ONGENTYS Hard capsule Ref.[9758] Active ingredients: Opicapone

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

Product name and form

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.

Qualitative and quantitative composition

Ongentys 25 mg hard capsules

Each hard capsule contains 25 mg of opicapone.

Excipient(s) with known effect: Each hard capsule contains 171.9 mg of lactose (as monohydrate).

Ongentys 50 mg hard capsules

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
Sodium starch glycolate, Type A
Maize starch, pregelatinized
Magnesium stearate

Capsule shell:

Gelatin
Indigo carmine aluminium lake (E132)
Erythrosine (E127)
Titanium dioxide (E171)

Printing ink:

Ongentys 25 mg hard capsules:

Shellac
Propylene glycol
Ammonia solution, concentrated
Indigo carmine aluminium lake (E132)

Ongentys 50 mg hard capsules:

Shellac
Titanium dioxide (E171)
Propylene glycol
Ammonia solution, concentrated
Simeticone

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/15/1066/001-010

Date of first authorisation: 24 June 2016

Drugs

Drug Countries
ONGENTYS Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.