TAMIFLU Hard capsule Ref.[7015] Active ingredients: Oseltamivir

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Product name and form

Tamiflu 30 mg hard capsules.

Tamiflu 45 mg hard capsules.

Tamiflu 75 mg hard capsules.

Pharmaceutical Form

Tamiflu 30 mg hard capsules: The hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue.

Tamiflu 45 mg hard capsules: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue.

Tamiflu 75 mg hard capsules: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”. Imprints are blue.

Qualitative and quantitative composition

Tamiflu 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.

Tamiflu 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.

Tamiflu 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

Tamiflu 30 mg hard capsules

Capsule core:

Pregelatinised starch (derived from maize starch)
Talc
Povidone
Croscarmellose sodium
Sodium stearyl fumarate

Capsule shell:

Gelatin
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Titanium dioxide (E171)
FD and C Blue 2 (indigo carmine, E132)

Tamiflu 45 mg hard capsules

Capsule core:

Pregelatinised starch (derived from maize starch)
Talc
Povidone
Croscarmellose sodium
Sodium stearyl fumarate

Capsule shell:

Gelatin
Black iron oxide (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Titanium dioxide (E171)
FD and C Blue 2 (indigo carmine, E132)

Tamiflu 75 mg hard capsules

Capsule core:

Pregelatinised starch (derived from maize starch)
Talc
Povidone
Croscarmellose sodium
Sodium stearyl fumarate

Capsule shell:

Gelatin
Yellow iron oxide (E172)
Red iron oxide (E172)
Black iron oxide (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Titanium dioxide (E171)
FD and C Blue 2 (indigo carmine, E132)

Pack sizes and marketing

Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil). Pack-size 10 capsules.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

Tamiflu 30 mg hard capsules: EU/1/02/222/003
Tamiflu 45 mg hard capsules: EU/1/02/222/004
Tamiflu 75 mg hard capsules: EU/1/02/222/001

Date of first authorisation: 20 June 2002
Date of last renewal: 22 May 2012

Drugs

Drug Countries
TAMIFLU Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa

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