Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, Netherlands
Fetcroja 1 g powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder. |
Each vial contains cefiderocol sulfate tosylate equivalent to 1 g of cefiderocol.
Excipient with known effect: Each vial contains 7.64 mmol of sodium (approximately 176 mg).
For the full list of excipients, see section 6.1.
| List of Excipients |
|---|
|
Sucrose |
14 mL vial (Type I clear glass vial), chlorobutyl elastomeric stopper, and aluminum seal with a plastic flip-off cap. The vials are packed in a cardboard carton.
Pack size of 10 vials.
Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, Netherlands
EU/1/20/1434/001
Date of first authorisation: 23 april 2020
| Drug | Countries | |
|---|---|---|
| FETCROJA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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