Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Deciphera Pharmaceuticals (Netherlands) B.V., Atrium Building 4th Floor, Strawinskylaan 3051, 1077 ZX, Amsterdam, Netherlands
ROMVIMZA 14 mg hard capsules.
ROMVIMZA 20 mg hard capsules.
ROMVIMZA 30 mg hard capsules.
| Pharmaceutical Form |
|---|
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Hard capsule. ROMVIMZA 14 mg hard capsules: The capsule is an orange opaque cap/white opaque body hard capsule of size 4 (approximate length 14 mm), imprinted with "DCV14" in black ink. ROMVIMZA 20 mg hard capsules: The capsule is a yellow opaque cap/white opaque body hard capsule of size 2 (approximate length 18 mm), imprinted with "DCV20" in black ink. ROMVIMZA 30 mg hard capsules: The capsule is a light blue opaque cap/white opaque body hard capsule of size 1 (approximate length 19 mm), imprinted with "DCV30" in black ink. |
Each hard capsule contains 14 mg of vimseltinib (as dihydrate).
Excipients with known effect: Each hard capsule contains 121.32 mg of lactose monohydrate and 0.0855 mg of the azo colouring agent sunset yellow FCF (E110).
Each hard capsule contains 20 mg of vimseltinib (as dihydrate).
Excipients with known effect: Each hard capsule contains 173.32 mg of lactose monohydrate and 0.0075 mg of the azo colouring agent sunset yellow FCF (E110) and 0.0023 mg tartrazine (E102).
Each hard capsule contains 30 mg of vimseltinib (as dihydrate).
Excipient with known effect: Each hard capsule contains 259.98 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Vimseltinib is a selective small molecule tyrosine kinase inhibitor that targets colony stimulating factor 1 receptor (CSF1R). The CSF1/CSF1R signalling axis has a critical role in the development of tenosynovial giant cell tumour (TGCT). |
| List of Excipients |
|---|
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Capsule content: Lactose monohydrate Capsule shell: Gelatin Printing ink: Shellac (E904) |
oPA/Aluminium foil/PVC-film blister with push-through aluminium foil lidding sealed into a child-resistant cardboard wallet pack containing 8 hard capsules.
One carton contains one wallet.
Deciphera Pharmaceuticals (Netherlands) B.V., Atrium Building 4th Floor, Strawinskylaan 3051, 1077 ZX, Amsterdam, Netherlands
EU/1/25/1968/001
EU/1/25/1968/002
EU/1/25/1968/003
| Drug | Countries | |
|---|---|---|
| ROMVIMZA | United States |
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