Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SIGA Technologies Netherlands B.V., Prinsenhil 29, Breda 4825 AX, The Netherlands
Tecovirimat SIGA 200 mg hard capsules.
| Pharmaceutical Form |
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Hard capsule (capsule). Opaque gelatin capsules with an orange body and black cap, containing white to off-white powder. The body is printed with “SIGA” and the SIGA logo (a curved triangle with letters in it) followed by " |
Each hard capsule contains tecovirimat monohydrate equivalent to 200 mg tecovirimat.
Excipient(s) with known effect: Each capsule contains 31.5 mg lactose (as monohydrate) and 0.41 mg sunset yellow (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tecovirimat |
Tecovirimat is an antiviral drug against variola (smallpox) virus. Tecovirimat inhibits the activity of the orthopoxvirus VP37 protein, which is encoded by a highly conserved gene in all members of the orthopoxvirus genus. Tecovirimat blocks the interaction of VP37 with cellular Rab9 GTPase and TIP47, which prevents the formation of egress competent enveloped virions necessary for cell-to-cell and long-range dissemination of virus. |
| List of Excipients |
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Capsule content: Silica, hydrophobic colloidal Capsule shell: Gelatin Printing ink: Shellac (E904) |
High-density polyethylene (HDPE) bottles with a polypropylene child-resistant cap.
Pack-size of 84 (2 bottles of 42) hard capsules.
SIGA Technologies Netherlands B.V., Prinsenhil 29, Breda 4825 AX, The Netherlands
EU/1/21/1600/001
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" in white ink. The cap is printed with “ST-246” in white ink. The capsules are 21.7 millimeters long and 7.64 millimeters in diameter.