaat Teva Methotrexate 10mg Syringe



Netherlands Teva Nederland B.V. Methotrexaat Teva Methotrexate 12.5mg Syringe





















Netherlands Teva Nederland B.V. Methotrexaat Teva Methotrexate 12.5mg/0.5ml






Annex I EMA/204541/2018 Page 97/159

Member State in EEA
















Netherlands Teva Pharma B.V. Methotrexate Teva Methotrexate 100mg/Ml Powder For Solution For Injection


Netherlands Teva Pharma B.V. Methotrexate Teva Methotrexate 2.5mg/Ml Powder For Solution For Injection


Netherlands Teva Pharma B.V. Methotrexate Teva Methotrexate 25mg/Ml Powder For Solution For Injection


Norway Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml


Subcutaneous Use

Norway Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 98/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Norway Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml









Annex I EMA/204541/2018 Page 99/159

Member State in EEA










Norway Accord Healthcare Limited Methotrexate Accord


Tablet Oral Use

Norway Actavis Group Ptc Ehf. Remianza Methotrexate 10mg/0.4ml


Norway Actavis Group Ptc Ehf. Remianza Methotrexate 12.5mg/0.31ml










Annex I EMA/204541/2018 Page 100/159

Member State in EEA














Norway Cipla Europe Nv Methotrexate Cipla Methotrexate 2.5mg Tablet

Tablet Oral Use

Norway Ebewe Pharma Ebetrex Methotrexate Disodium 21.94mg/Ml



Norway Ebewe Pharma Ebetrex Methotrexate 100ml/Ml Concentrate For Solution For Infusion

Intravenous Use

Norway Ebewe Pharma Ebetrex Methotrexate 2.5mg Tablet

Tablet Oral Use

Norway Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)



Annex I EMA/204541/2018 Page 101/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 102/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Norway Orion Corporation Methotrexate Orion Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Norway Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Norway Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Norway Pfizer As Methotrexate Pfizer Methotrexate 25mg/Ml Solution For Injection/Infusion


Norway Pfizer As Methotrexate Pfizer Methotrexate 2.5mg Tablet

Tablet Oral Use

Norway Teva Sweden Ab Methotrexate Teva Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intraarterial Use | Intravenous Use

Norway Teva Sweden Ab Methotrexate Teva Methotrexate 2.5mg Tablet

Tablet Oral Use

Poland Accord Healthcare Limited Methofill Methotrexate 10mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 103/159

Member State in EEA




Poland Accord Healthcare Limited Methofill Methotrexate 2.5mg Tablet

Tablet Oral Use

Poland Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml


Subcutaneous Use

Poland Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 104/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Poland Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/40ml


Annex I EMA/204541/2018 Page 105/159

Member State in EEA

















Poland Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Subcutaneous Use

Poland Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 106/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Poland Ebewe Pharma Ebetrexat Methotrexate Disodium 21.94mg/Ml



Poland Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg/Ml Solution For Injection/Infusion


Poland Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Poland Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg Tablet

Tablet Oral Use

Poland Ebewe Pharma Methotrexat Ebewe Methotrexate 2.5mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 107/159

Member State in EEA




Poland Ebewe Pharma Methotrexat Ebewe Methotrexate 5mg Tablet

Tablet Oral Use

Poland Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 108/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use


Metotab Methotrexate 10mg Tablet

Tablet Oral Use


Metotab Methotrexate 2.5mg Tablet

Tablet Oral Use



Tablet Oral Use

Poland Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 109/159

Member State in EEA




Poland Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Poland Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Poland Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Portugal Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml















Portugal Addenda Pharma S.R.L. Aldesta Methotrexate 10mg/0.4ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 110/159

Member State in EEA




Portugal Addenda Pharma S.R.L. Aldesta Methotrexate 12.5mg/0.3125ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Portugal Laboratórios Pfizer, Lda. Fauldexato Methotrexate 100mg/4ml


Annex I EMA/204541/2018 Page 111/159

Member State in EEA




Portugal Laboratórios Pfizer, Lda. Fauldexato Methotrexate 2.5mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use



Portugal Laboratórios Pfizer, Lda. Fauldexato Methotrexate 1g/10ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use



