Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Ebilfumin 30 mg hard capsules.
Ebilfumin 45 mg hard capsules.
Ebilfumin 75 mg hard capsules.
| Pharmaceutical Form |
|---|
Ebilfumin 30 mg hard capsulesThe hard capsule consists of a rich yellow body and cap bearing the black imprint “OS 30”. Capsule size: 4. The capsule contains a white granulated powder. Ebilfumin 45 mg hard capsulesThe hard capsule consists of a white opaque body and cap bearing the black imprint “OS 45”. Capsule size: 4. The capsule contains a white granulated powder. Ebilfumin 75 mg hard capsulesThe hard capsule consists of a white opaque body and a rich yellow cap bearing the black imprint “OS 75”. Capsule size: 2. The capsule contains a white granulated powder. |
Ebilfumin 30 mg hard capsules:
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
For the full list of excipients, see section 6.1.
Ebilfumin 45 mg hard capsules:
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
For the full list of excipients, see section 6.1.
Ebilfumin 75 mg hard capsules:
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Oseltamivir |
Oseltamivir (oseltamivir carboxylate) is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface. Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body. |
| List of Excipients |
|---|
Ebilfumin 30 mg hard capsulesCapsule core: Pregelatinised starch (derived from maize starch) Capsule shell: Gelatin Printing ink: Shellac Glaze-45% (20% esterified) Ebilfumin 45 mg hard capsulesCapsule core: Pregelatinised starch (derived from maize starch) Capsule shell: Gelatin Printing ink: Shellac Glaze-45% (20% esterified) Ebilfumin 75 mg hard capsulesCapsule core: Pregelatinised starch (derived from maize starch) Capsule shell: Cap: Gelatin Body: Gelatin Printing ink Shellac Glaze-45% (20% esterified) |
PVC/PE/PVdC/Al blisters or HDPE containers with LDPE lid (and a desiccant).
Pack-size 10 capsules.
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Ebilfumin 30 mg hard capsules:
EU/1/14/915/001 (10 hard capsules blister)
EU/1/14/915/002 (10 hard capsules container)
Ebilfumin 45 mg hard capsules:
EU/1/14/915/003 (10 hard capsules container)
EU/1/14/915/004 (10 hard capsules blister)
Ebilfumin 75 mg hard capsules:
EU/1/14/915/005 (10 hard capsules blister)
EU/1/14/915/006 (10 hard capsules container)
Date of first authorisation: 22 May 2014
Date of latest renewal: 12 February 2019
| Drug | Countries | |
|---|---|---|
| EBILFUMIN | Austria, Estonia, Spain, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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