Latest hum. ProductsDetails
Product Name in the RMS: Gliclazide Actavis
MR Number: DK/H/2376/001
Date of outcome: 24.03.2015
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
| Active Substances |
gliclazide 30 mg |
| Form | Modified release tablet |
| MA Holder in the RMS |
Splitting procedure: New split procedure number is UK/H/6899/001 (IE, UK) Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður, Iceland |
| RMS | Denmark |
| Date of last change | 28.09.2018 |
| ATC-Code |
A10BB09 Gliclazide |
| CMS Country | Domestic Product Name |
|---|---|
| Cyprus | AZILDOR 30MG |
| Czech Republic | GLIKLAZID ACTAVIS 30 MG |
| Estonia | GLICLAZIDE ACTAVIS |
| Greece | GLICLAZIDE/ACTAVIS |
| Ireland | |
| Lithuania | |
| Malta | Azildor |
| Romania | |
| United Kingdom |
| Documents | |
|---|---|
| PAR: | DK_H_2376_001_PAR.pdf (22.08.2016) |
| PARSummary: | DK_H_2376_001_PARSummary.pdf (22.08.2016) |
| FinalSPC: | http://mri.medagencies.org/download/DK_H_2376_001_FinalSPC.pdf (24.03.2015) |
| Finalised Product Information: | DK_H_2376_001_FinalPI.pdf (29.08.2018) |