Portugal Laboratórios Pfizer, Lda. Fauldexato Methotrexate 5g/50ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use

Portugal Laboratórios Pfizer, Lda. Ledertrexato Methotrexate 2.5mg Tablet

Tablet Oral Use

Portugal Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 112/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 113/159

Member State in EEA




Portugal Teva Pharma – Produtos Farmacêuticos Lda

Methotrexate Teva Methotrexate 26mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use


Methotrexato Teva Methotrexate 104mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use


Metotrexato Teva Methotrexate 1040mg/20ml



Metotrexato Teva Methotrexate 52mg/2ml



Metotrexato Teva Methotrexate 26ml/Ml Solution For Injection Intramuscular Use

Romania Accord Healthcare Limited Methofill Methotrexate 10mg Tablet

Tablet Oral Use

Romania Accord Healthcare Limited Methofill Methotrexate 2.5mg Tablet

Tablet Oral Use

Romania Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Intravenous Use

Romania Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Intravenous Use



Intravenous Use

Annex I EMA/204541/2018 Page 114/159

Member State in EEA






Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use

Romania Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Injection/Infusion


Romania Ebewe Pharma Methotrexat Ebewe Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Romania Ebewe Pharma Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml


Annex I EMA/204541/2018 Page 115/159

Member State in EEA




Romania Ebewe Pharma Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml



Romania Ebewe Pharma Metotrexate Ebewe Methotrexate 10mg/Ml Solution For Injection Intravenous Use

Romania Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)






Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 116/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Romania S.C. Rompharm Company S.R.L.

Metorthrit Methotrexate 10mg/Ml Solution For Injection In Pre-Filled Syringe



Metorthrit Methotrexate 15mg/1.5ml




Metorthrit Methotrexate 20mg/2ml




Metorthrit Methotrexate 7.5mg/0.75ml



Slovakia Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Slovakia Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 117/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Slovakia Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml






Annex I EMA/204541/2018 Page 118/159

Member State in EEA







Slovakia Accord Healthcare Limited Metotrexát Accord Methotrexate 1000mg/40ml






Slovakia Ebewe Pharma Methotrexat Ebewe Methotrexate 100mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use

Slovakia Ebewe Pharma Methotrexat Ebewe Methotrexate 10mg/Ml Solution For Injection In Pre-Filled Syringe


Slovakia Ebewe Pharma Methotrexat Ebewe Methotrexate 20mg/Ml Solution For Injection In Pre-Filled Syringe


Slovakia Ebewe Pharma Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml



Slovakia Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)



Annex I EMA/204541/2018 Page 119/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 120/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use

Slovakia Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

Slovakia Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Slovakia Orion Corporation Trexan Methotrexate 10mg Tablet

Tablet Oral Use

Slovakia Orion Corporation Trexan Methotrexate 2.5mg Tablet

Tablet Oral Use

Slovakia Sandoz Pharmaceuticals D.D. Methotrexat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Slovakia Teva Pharmaceuticals Slovakia S.R.O

Methotrexate Teva Methotrexate Sodium 10mg Tablet

Tablet Oral Use

Slovakia Teva Pharmaceuticals Slovakia S.R.O

Methotrexate Teva Methotrexate Sodium 2.5mg Tablet

Tablet Oral Use

Slovenia Actavis Group Ptc Ehf. Metotreksat Actavis



Annex I EMA/204541/2018 Page 121/159

Member State in EEA




Slovenia Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Subcutaneous Use

Slovenia Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 122/159

Member State in EEA




Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate Disodium 10mg/Ml


Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate 20mg/Ml Solution For Injection In Pre-Filled Syringe


Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate Disodium 21.94mg/Ml



Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intravenous Use

Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate 10mg Tablet

Tablet Oral Use

Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate 2.5mg Tablet

Tablet Oral Use

Slovenia Ebewe Pharma Metotreksat Ebewe Methotrexate 5mg Tablet

Tablet Oral Use

Slovenia Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)





Metoject Methotrexate 15mg/30ml







Annex I EMA/204541/2018 Page 123/159

Member State in EEA














Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 124/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Spain Accord Healthcare S.L.U. Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Spain Accord Healthcare S.L.U. Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 125/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Spain Accord Healthcare S.L.U. Methofill Methotrexate 10mg/0.2ml


