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 |
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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 | |
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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) |