1
Annex I
List of medicinal products and presentations
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
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
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
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
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
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
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
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
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
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