Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Akeega 50 mg/500 mg film-coated tablets.
Akeega 100 mg/500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Akeega 50 mg/500 mg film-coated tablets: Yellowish orange to yellowish brown, oval, film-coated tablets (22 mm x 11 mm), debossed with “N 50 A” on one side, and plain on the other side. Akeega 100 mg/500 mg film-coated tablets: Orange, oval, film-coated tablets (22 mm x 11 mm), debossed with “N 100 A” on one side, and plain on the other side. |
Akeega 50 mg/500 mg film-coated tablets: Each film-coated tablet contains niraparib tosylate monohydrate equivalent to 50 mg of niraparib and 500 mg of abiraterone acetate equivalent to 446 mg of abiraterone.
Akeega 100 mg/500 mg film-coated tablets: Each film-coated tablet contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib and 500 mg of abiraterone acetate equivalent to 446 mg of abiraterone.
Excipients with known effect: Each film-coated tablet contains 241 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abiraterone |
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals. |
|
| Niraparib |
Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. |
| List of Excipients |
|---|
Akeega 50 mg/500 mg film-coated tabletsTablet core: Colloidal anhydrous silica Film-coating: Iron oxide black (E172) Akeega 100 mg/500 mg film-coated tabletsTablet core: Colloidal anhydrous silica Film-coating: Iron oxide red (E172) |
Each 28-day carton contains 56 film-coated tablets in two cardboard wallet packs each containing 28 film-coated tablets in a PVdC/PE/PVC blister with an aluminum push-through foil.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/23/1722/001
EU/1/23/1722/002
| Drug | Countries | |
|---|---|---|
| AKEEGA | Austria, France, Croatia, Lithuania |
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