Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Oncopeptides AB (publ), Luntmakargatan 46, 111 37 Stockholm, Sweden
Pepaxti 20 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). Lyophilised white to off-white powder. |
One vial of powder contains 20 mg melphalan flufenamide (as hydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Melphalan |
Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-2-chloroethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine on DNA, cross-linking the two DNA strands and thereby preventing cell replication. |
| List of Excipients |
|---|
|
Sucrose |
50 mL Type 1 glass vial sealed with chlorobutyl rubber stopper and aluminium overseal with a plastic removable cap containing 20 mg powder. Pack size of 1 vial.
Oncopeptides AB (publ), Luntmakargatan 46, 111 37 Stockholm, Sweden
EU/1/22/1669/001
Date of first authorisation: 17 August 2022
| Drug | Countries | |
|---|---|---|
| PEPAXTI | Austria, Estonia, Croatia, Ireland, Italy, Lithuania |
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