Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Talzenna 0.25 mg hard capsules.
Talzenna 1 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Talzenna 0.25 mg hard capsules: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black). Talzenna 1 mg hard capsules: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black). |
Talzenna 0.25 mg hard capsules: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Talzenna 1 mg hard capsules: Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Talazoparib |
Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2. PARP enzymes are involved in cellular DNA damage response signalling pathways such as DNA repair, gene transcription, and cell death. PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, thereby resulting in apoptosis and/or cell death. |
| List of Excipients |
|---|
|
Capsule content: Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 0.25 mg capsule shell: Hypromellose (HPMC) 1 mg capsule shell: Hypromellose (HPMC) Printing ink: Shellac (E904) |
Talzenna 0.25 mg hard capsules:
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner. Pack size: cartons of 30 capsules in a HDPE bottle.
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding. Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters.
Talzenna 1 mg hard capsules:
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner. Pack size: cartons of 30 capsules in a HDPE bottle.
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding. Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Talzenna 0.25 mg hard capsules:
EU/1/19/1377/001
EU/1/19/1377/002
EU/1/19/1377/003
EU/1/19/1377/004
Talzenna 1 mg hard capsules:
EU/1/19/1377/005
EU/1/19/1377/006
| Drug | Countries | |
|---|---|---|
| TALZENNA | Austria, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Nigeria, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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