Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Dovprela 200 mg tablet.
| Pharmaceutical Form |
|---|
|
Tablets. White to off-white oval tablet debossed with M on one side and P200 on the other side. Tablet dimensions: 18 × 9 mm. |
Each tablet contains 200 mg pretomanid.
Excipient with known effect: Each tablet contains 294 mg lactose (as monohydrate) and 5 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pretomanid |
The mechanism of action of pretomanid is thought to involve inhibition of the synthesis of cell wall lipids under aerobic conditions and generation of reactive nitrogen species under anaerobic conditions. Reductive activation of pretomanid by a mycobacterial deazaflavin (F420)-dependent nitro-reductase is required for activity under both aerobic and anaerobic conditions. |
| List of Excipients |
|---|
|
Lactose monohydrate |
High-density polyethylene (HDPE) bottles with polypropylene screw cap with a pulp liner and an absorbent cotton or an ullage filler.
Pack size: 26 tablets.
PVC/PVdC-Aluminium foil blisters packs.
Pack sizes: 14, 14 × 1 (unit dose), 182, 182 × 1 (unit dose) tablets.
Not all pack sizes may be marketed.
Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
EU/1/20/1437/001
EU/1/20/1437/002
EU/1/20/1437/003
EU/1/20/1437/004
EU/1/20/1437/005
Date of first authorisation: 31 July 2020
Date of latest renewal: 23 June 2023
| Drug | Countries | |
|---|---|---|
| DOVPRELA | Estonia, France, Croatia, Italy, Lithuania, Poland |
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