Latest hum. ProductsDetails
Product Name in the RMS: Daivobet
MR Number: DK/H/0279/002
Date of outcome: 15.08.2008
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Line Extension Initial Application Fixed Combination Chemical Substance Prescription Only |
| Active Substances |
betamethasone dipropionate 0.5 mg/g calcipotriol hydrate 50 µg/g |
| Form | Gel |
| MA Holder in the RMS |
LEO Pharma A/S Industriparken 55 2750 Ballerup Denmark |
| RMS | Denmark |
| Date of last change | 14.03.2013 |
| ATC-Code |
D07XC01 Betamethasone |
| CMS Country | Domestic Product Name |
|---|---|
| Austria | Daivobet 50 Mikrogramm/g + 0,5 mg/g Gel |
| Belgium | |
| Bulgaria | Divobet gel |
| Cyprus | |
| Czech Republic | Daivobet® |
| Estonia | |
| Finland | Daivobet |
| France | |
| Germany | Daivobet Kopfhaut - Gel 50 Mikrogramm / g + 0,5 mg/ g |
| Greece | |
| Hungary | Daivobet 50mcg/g + 5mg/g gél |
| Iceland | |
| Ireland | |
| Italy | |
| Latvia | |
| Lithuania | |
| Luxembourg | |
| Malta | Daivobet® gel |
| Netherlands | |
| Norway | |
| Poland | |
| Portugal | |
| Romania | Daivobet® 50 micrograme/0,5 mg/g gel |
| Slovak Republic | |
| Slovenia | |
| Spain | |
| Sweden | Daivobet |
| United Kingdom |
| Documents | |
|---|---|
| PAR: | http://www.hma.eu/fileadmin/dateien/pipar/dk279daivobet/parmod5_dk279daivobet.pdf (30.03.2009) |
| FinalSPC: | http://mri.medagencies.org/download/DK_H_0279_002_FinalSPC.pdf (21.02.2012) |
| FinalPL: | http://mri.medagencies.org/download/DK_H_0279_002_FinalPL.pdf (21.02.2012) |
| FinalLabelling: | http://www.hma.eu/fileadmin/dateien/pipar/dk279daivobet/pllab_dk279daivobet.pdf (30.03.2009) |