Subcutaneous Use

Spain Accord Healthcare S.L.U. Methofill Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 126/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Spain Accord Healthcare S.L.U. Metotrexato Accord Methotrexate 1000mg/40ml















Spain Addenda Pharma S.R.L. Aldesta Methotrexate 10mg/0.4ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 127/159

Member State in EEA




Spain Addenda Pharma S.R.L. Aldesta Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Spain Cipla Europe Nv Metotrexato Cipla Methotrexate 2.5mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 128/159

Member State in EEA




Spain Ebewe Pharma Bertanel Methotrexate 10mg/0.5ml



Spain Ebewe Pharma Bertanel Methotrexate 12.5mg/0.625ml









Spain Ebewe Pharma Bertanel Methotrexate 20mg/Ml Solution For Injection In Pre-Filled Syringe














Spain Ebewe Pharma Bertanel Methotrexate Disodium 21.94mg/Ml



Spain Ebewe Pharma Bertanel Methotrexate 10mg/Ml Solution For Injection Intravenous Use

Annex I EMA/204541/2018 Page 129/159

Member State in EEA




Spain Ebewe Pharma Metotrexato Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Spain Especialidades Farmaceuticas Centrum, S.A

Quinux Methotrexate 10mg/0.4ml












Quinux Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe



Quinux Methotrexate 7.5mg/0.3ml



Spain Laboratorio Stada, S.L. Glofer Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Spain Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)












Annex I EMA/204541/2018 Page 130/159

Member State in EEA



































Subcutaneous Use

Annex I EMA/204541/2018 Page 131/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 132/159

Member State in EEA







Subcutaneous Use

Spain Mylan Pharmaceuticals S.L. Metotrexato Mylan Methotrexate 25mg/Ml Solution For Injection/Infusion


Spain Nordic Group B.V. Imeth Methotrexate 10mg/0.4ml



Spain Nordic Group B.V. Imeth Methotrexate 12.5mg/0.5ml



Spain Nordic Group B.V. Imeth Methotrexate 15mg/0.6ml






Spain Nordic Group B.V. Imeth Methotrexate 20mg Syringe






Spain Nordic Group B.V. Imeth Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe





Annex I EMA/204541/2018 Page 133/159

Member State in EEA




Spain Pfizer, S.L. Metotrexato Pfizer Methotrexate 25mg/Ml Solution For Injection Intramuscular Use | Intravenous Use

Spain Wyeth Farma, S.A Metotrexato Wyeth Methotrexate Sodium 1g/40ml


Spain Wyeth Farma, S.A Metotrexato Wyeth Methotrexate Sodium 500mg/20ml


Spain Wyeth Farma, S.A Metotrexato Wyeth Methotrexate Sodium 5g/200ml


Spain Wyeth Farma, S.A Metotrexato Wyeth Methotrexate 2.5mg Tablet

Tablet Oral Use

Sweden Accord Healthcare Limited Injexate Methotrexate 10mg/0.2ml


Subcutaneous Use

Sweden Accord Healthcare Limited Injexate Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 134/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Sweden Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/10ml













Annex I EMA/204541/2018 Page 135/159

Member State in EEA






Sweden Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Intravenous Use

Sweden Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use



Intravenous Use

Annex I EMA/204541/2018 Page 136/159

Member State in EEA






Intravenous Use

Sweden Addenda Pharma S.R.L. Methotrexate Addenda



Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 137/159

Member State in EEA







Subcutaneous Use

Sweden Astron Research Limited Metotrexat Astron Methotrexate 10mg/0.2ml


Subcutaneous Use

Sweden Astron Research Limited Metotrexat Astron Methotrexate 12.5mg/0.25ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 138/159

Member State in EEA




Sweden Cipla Europe Nv Methotrexate Cipla Methotrexate 10mg Tablet

Tablet Oral Use

Sweden Cipla Europe Nv Methotrexate Cipla Methotrexate 2.5mg Tablet

Tablet Oral Use

Sweden Difa Cooper S.P.A. Velos Methotrexate 10mg/0.4ml


Injection

Sweden Difa Cooper S.P.A. Velos Methotrexate 12.5mg/0.31ml


Injection



Injection



Injection



Injection



Injection



Injection



Solution For Injection



Subcutaneous Use

Annex I EMA/204541/2018 Page 139/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use

