Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Tamiflu 6 mg/ml powder for oral suspension.
| Pharmaceutical Form |
|---|
|
Powder for oral suspension. The powder is a granulate or clumped granulate with a white to light yellow colour. |
Each ml of reconstituted suspension contains oseltamivir phosphate equivalent to 6 mg of oseltamivir.
One bottle of reconstituted suspension (65 ml) contains 390 mg of oseltamivir.
Excipients with known effect:
5 ml oseltamivir suspension delivers 0.9 g of sorbitol.
7.5 ml oseltamivir suspension delivers 1.3 g of sorbitol.
10 ml oseltamivir suspension delivers 1.7 g of sorbitol.
12.5 ml oseltamivir suspension delivers 2.1 g of sorbitol.
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 |
|---|
|
Sorbitol (E420) |
100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic adapter (low density polyethylene), plastic 3 ml oral dispenser (0.1 ml graduation) and 10 ml oral dispenser (0.5 ml graduation) (barrel and plunger: polypropylene, silicon based seal ring) and a plastic measuring cup (polypropylene).
Pack-size of one bottle.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/02/222/005
Date of first authorisation: 28 November 2011
Date of last renewal: 22 May 2012
| Drug | Countries | |
|---|---|---|
| TAMIFLU | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa |
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