Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome – Italy
Ontozry 12.5 mg tablets.
Ontozry 25 mg film-coated tablets.
Ontozry 50 mg film-coated tablets.
Ontozry 100 mg film-coated tablets.
Ontozry 150 mg film-coated tablets.
Ontozry 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Ontozry 12.5 mg tablet: Tablet. Ontozry 25 mg, 50 mg, 100 mg, 150 mg and 200 mg film-coated tablet: film-coated tablet. Ontozry 12.5 mg tablet: Uncoated round white to off-white tablet with AV on one side and ‘12’ on the other side. Ontozry 25 mg film-coated tablet: Film-coated round brown tablet with AV on one side and ‘25’ on the other side. Ontozry 50 mg film-coated tablet: Film-coated round yellow tablet with AV on one side and ‘50’ on the other side. Ontozry 100 mg film-coated tablet: Film-coated round brown tablet with AV on one side and ‘100’ on the other side. Ontozry 150 mg film-coated tablet: Film-coated light orange round tablet with AV on one side and ‘150’ on the other side. Ontozry 200 mg film-coated tablet: Film-coated oval, light orange tablet with AV on one side and ‘200’ on the other side. |
Ontozry 12.5 mg tablets: Each tablet contains 12.5 mg cenobamate.
Ontozry 25 mg film-coated tablets: Each film-coated tablet contains 25 mg cenobamate.
Ontozry 50 mg film-coated tablets: Each film-coated tablet contains 50 mg cenobamate.
Ontozry 100 mg film-coated tablets: Each film-coated tablet contains 100 mg cenobamate.
Ontozry 150 mg film-coated tablets: Each film-coated tablet contains 150 mg cenobamate.
Ontozry 200 mg film-coated tablets: Each film-coated tablet contains 200 mg cenobamate.
Excipient with known effect:
Each 12.5 mg tablet contains 39.7 mg lactose monohydrate.
Each 25 mg film-coated tablet contains 79.3 mg lactose monohydrate.
Each 50 mg film-coated tablet contains 158.7 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 108.7 mg lactose monohydrate.
Each 150 mg film-coated tablet contains 163 mg lactose monohydrate.
Each 200 mg film-coated tablet contains 217.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cenobamate |
Cenobamate is a small molecule with a dual mechanism of action. It is a positive allosteric modulator of subtypes of the γ-aminobutyric acid (GABAA) ion channel, that does not bind to the benzodiazepine binding site. Cenobamate has also been shown to reduce repetitive neuronal firing by enhancing the inactivation of sodium channels and by inhibiting the persistent component of the sodium current. |
| List of Excipients |
|---|
|
Tablet and film-coated tablet content: Lactose monohydrate Film-coating: 25 mg and 100 mg film-coated tablets: Indigo carmine aluminium lake (E132) 50 mg film-coated tablets: Iron oxide yellow (E172) 150 mg and 200 mg film-coated tablets: Iron oxide red (E172) |
PVC/aluminium blisters.
Ontozry Treatment Initiation pack 12.5 mg tablets and 25 mg film-coated tablets:
Pack of 14 tablets of 12.5 mg and 14 film-coated tablets of 25 mg.
Ontozry 50 mg film-coated tablets:
50 mg – packs of 14, 28 or 84.
Ontozry 100 mg film-coated tablets:
100 mg – packs of 14, 28 or 84.
Ontozry 150 mg film-coated tablets:
150 mg – packs of 14, 28 or 84.
Ontozry 200 mg film-coated tablets:
200 mg – packs of 14, 28 or 84.
Not all pack sizes may be marketed.
Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome – Italy
EU/1/21/1530/001
EU/1/21/1530/002
EU/1/21/1530/003
EU/1/21/1530/004
EU/1/21/1530/005
EU/1/21/1530/006
EU/1/21/1530/007
EU/1/21/1530/008
EU/1/21/1530/009
EU/1/21/1530/010
EU/1/21/1530/011
EU/1/21/1530/012
EU/1/21/1530/013
Date of first authorisation: 26/03/2021
| Drug | Countries | |
|---|---|---|
| ONTOZRY | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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