Details

Product Name in the RMS: LUTRATE DEPOT 22,5 mg powder and solvent for prolonged release suspension for injection

MR Number: ES/H/0141/002
Date of outcome: 04.05.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Full Dossier Chemical Substance Prescription Only
Active Substances	leuprorelin 22,5 mg
Form	POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
MA Holder in the RMS	GP-PHARM, S.A. Carretera Comarcal C-244, Km 22, 08777 Sant Quintí de Mediona- Barcelona (SPAIN)
RMS	Spain
Date of last change	28.12.2020
ATC-Code	L02AE02 Leuprorelin

CMS Country	Domestic Product Name
Austria	Lutrate 3-Monats-Depot 22,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Bulgaria	Lutrate Depot
Czech Republic	Lutrate Depot 22,5 mg Prášek a rozpouštědlo pro injekční suspenzi s prodlouženým účinkem
Germany	Lutrate Depot 22,5 mg Pulver Und Lösungsmittel zur Herstellung einer Injektionssuspension
Greece	LUTRATE® DEPOT
Hungary	POLITRATE DEPOT 22,5 mg por és oldószer retard szuszpenziós injekcióhoz
Italy
Poland
Portugal
Romania	Lutrate Depot 22,5 mg pulbere şi solvent pentru suspensie injectabilă cu eliberare prelungită

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