Details
Product Name in the RMS: Pregabalin 25 mg capsules, hard
MR Number: NL/H/3245/005
Date of outcome: 26.05.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
pregabalin 25 mg |
Form | Capsule, hard |
MA Holder in the RMS |
G.L. Pharma GmbH Schlossplatz 1 8502 Lannach, Austria |
RMS | Netherlands |
Date of last change | 15.10.2020 |
ATC-Code |
N03AX16 Pregabalin |
CMS Country | Domestic Product Name |
---|---|
Austria | Pregamid 25 mg-Hartkapseln |
Czech Republic | Pregamid 150 mg tvrdé tobolky |
Estonia | PREGAMID |
Hungary | PREGAMID 150 mg kemény kapszula |
Latvia | Pregamid 150 mg cietās kapsulas |
Lithuania | Pregamid 150 mg kietosios kapsulės |
Poland | Pregamid |
Romania | Pregamid 150 mg capsule |
Slovak Republic | Pregamid 25 mg tvrdé kapsuly |
Documents | |
---|---|
PAR: | NL_H_3245_005_PAR.pdf (27.07.2016) |
PARSummary: | NL_H_3245_005_PARSummary.pdf (27.07.2016) |
FinalSPC: | NL_H_3245_005_FinalSPC.pdf (27.05.2015) |
FinalPL: | NL_H_3245_005_FinalPL.pdf (27.05.2015) |
FinalLabelling: | NL_H_3245_005_FinalLabelling.pdf (27.05.2015) |