Annex I List of medicinal products and presentations · List of medicinal products and...

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1 Annex I List of medicinal products and presentations

Transcript of Annex I List of medicinal products and presentations · List of medicinal products and...

Page 1: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

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Annex I

List of medicinal products and presentations

Page 2: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Austria Sandoz Gmbh Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Implantation

Austria Sandoz Gmbh Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Implantation

Austria Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Austria Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Austria Takeda Pharma Ges.M.B.H.

Enantone Monats-Depot

Leuprorelin Acetate 3.75mg/Ml

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Austria Takeda Pharma Ges.M.B.H.

Enantone-Gyn Monats-Depot

Leuprorelin Acetate 3.75mg/Ml

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Austria Takeda Pharma Ges.M.B.H.

Sixantone Leuprorelin Acetate 30mg/Ml

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Austria Takeda Pharma Ges.M.B.H.

Trenantone Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Austria Astellas Pharma Ges.M.B.H.

Eligard Depot Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Austria Astellas Pharma Ges.M.B.H.

Eligard Depot Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Austria Astellas Pharma Ges.M.B.H.

Eligard Depot Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Belgium Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Belgium Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Belgium Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Bulgaria Angelini Pharma Bulgaria Eood

Лутрат Депо Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Bulgaria Angelini Pharma Bulgaria Eood

Лутрат Депо Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Bulgaria Astellas Pharma D.O.O. Елигард Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Croatia Sandoz D.O.O. Lerin Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Implantation

Croatia Pharmas D.O.O. Lutrate Depo Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Croatia Pharmas D.O.O. Lutrate Depo Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Croatia Abbvie D.O.O. (Croatia) Lupron Depo Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Croatia Abbvie D.O.O. (Croatia) Lupron Depo Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Croatia Astellas D.O.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Croatia Astellas D.O.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Croatia Astellas D.O.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Cyprus Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Cyprus Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Cyprus Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Czech Republic Angelini Pharma Česká Republika S.R.O.

Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Czech Republic Angelini Pharma Česká Republika S.R.O.

Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Czech Republic Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Czech Republic Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Czech Republic Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Czech Republic Sandoz S.R.O. Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Denmark Astellas Pharma A/S Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Denmark Astellas Pharma A/S Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Denmark Astellas Pharma A/S Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Denmark Sandoz A/S Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Denmark Sandoz A/S Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Estonia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Estonia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Estonia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Finland Abbvie Oy Procren Depot Pds Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Finland Astellas Pharma A/S Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Finland Astellas Pharma A/S Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Finland Astellas Pharma A/S Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Finland Orion Corporation Enanton Depot Dual Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Finland Orion Corporation Enanton Depot Dual Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 11.25mg

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 3.75mg

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Finland Orion Oyj Enanton Depot Set Leuprorelin Acetate 30mg Vial

Powder And Solvent For Suspension For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Finland Orion Oyj Enanton Depot Dual Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

France Gp-Pharm S.A. Zeulide Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

France Gp-Pharm S.A. Zeulide Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

France Takeda France S.A.S. Enantone Lp Leuprorelin 11.25mg Syringe

Powder And Solvent For Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

France Takeda France S.A.S. Enantone Lp Leuprorelin 3.75mg Syringe

Powder And Solvent For Solution For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

France Takeda France S.A.S. Enantone L.P Leuprorelin 3.75mg Bottle

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

France Takeda France S.A.S. Enantone L.P Leuprorelin 11.25mg Bottle

Powder For Solution For Injection

Intramuscular Use / Subcutaneous Use

France Astellas Pharma Sas Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

France Astellas Pharma Sas Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

France Astellas Pharma Sas Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

France Sandoz Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

France Takeda France S.A.S. Enantone Lp Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Germany Gp-Pharm S.A. Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Germany Gp-Pharm S.A. Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Germany Takeda Gmbh Enantone-Gyn Monats-Depot

Leuprorelin Acetate 3.75mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Germany Takeda Gmbh Klebrocid 3-Monats-Depot

Leuprorelin Acetate 11.25mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Germany Takeda Gmbh Klebrocid Depot Zweikammerspritze

Leuprorelin Acetate 3.75mg Syringe

Prolonged-Release Suspension For

Intramuscular Use / Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Injection In Pre-Filled Syringe

Germany Takeda Gmbh Trenantone Leuprorelin Acetate 11.25mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Germany Takeda Gmbh Trenantone-Gyn Leuprorelin Acetate 11.25mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Germany Takeda Gmbh Enantone Monats-Depot

Leuprorelin Acetate 3.75mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Germany Astellas Pharma Europe B.V.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Germany Astellas Pharma Europe B.V.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Germany Astellas Pharma Europe B.V.

Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Germany Endomedica Gmbh Leugon Leuprorelin 10.72mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leupro-Sandoz 1-Monats-Depot

Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leupro-Sandoz 3-Monats-Depot

Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Germany Hexal Ag Leuprone 1-Monatsdepot

Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leuprone 3-Monatsdepot

Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leuprorelin Hexal Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Hexal Ag Leuprorelin Hexal Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Ratiopharm Gmbh Leuprolin Ratiopharm Leuprorelin Acetate 11.25mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Germany Takeda Gmbh Sixantone Leuprorelin Acetate 30mg Syringe

Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Greece Vianex S.A. Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Greece Vianex S.A. Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Greece Pharmazac Sa Leuprol Leuprorelin Acetate 11.25mg Vial

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Greece Pharmazac Sa Leuprol Leuprorelin Acetate 3.75mg Vial

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Greece Takeda Hellas S.A. Elityran Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Greece Takeda Hellas S.A. Elityran Leuprorelin Acetate 3.75mg Vial

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Greece Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Greece Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Greece Astellas Pharmaceuticals A.E.B.E.

Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Greece Sandoz Gmbh Prostaplant Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Greece Sandoz Pharmaceuticals D.D.

Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Hungary Gedeon Richter Plc. Politrate Depot Leuprorelin Acetate 22.5mg Vial | Water For Injection 2ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Hungary Gedeon Richter Plc. Politrate Depot Leuprorelin Acetate 3.75mg Vial | Water For Injection 2ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Hungary Abbvie Kft Lucrin Pds Depot Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Hungary Abbvie Kft Lucrin Pds Depot Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Hungary Astellas Pharma Kft Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Hungary Astellas Pharma Kft Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Hungary Astellas Pharma Kft Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Hungary Sandoz Hungária Kft Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Hungary Sandoz Hungária Kft Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Iceland Astellas Pharma A/S Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Iceland Astellas Pharma A/S Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Iceland Astellas Pharma A/S Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Ireland Gp-Pharm S.A. Leuprorelin 1-Month Depot Gp-Pharm

Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Ireland Gp-Pharm S.A. Leuprorelin 3-Month Depot Gp-Pharm

Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Ireland Mercury Pharmaceuticals Ltd.

Lutrate 1 Month Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Ireland Mercury Pharmaceuticals Ltd.

Lutrate 3 Month Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Ireland Takeda Products Ireland Ltd.

Prostap Sr Dcs Leuprorelin Acetate 3.75mg

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use / Subcutaneous Use

Ireland Takeda Products Ireland Ltd.

Prostap 3 Dcs Leuprorelin Acetate 11.25mg

Powder And Solvent For Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

Ireland Astellas Pharma Co. Ltd.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Ireland Astellas Pharma Co. Ltd.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Ireland Astellas Pharma Co. Ltd.

Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Ireland Rowex Ltd Leuprex 3 Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Ireland Takeda Products Ireland Ltd.

Prostap 6 Dcs Leuprorelin Acetate 30mg

Powder And Solvent For Prolonged-Release Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Italy Sandoz S.P.A. Leptoprol Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Implantation

Italy Sandoz S.P.A. Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Implantation

Italy Gp-Pharm S.A. Politrate Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Italy Gp-Pharm S.A. Politrate Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Italy Takeda Italia S.P.A. Enantone Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use / Subcutaneous Use

Italy Takeda Italia S.P.A. Enantone Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use / Subcutaneous Use

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Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Italy Astellas Pharma S.P.A. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Italy Astellas Pharma S.P.A. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Italy Astellas Pharma S.P.A. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Latvia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Latvia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Latvia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Latvia Sandoz Pharmaceuticals D.D.

Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Lithuania Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Lithuania Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Lithuania Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Lithuania Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Luxembourg Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Luxembourg Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Page 17: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

17

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Luxembourg Astellas Pharma B.V., Office Be

Depo-Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Luxembourg Endomedica Gmbh Leugon Leuprorelin Acetate 11.25mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Netherlands Abbvie B.V. Lucrin Depot Leuprorelin Acetate 11.25mg Vial

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Netherlands Abbvie B.V. Lucrin Depot Leuprorelin Acetate 3.75mg

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Netherlands Abbvie B.V. Lucrin Pds Depot 1 Maand

Leuprorelin Acetate 3.75mg

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Netherlands Abbvie B.V. Lucrin Pds Depot 3 Maanden

Leuprorelin Acetate 11.25mg

Powder And Solvent For Suspension For Injection

Intramuscular Use / Subcutaneous Use

Netherlands Abbvie B.V. Lucrin Pds Depot 6 Maanden

Leuprorelin Acetate 30mg

Powder And Solvent For Suspension For Injection

Subcutaneous Use

Netherlands Astellas Pharma B.V. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Netherlands Astellas Pharma B.V. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Netherlands Astellas Pharma B.V. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Netherlands Sandoz B.V. Leuproreline Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Page 18: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

18

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Netherlands Sandoz B.V. Leuproreline Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Norway Abbvie As Procren Depot Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Norway Abbvie As Procren Depot Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Norway Abbvie As Procren Depot Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Norway Astellas Pharma A/S Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Norway Astellas Pharma A/S Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Norway Astellas Pharma A/S Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Norway Orion Corporation Enanton Depot Dual Leuprorelin Acetate 11.25mg

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Norway Orion Corporation Enanton Depot Dual Leuprorelin Acetate 3.75mg

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Page 19: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

19

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Norway Orion Corporation Enanton Depot Dual Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Norway Sandoz A/S Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Norway Sandoz A/S Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Poland Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Poland Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Poland Abbvie Polska Sp. Z O.O.

