TENOFOVIR DISOPROXIL MYLAN Film-coated tablet Ref.[7451] Active ingredients:

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: MYLAN S.A.S, 117 Allée des Parcs, 69800 Saint-Priest, France

Product name and form

Tenofovir disoproxil Mylan 245 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Hydroxypropylcellulose, low substituted
Silica, colloidal anhydrous
Magnesium stearate

Film-coating:

Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

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.

Marketing authorization holder

MYLAN S.A.S, 117 Allée des Parcs, 69800 Saint-Priest, France

Marketing authorization dates and numbers

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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