Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Inceptua AB, Gustavslundsv. 143, 16751 Bromma, Sweden
Apealea 60 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. Greenish-yellow to yellow powder. |
One vial of powder contains 60 mg of paclitaxel.
After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar).
Excipients with known effect: Each vial contains 3.77 mg (0.164 mmol) sodium. After reconstitution, each mL of solution contains up to approximately 3.60 mg (0.157 mmol) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paclitaxel |
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. |
| List of Excipients |
|---|
|
N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt |
Clear type I glass vial with a silicon coated butyl rubber stopper, an aluminium overseal and a plastic flip-off cap containing powder equivalent to 60 mg of paclitaxel.
Pack size: 1 vial.
Inceptua AB, Gustavslundsv. 143, 16751 Bromma, Sweden
EU/1/18/1292/001
Date of first authorisation: 20 November 2018
| Drug | Countries | |
|---|---|---|
| APEALEA | Austria, Estonia, Finland, Croatia, Ireland, Lithuania, Poland |
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