Lucrin Depot Leuprorelin Acetate 11.25mg Vial

Suspension For Injection

Intramuscular Use / Subcutaneous Use

Poland Abbvie Polska Sp. Z O.O.

Lucrin Depot Leuprorelin Acetate 3.75mg Vial

Suspension For Injection

Intramuscular Use / Subcutaneous Use

Poland Astellas Pharma Sp.Z.O.O.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Poland Astellas Pharma Sp.Z.O.O.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Poland Astellas Pharma Sp.Z.O.O.

Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Poland Sandoz Gmbh Leuprostin Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Page 20: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

20

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Poland Sandoz Gmbh Leuprostin Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Portugal Gp-Pharm S.A. Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Portugal Gp-Pharm S.A. Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Portugal Astellas Farma Lda. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Portugal Astellas Farma Lda. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Portugal Astellas Farma Lda. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Romania Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Romania Angelini Pharma Österreich Gmbh

Lutrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Romania Astellas Pharma Europe B.V.

Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Romania Astellas Pharma Europe B.V.

Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Page 21: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

21

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Romania S.C. Sandoz S.R.L. Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Slovakia Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovakia Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovakia Astellas Pharma S.R.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovakia Sandoz Pharmaceuticals D.D.

Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Slovakia Sandoz Pharmaceuticals D.D.

Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Slovenia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovenia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovenia Astellas Pharma D.O.O. Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Slovenia Sandoz Pharmaceuticals D.D.

Leptoprol Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Spain Abbvie Spain S.L.U. Ginecrin Depot Leuprorelin 3.75mg Vial Powder And Solvent For Suspension For Injection

Intramuscular Use

Spain Gp-Pharm S.A. Leuprorelina Gp-Pharm Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Page 22: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

22

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Spain Gp-Pharm S.A. Leuprorelina Gp-Pharm Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Spain Gp-Pharm S.A. Lutrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Spain Gp-Pharm S.A. Lutrate Depot Trimestral

Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

Spain Abbvie Spain S.L.U. Procrin Mensual Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Spain Abbvie Spain S.L.U. Procrin Semestral Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Spain Abbvie Spain S.L.U. Procrin Trimestral Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Spain Astellas Pharma S.A. Eligard Mensual Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Spain Astellas Pharma S.A. Eligard Semestral Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Page 23: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

23

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Spain Astellas Pharma S.A. Eligard Trimestral Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Spain Sandoz Farmacéutica, S.A.

Leuprorelina Trimestral Sandoz

Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Sweden Abbvie Ab Procren Depot Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Sweden Abbvie Ab Procren Depot Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Sweden Abbvie Ab Procren Depot Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Sweden Astellas Pharma A/S Eligard Leuprorelin Acetate 22.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Sweden Astellas Pharma A/S Eligard Leuprorelin Acetate 45mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Sweden Astellas Pharma A/S Eligard Leuprorelin Acetate 7.5mg Syringe

Powder And Solvent For Solution For Injection

Subcutaneous Use

Sweden Orion Corporation Enanton Depot Dual Leuprorelin Acetate 11.25mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Sweden Orion Corporation Enanton Depot Dual Leuprorelin Acetate 3.75mg Syringe

Powder And Solvent For Suspension For

Subcutaneous Use

Page 24: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

24

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Injection In Pre-Filled Syringe

Sweden Orion Corporation Enanton Depot Dual Leuprorelin Acetate 30mg Syringe

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Subcutaneous Use

Sweden Sandoz A/S Leuprorelin Sandoz Leuprorelin 3.6mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

Sweden Sandoz A/S Leuprorelin Sandoz Leuprorelin 5mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use

United Kingdom Gp-Pharm S.A. Lutrate 1 Month Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

United Kingdom Gp-Pharm S.A. Lutrate 3 Month Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

United Kingdom Gp-Pharm S.A. Politrate Depot Leuprorelin Acetate 1.875mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

United Kingdom Gp-Pharm S.A. Politrate Depot Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Prolonged-Release Suspension For Injection

Intramuscular Use

United Kingdom Takeda Uk Ltd Prostap 3 Dcs Leuprorelin Acetate 11.25mg/Ml

Powder And Solvent For Suspension For

Intramuscular Use / Subcutaneous Use

Page 25: Annex I List of medicinal products and presentations · List of medicinal products and presentations . 2 Member State EU/EEA Marketing authorisation holder Invented name INN + Strength

25

Member State EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form Route of administration

Injection In Pre-Filled Syringe

United Kingdom Takeda Uk Ltd Prostap Sr Dcs Leuprorelin Acetate 3.75mg/Ml

Powder And Solvent For Suspension For Injection In Pre-Filled Syringe

Intramuscular Use / Subcutaneous Use

United Kingdom Amdeepcha Limited Leuprorelin Amdeepcha Leuprorelin Acetate 11.25mg Implant

Implant In Pre-Filled Syringe

Subcutaneous Use