Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bial Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal Tel:+351 22 986 61 00 Fax: +351 22 986 61 90 e-mail: info@bial.com
Ongentys 25 mg hard capsules.
Ongentys 50 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Ongentys 25 mg hard capsules: Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body. Ongentys 50 mg hard capsules: Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body. |
Each hard capsule contains 25 mg of opicapone.
Excipient(s) with known effect: Each hard capsule contains 171.9 mg of lactose (as monohydrate).
Each hard capsule contains 50 mg of opicapone.
Excipient(s) with known effect: Each hard capsule contains 148.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Opicapone |
Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar). Opicapone is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease, leading to an increase of levodopa plasma levels thereby improving the clinical response to levodopa. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell: Gelatin Printing ink: Ongentys 25 mg hard capsules: Shellac Ongentys 50 mg hard capsules: Shellac |
Ongentys 25 mg hard capsules:
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules.
OPA/Al/PVC//Al blisters containing 10 or 30 capsules.
Ongentys 50 mg hard capsules:
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules
Not all pack sizes may be marketed.
Bial – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
Tel:+351 22 986 61 00
Fax: +351 22 986 61 90
e-mail: info@bial.com
EU/1/15/1066/001-010
Date of first authorisation: 24 June 2016
| Drug | Countries | |
|---|---|---|
| ONGENTYS | Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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