Sweden Ebewe Pharma Ebetrex Methotrexate Disodium 21.94mg/Ml


Sweden Ebewe Pharma Ebetrex Methotrexate 10mg Tablet

Tablet Oral Use

Sweden Ebewe Pharma Ebetrex Methotrexate 2.5mg Tablet

Tablet Oral Use

Sweden Ebewe Pharma Ebetrex Methotrexate 5mg Tablet

Tablet Oral Use

Sweden Ebewe Pharma Methotrexate Ebewe



Sweden Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)









Subcutaneous Use

Annex I EMA/204541/2018 Page 140/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 141/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use


Metopen Methotrexate 10mg/0.2ml


Subcutaneous Use


Metopen Methotrexate 12.5mg/0.25ml


Subcutaneous Use

Annex I EMA/204541/2018 Page 142/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 143/159

Member State in EEA





Metotab Methotrexate 10mg Tablet

Tablet Oral Use



Tablet Oral Use



Tablet Oral Use


Metotrexat Medac Methotrexate 50mg/Ml Solution For Injection In Pre-Filled Syringe


Sweden Orion Corporation Methotrexate Orion Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe


Sweden Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

Sweden Orion Corporation Methotrexate Orion Pharma


Tablet Oral Use

Sweden Orion Corporation Methotrexate Orion Pharma


Tablet Oral Use

Sweden Pfizer Ab Methotrexate Pfizer Methotrexate 100mg/Ml Concentrate For Solution For Infusion


Annex I EMA/204541/2018 Page 144/159

Member State in EEA




Sweden Pfizer Ab Methotrexate Pfizer Methotrexate 25mg/Ml Solution For Injection/Infusion


Sweden Sigillata Limited Husmetabo Methotrexate 10mg/0.4ml


Subcutaneous Use

Sweden Sigillata Limited Husmetabo Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 145/159

Member State in EEA






Subcutaneous Use

Sweden Teva Sweden Ab Methotrexate Teva Methotrexate 100mg/Ml Concentrate For Solution For Infusion

Intraarterial Use | Intravenous Use

United Kingdom Accord Healthcare Limited Methofill Methotrexate 10mg/0.2ml



United Kingdom Accord Healthcare Limited Methofill Methotrexate 12.5mg/0.25ml
























Annex I EMA/204541/2018 Page 146/159

Member State in EEA









Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 147/159

Member State in EEA




United Kingdom Accord Healthcare Limited Methotrexate Accord



United Kingdom Accord Healthcare Limited Methotrexate Accord Healthcare


















United Kingdom Actavis Group Ptc Ehf. Namaxir Methotrexate 10mg/0.4ml


Subcutaneous Use

United Kingdom Actavis Group Ptc Ehf. Namaxir Methotrexate 12.5mg/0.31ml


Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

Annex I EMA/204541/2018 Page 148/159

Member State in EEA






Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use



Subcutaneous Use

United Kingdom Cipla (Eu) Limited Methotrexate Cipla (Eu)


Tablet Oral Use

United Kingdom Cipla (Eu) Limited Methotrexate Cipla (Eu)


Tablet Oral Use

United Kingdom Ebewe Pharma Ebetrex Methotrexate 10mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

United Kingdom Ebewe Pharma Ebetrex Methotrexate 20mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use

Annex I EMA/204541/2018 Page 149/159

Member State in EEA




United Kingdom Ebewe Pharma Methotrexate Ebewe Pharma




Tablet Oral Use



Tablet Oral Use

United Kingdom Hameln Pharmaceuticals Ltd Methotrexate Hameln Pharmaceuticals

Methotrexate 25mg/Ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use


Methotrexate 5mg/2ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use







United Kingdom Hospira Uk Ltd Methotrexate Hospira Uk

Methotrexate 1g/40ml Solution For Injection Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use

