Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Linezolid 600 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, ovaloid tablet debossed with “LZD” on one side and “600” on the other. |
Each tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Linezolid |
Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones. It has in vitro activity against aerobic Gram-positive bacteria and anaerobic micro-organisms. Linezolid selectively inhibits bacterial protein synthesis via a unique mechanism of action. |
| List of Excipients |
|---|
|
Tablet core: Maize starch (corn derived) Film coat: Opadry, white, YS-1-18202-A(e) comprising: Hypromellose (E464) |
White, HDPE bottle with a polypropylene screw cap containing either 10*, 14*, 20*, 24, 30, 50 or 60 tablets.
White, HDPE bottle with a polypropylene screw cap containing 100 tablets (for hospital use only).
Note:
*The above bottles may also be supplied in “hospital packs” of 5 or 10.
Polyvinylchloride (PVC)/foil blisters of 10 tablets packaged in a box.
Pack sizes: 10*, 20*, 30, 50 or 60 tablets.
Polyvinylchloride (PVC)/foil blisters of 10 tablets packaged in a box.
Pack sizes: 100 tablets (for hospital use only).
Note:
*The above boxes may also be supplied in “hospital packs” of 5 or 10.
Not all package sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1419
Date of first authorisation: 23/11/2012
Date of last renewal: 22/02/2018
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