Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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. |
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) Film-coating: Carnauba wax (E903) |
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:
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/18/1332/001
EU/1/18/1332/002
Date of first authorisation: 22 November 2018
| Drug | Countries | |
|---|---|---|
| PIFELTRO | Austria, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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