Latest hum. ProductsDetails
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 | 14.09.2018 |
| 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 |
| 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_1of2.pdf (27.03.2018) |
| FinalSPC: | DK_H_2439_001_FinalSPC_2of2.pdf (27.03.2018) |
| FinalPL: | DK_H_2439_001_FinalPL.pdf (29.09.2017) |
| 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) |
