Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: MYLAN S.A.S, 117 Allée des Parcs, 69800 Saint-Priest, France
Tenofovir disoproxil Mylan 245 mg film-coated tablets.
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Film-coated tablet. Light blue, round, biconvex, film-coated tablets, 12.20 ± 0.20 mm in diameter, debossed with ‘TN245’ on one side and ‘M’ on other side. |
Each film-coated tablet contains 245 mg of tenofovir disoproxil (corresponding to 300 mg of tenofovir disoproxil maleate).
Excipient with known effect: Each tablet contains 155 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| List of Excipients |
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Tablet core: Microcrystalline cellulose Film-coating: Hypromellose |
High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure with wad containing aluminium induction sealing liner and desiccant (silica gel), available in the following pack sizes: 30 film-coated tablets and multipacks containing 90 (3 packs of 30) film-coated tablets.
OPA/Aluminium/PE/Desiccant/PE-Aluminium blister packs containing 10 or 30 film coated tablets. OPA/Aluminium/PE/Desiccant/PE-Aluminium perforated unit dose blister pack containing 30 × 1 film-coated tablets.
Not all pack sizes may be marketed.
MYLAN S.A.S, 117 Allée des Parcs, 69800 Saint-Priest, France
EU/1/16/1129/001
EU/1/16/1129/002
EU/1/16/1129/003
EU/1/16/1129/004
EU/1/16/1129/005
Date of first authorisation: 08 December 2016
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