Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Epibal 25 mg hard capsules.
Epibal 50 mg hard capsules.
Epibal 75 mg hard capsules.
Epibal 150 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsules. Epibal 25 mg hard capsules: Hard capsules, size 4, with a white cap and a white body, with “25” printed in black ink on the body. The capsules contain a white to off-white powder. Epibal 50 mg hard capsules: Hard capsules, size 3, with a white cap and a pinkish-orange body, with “50” printed in black ink on the body. The capsules contain a white to off-white powder. Epibal 75 mg hard capsules: Hard capsules, size 4, with a brownish-red cap and a white body, with “75” printed in black ink on the body. The capsules contain a white to off-white powder. Epibal 150 mg hard capsules: Hard capsules, size 2, with a white cap and a white body, with “150” printed in black ink on the body. The capsules contain a white to off-white powder. |
Epibal 25 mg hard capsules: Each hard capsule contains 25 mg of pregabalin.
Epibal 50 mg hard capsules: Each hard capsule contains 50 mg of pregabalin.
Epibal 75 mg hard capsules: Each hard capsule contains 75 mg of pregabalin.
Epibal 150 mg hard capsules: Each hard capsule contains 150 mg of pregabalin.
Excipients with known effect:
Epibal 25 mg hard capsules: Each hard capsule also contains 35 mg lactose monohydrate.
Epibal 50 mg hard capsules: Each hard capsule also contains 70 mg lactose monohydrate.
Epibal 75 mg hard capsules: Each hard capsule also contains 8.25 mg lactose monohydrate.
Epibal 150 mg hard capsules: Each hard capsule also contains 16.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pregabalin |
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system. |
| List of Excipients |
|---|
|
Capsule content: Maize starch Capsule shell: Titanium dioxide (E171) Printing ink: Black iron oxide |
PVC/Aluminium blisters containing 14, 21, 56, 70 (only for 75 mg), 84 or 100 hard capsules.
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
M.L.: 022805 (25MG)
M.L.: 022806 (50MG)
M.L.: 022807 (75MG)
M.L.: 022808 (150MG)
Date of first authorisation: 25 May 2018 / 03/10/2022
| Drug | Countries | |
|---|---|---|
| EPIBAL | Cyprus, Malta |
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