PIFELTRO Film-coated tablet Ref.[7599] Active ingredients: Doravirine

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Pifeltro 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 700 on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of doravirine.

Excipient with known effect: Each film-coated tablet contains 222 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Doravirine

Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Doravirine does not inhibit the human cellular DNA polymerases α, β, and mitochondrial DNA polymerase γ.

List of Excipients

Tablet core:

Croscarmellose sodium (E468)
Hypromellose acetate succinate
Lactose monohydrate
Magnesium stearate (E470b)
Microcrystalline cellulose (E460)
Silica, colloidal anhydrous (E551)

Film-coating:

Carnauba wax (E903)
Hypromellose (E464)
Lactose monohydrate
Titanium dioxide (E171)
Triacetin (E1518)

Pack sizes and marketing

Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant.

The following pack sizes are available:

  • 1 bottle with 30 film-coated tablets.
  • 90 film-coated tablets (3 bottles of 30 film-coated tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/18/1332/001
EU/1/18/1332/002

Date of first authorisation: 22 November 2018

Drugs

Drug Countries
PIFELTRO Austria, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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