EMEA-001825-PIP01-15-M05 - paediatric investigation plan
darunavir
cobicistat
emtricitabine
tenofovir alafenamide
PIPHuman
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Key facts
- Invented name
- Symtuza
- Active substance
- darunavir
- cobicistat
- emtricitabine
- tenofovir alafenamide
- Therapeutic area
- Infections and infestations
- Decision number
- P/0284/2024
- PIP number
- EMEA-001825-PIP01-15-M05
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of human immunodeficiency virus type-1 (HIV-1) infection
- Route(s) of administration
- Oral use
- Contact for public enquiries
Janssen-Cilag International NV
Tel. + 32 1460 2111
E-mail: contact@janssen-emea.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Non