Newsletter Luglio 2021_ Variazioni RCP Prodotti HIV

Immagine News

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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