Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Rozlytrek 100 mg hard capsules.
Rozlytrek 200 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Rozlytrek 100 mg hard capsules: Size 2 (18 mm in length), hard capsule with yellow opaque body and cap with ENT 100 imprinted in blue on the body. Rozlytrek 200 mg hard capsules: Size 0 (21.7 mm in length), hard capsule with orange opaque body and cap with ENT 200 imprinted in blue on the body. |
Each hard capsule contains 100 mg of entrectinib.
Excipients with known effect: Each hard capsule contains 65 mg lactose.
Each hard capsule contains 200 mg of entrectinib.
Excipients with known effect: Each hard capsule contains 130 mg lactose, and 0.6 mg of the azo colouring agent sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Entrectinib |
Entrectinib is an inhibitor of the tropomyosin receptor tyrosine kinases TRKA, TRKB and TRKC (encoded by the neurotrophic tyrosine receptor kinase [NTRK] genes NTRK1, NTRK2 and NTRK3, respectively), proto-oncogene tyrosine-protein kinase ROS (ROS1), and anaplastic lymphoma kinase (ALK). Entrectinib demonstrated in vitro and in vivo inhibition of cancer cell lines derived from multiple tumour types, including subcutaneous and intracranial tumours, harbouring NTRK, ROS1, and ALK fusion genes. |
| List of Excipients |
|---|
|
Capsule content: Tartaric acid (E334) Capsule shell: Hypromellose (E464) Printing ink: Shellac (E904) |
Rozlytrek 100 mg hard capsules:
HDPE bottles containing 30 hard capsules with a child-resistant, tamper-evident closure and silica gel desiccant integrated in the cap.
Rozlytrek 200 mg hard capsules:
HDPE bottles containing 90 hard capsules with a child-resistant, tamper-evident closure and silica gel desiccant integrated in the cap.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/20/1460/001
EU/1/20/1460/002
Date of first authorisation: 31 July 2020
Date of latest renewal: 7 July 2023
| Drug | Countries | |
|---|---|---|
| ROZLYTREK | Austria, Australia, Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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