Annex I EMA/204541/2018 Page 150/159

Member State in EEA





















Tablet Oral Use



Tablet Oral Use

United Kingdom Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

Methotrexate Medac


Annex I EMA/204541/2018 Page 151/159

Member State in EEA





Methotrexate Medac








Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

Annex I EMA/204541/2018 Page 152/159

Member State in EEA







Subcutaneous Use




Subcutaneous Use




Subcutaneous Use




Subcutaneous Use

United Kingdom Mercury Pharmaceuticals Ltd. Methotrexate Mercury Pharmaceuticals


Tablet Oral Use

United Kingdom Morningside Healthcare Ltd Methotrexate Morningside Healthcare


Tablet Oral Use

United Kingdom Morningside Healthcare Ltd Methotrexate Morningside Healthcare


Tablet Oral Use

United Kingdom Nordic Group B.V. Zlatal Methotrexate 10mg/0.4ml



Annex I EMA/204541/2018 Page 153/159

Member State in EEA




United Kingdom Nordic Group B.V. Zlatal Methotrexate 12.5mg/0.5ml















United Kingdom Nordic Group B.V. Zlatal Methotrexate 25mg/Ml Solution For Injection In Pre-Filled Syringe





United Kingdom Orion Corporation Methotrexate Orion Methotrexate 10mg Tablet

Tablet Oral Use

United Kingdom Orion Corporation Methotrexate Orion Methotrexate 2.5mg Tablet

Tablet Oral Use

United Kingdom Pfizer Limited Maxtrex Methotrexate 10mg Tablet

Tablet Oral Use

United Kingdom Pfizer Limited Maxtrex Methotrexate 2.5mg Tablet

Tablet Oral Use

Annex I EMA/204541/2018 Page 154/159

Member State in EEA




United Kingdom Rosemont Pharmaceuticals Limited

Methotrexate Rosemont Pharmaceuticals



Centrally authorised medicinal products

MA (EU) number (Invented) name

Strength Pharmaceutical Form


Immediate Packaging

Content (concentration)

Pack size

EU/1/17/1172/001 Jylamvo 2 mg/ml Oral solution Oral use bottle (glass) 60 ml 1 bottle + 1 bottle adaptor + 1 dosing syringe 10 ml




Immediate Packaging


Pack size

EU/1/16/1124/001 Nordimet 7.5 mg Solution for injection

Subcutaneous use

pre-filled syringe (glass) in pre-filled pen

0.3 ml 1 pre-filled pen + 1 swab

EU/1/16/1124/002 Nordimet 10 mg Solution for injection

Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use



Annex I EMA/204541/2018 Page 155/159




Immediate Packaging


Pack size


Subcutaneous use




Subcutaneous use




Subcutaneous use


1 ml 1 pre-filled pen + 1 swab


Subcutaneous use


0.3 ml 4 (4 x 1) pre-filled pens + 4 (4 x 1) swabs (multipack)


Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use


0.6 ml 6 (6 x 1) pre-filled pens + 6 (6 x 1) swab (multipack)


Subcutaneous use



Annex I EMA/204541/2018 Page 156/159




Immediate Packaging


Pack size


Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use


1 ml 4 (4 x 1) pre-filled pens + 4 (4 x 1) swabs (multipack)


Subcutaneous use


1 ml 6 (6 x 1) pre-filled pens + 6 (6 x 1) swabs (multipack)


Subcutaneous use

pre-filled syringe (glass) with safety device

0.3 ml 1 pre-filled syringe + 2 swabs


Subcutaneous use


0.3 ml 4 (4 x 1) pre-filled syringes + 8 (4 x 2) swabs (multipack)


Subcutaneous use




Subcutaneous use



Annex I EMA/204541/2018 Page 157/159




Immediate Packaging


Pack size


Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use



Annex I EMA/204541/2018 Page 158/159




Immediate Packaging


Pack size


Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use




Subcutaneous use


1 ml 1 pre-filled syringe + 2 swabs

Annex I EMA/204541/2018 Page 159/159




Immediate Packaging


Pack size


Subcutaneous use


1 ml 4 (4 x 1) pre-filled syringes + 8 (4 x 2) swabs (multipack)


Subcutaneous use


1 ml 6 (6 x 1) pre-filled syringes + 12 (6 x 2) swabs (multipack)

Documents

Methotrexate - Art 31PhV - List of products Rev 1 · 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000Facsimile