Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
GAVRETO 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Light blue, opaque hard capsule, size 0 (22 mm long x 7 mm wide) with “BLU-667” printed on the capsule shell body and “100 mg” on the capsule shell cap in white ink. |
Each hard capsule contains 100 mg of pralsetinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pralsetinib |
Pralsetinib is a potent protein kinase inhibitor that selectively targets oncogenic RET fusions (KIF5BRET and CCDC6-RET). In non-small cell lung cancer (NSCLC), RET fusions are one of the main oncogenic drivers. |
| List of Excipients |
|---|
|
Capsule content: Hypromellose Capsule shell: Brilliant blue FCF (E133) Printing ink: Shellac |
High density polyethylene (HDPE) bottle with child-resistant closure (polypropylene) and foiled induction seal liner and desiccant sachet (silica gel).
Pack sizes: 60, 90 or 120 capsules.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/21/1555/001
EU/1/21/1555/002
EU/1/21/1555/003
Date of first authorisation: 18 November 2021
| Drug | Countries | |
|---|---|---|
| GAVRETO | Austria, Ecuador, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United States |
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