Prodotti GS / Area HIV
Newsletter Luglio 2021_ Variazioni RCP Prodotti HIV
|
Product |
Submission description |
RCP availability |
|
Atripla |
Type IB variation to update SmPC section 4.5 and Package leaflet section 2 to include information relating to co-administration of metamizole with efavirenz. |
Fine Agosto 2021 |
|
Emtriva |
|
|
|
Viread |
HBV-GS-US-0174-0144-(wk 192)-Article-46 |
Fine Ottobre 2021 |
|
Stribild |
Type II variation to submit DDI with cutaneous corticosteroids
|
Fine Ottobre 2021 |
|
Truvada |
|
|
|
Eviplera |
|
|
|
Genvoya |
Type II Variation to add long-term safety and efficacy data (Week 48) from GS-US-292-0106 for existing Cohort 2 for patients weighing ≥ 25 kg to < 35 kg and aged 6 to < 12 years of age. |
Fine Agosto 2021 |
|
Type II variation to submit DDI with cutaneous corticosteroids
|
Fine Ottobre 2021 |
|
|
Descovy |
|
|
|
Odefsey |
|
|
|
Biktarvy |
|
|
|
Newsletter Luglio 2021 |
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