Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, Dublin 24, Ireland
Lexotan 1.5 mg Tablets.
Lexotan 3 mg Tablets.
| Pharmaceutical Form |
|---|
Lexotan 1.5 mg TabletsTablet. Off-white to slightly yellow, cylindrical, biplane tablets scored on one side and marked Roche 1.5 on reverse. Lexotan 3 mg TabletsTablet. Pale red, slightly speckled, cylindrical, biplane tablets scored on one side and marked Roche 3 on reverse. The tablets can be divided into equal doses. |
Each tablet contains 1.5 mg bromazepam.
Excipients: Also contains 96.1 mg lactose monohydrate.
Each tablet contains 3 mg bromazepam.
Excipients: Also contains 94.4 mg lactose monohydrate.
Excipient(s) with known effect: For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties. |
| List of Excipients |
|---|
|
Lexotan 1.5 mg Tablets: Microcrystalline cellulose Lexotan 3 mg Tablets: Microcrystalline cellulose |
PVDC blister packs of 4, 10, 20, 60 or 100 tablets.
HDPE bottles of 100 tablets.
PVC blister packs of 30 tablets.
Not all pack sizes may be marketed.
Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, Dublin 24, Ireland
Lexotan 1.5 mg Tablets: PA 2307/003/001
Lexotan 3 mg Tablets: PA 2307/003/002
Date of first authorisation: 31 October 1980
Date of last renewal: 31 October 2010
| Drug | Countries | |
|---|---|---|
| LEXOTAN | Australia, Brazil, Ecuador, Hong Kong, Ireland, Japan, Malta, Mexico, Poland, Singapore, South Africa |
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