Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Talzenna 0.1 mg hard capsules.
Talzenna 0.25 mg hard capsules.
Talzenna 1 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Talzenna 0.1 mg hard capsules: Opaque, approximately 14 mm × 5 mm hard capsule with a white cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black). Talzenna 0.25 mg hard capsules: Opaque, approximately 14 mm × 5 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 mm × 5 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black). |
Talzenna 0.1 mg hard capsules: Each hard capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib.
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 (microcrystalline cellulose and silicone dioxide) 0.1 mg capsule shell: Hypromellose 0.25 mg capsule shell: Hypromellose 1 mg capsule shell: Hypromellose Printing ink: Shellac (E904) |
Talzenna 0.1 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.
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
Date of first authorisation: 20 June 2019
Date of latest renewal: 15 April 2024
| Drug | Countries | |
|---|---|---|
| TALZENNA | Austria, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Nigeria, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
