Details

Product Name in the RMS: Mydrane

MR Number: DK/H/2439/001
Date of outcome: 02.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only
Active Substances	lidocaine hydrochloride 10 mg/ml phenylephrine hydrochloride 3,1 mg/ml tropicamide 0,2 mg/ml
Form	Solution for injection
MA Holder in the RMS	Former RMS: SE/H/1351/001/DC Laboratoires Thea 12, rue Louis Bleriot 63017 Clermont-Ferrand Cedex 2 France Change of RMS during validation, former RMS SE/H/1351/001/DC
RMS	Denmark
Date of last change	12.11.2020
ATC-Code	S01FA56 Tropicamide, combinations

CMS Country	Domestic Product Name
Austria
Belgium	Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml, solution Injectable
Bulgaria	Mydrane
Croatia	Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml otopina za injekciju
Cyprus	MYDRANE SOL FOR INJECTION
Czech Republic	Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml
Finland
France
Germany	Mydrane
Greece	MYDRANE
Iceland	MYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml Stungulyf, lausn
Ireland
Italy
Luxembourg
Netherlands	MYDRANE 10/3.1/0.2 mg/ml, oplossing voor injectie
Norway
Poland	Mydrane
Portugal
Romania	MYDRANE 0,2 mg/ml+3,1 mg/ml+10 mg/ml soluție injectabilă
Slovak Republic	MYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml injekčný roztok
Slovenia
Spain
Sweden	MYDRANE
United Kingdom

Documents
PAR:	DK_H_2439_001_PAR.pdf (14.12.2015)
PARSummary:	DK_H_2439_001_PARSummary.pdf (14.12.2015)
FinalSPC:	DK_H_2439_001_FinalSPC.pdf (13.06.2019)
FinalPL:	DK_H_2439_001_FinalPL.pdf (13.06.2019)
FinalLabelling:	DK_H_2439_001_FinalLabelling.pdf (27.03.2018)
Finalised Product Information:	DK_H_2439_001_FinalPI_1of3.pdf (07.05.2018)
Finalised Product Information:	DK_H_2439_001_FinalPI_2of3.pdf (07.05.2018)
Finalised Product Information:	DK_H_2439_001_FinalPI_3of3.pdf (07.05.2018)