Details

Product Name in the RMS: Xalmono 0,05 mg/ml ey drops solution in unit dose container

MR Number: NL/H/3193/001
Date of outcome: 27.11.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Multiple (Copy) Application Other Chemical Substance Prescription Only
Active Substances	latanoprost 0,05 mg/ml
Form	Eye drops, solution
MA Holder in the RMS	Genetic S.p.A., Via G. Della Monica, 26 8 4083 Castel San Giorgio (SA), Italy
RMS	Netherlands
Date of last change	20.08.2020
ATC-Code	S01EE01 Latanoprost

CMS Country	Domestic Product Name
Poland	Xaloptic Free

Documents
PAR:	NL_H_3193_001_PAR.pdf (26.10.2017)
PARSummary:	NL_H_3193_001_PARSummary.pdf (17.03.2015)
FinalSPC:	NL_H_3193_001_FinalSPC.pdf (25.01.2018)
FinalPL:	NL_H_3193_001_FinalPL.pdf (25.01.2018)
FinalLabelling:	NL_H_3193_001_FinalLabelling.pdf (23.11.2018)
Finalised Product Information:	NL_H_3193_001_FinalPI.pdf (27.11.2014)