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	27.10.2018
ATC-Code	L02AE02 Leuprorelin

CMS Country	Domestic Product Name
Austria	Lutrate Depot 22,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
Belgium	Lutrate Depot 22.5 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
Bulgaria	Lutrate Depot
Czech Republic	Lutrate Depot 22,5 mg Prášek a rozpouštědlo pro injekční suspenzi s prodlouženým účinkem
Denmark	Lutrate Depot
Estonia
Finland
Germany	Lutrate Depot 22,5 mg Pulver Und Lösungsmittel zur Herstellung einer Injektionssuspension
Greece	LUTRATE® DEPOT
Hungary	Lutrate Depot 3,75mg por és oldószer szuszpenziós injekcióhoz
Ireland
Italy
Latvia	Lutrate Depot 22,5 mg pulveris un šķīdinātājs ilgstošas darbības injekciju suspensijas pagatavošanai
Lithuania	Lutrate Depot 22,5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai
Netherlands	Leuproreline 22,5 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
Norway
Poland
Portugal
Romania	Lutrate Depot 3.75 mg pulbere şi solvent pentru suspensie injectabilă
Slovak Republic	Lutrate Depot 22,5 mg prášok a disperzné prostredie na injekčnú suspenziu s predĺženým uvoľňovaním
Sweden
United Kingdom

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