Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Tomel 25 mg film-coated tablets.
Tomel 100 mg film-coated tablets.
Tomel 150 mg film-coated tablets.
Tomel 200 mg film-coated tablets.
Tomel 300 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablets. For 25 mg strength: Peach coloured, round, biconvex film-coated tablets. For 100 mg strength: Yellow coloured, round, biconvex film-coated tablets with breakline on one side*. For 150 mg strength: Pale yellow coloured, round, biconvex film-coated tablets. For 200 mg strength: White, round, biconvex film-coated tablets. For 300 mg strength: White, capsule shaped, film-coated tablets with breakline on one side*. The tablet can be divided into equal doses*. |
Each tablet contains 25 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 1.000 mg lactose monohydrate.
Each tablet contains 100 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 4.000 mg lactose monohydrate.
Each tablet contains 150 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 6.000 mg lactose monohydrate.
Each tablet contains 200 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 8.000 mg lactose monohydrate.
Each tablet contains 300 mg quetiapine (as quetiapine fumarate).
Excipient(s) with known effect: Each tablet contains 12.000 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Quetiapine |
Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors. |
| List of Excipients |
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Tablet core: Calcium hydrogen phosphate anhydrous Film-coating: For 25 mg strength: Opadry 03B84929 Pink (hypromellose, titanium dioxide, macrogol 400, iron oxide yellow, iron oxide red). For 100 mg strength: Opadry 03B82923 Yellow (hypromellose, titanium dioxide, macrogol 400, iron oxide yellow). For 150 mg strength: Opadry 03B82929 Yellow (hypromellose, titanium dioxide, macrogol 400, iron oxide yellow). For 200 mg strength: Opadry Y-1-7000 White (hypromellose, titanium dioxide, macrogol 400). For 300 mg strength: Opadry Y-1-7000 White (hypromellose, titanium dioxide, macrogol 400). |
The tablets for Tomel 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets are packed in white opaque PVC/PE/PVDC/Al blisters containing 28, 30, 60 tablets.
Not all pack sizes may be marketed.
Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Tomel 25 mg film-coated tablets: 021144
Tomel 100 mg film-coated tablets: 021145
Tomel 150 mg film-coated tablets: 021146
Tomel 200 mg film-coated tablets: 021147
Tomel 300 mg film-coated tablets: 021148
Date of first authorization: 10/11/2011
Date of latest renewal: 04/05/2017
| Drug | Countries | |
|---|---|---|
| TOMEL | Cyprus |
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