Infectious diseases

Bacterial infections

• Amikacine ^IND

• Bedaquiline

  • Extension of indication to include treatment of paediatric patients (2 years to less than 5 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
• Ceftobiprole medocaril
• Contezolid

• Dalbavancine

  • Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth.

• Eravacycline

  • Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI)
• Faecal microbiota transplant
• Funobactam
• Gepotidacin

• Imipenem / Cilastatin / Relebactam

  • Imipenem/cilastatin/relebactam monotherapy for treatment of gram-negative Bacterial infection in newborns, infants, toddlers, children and adolescents with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infection, or complicated urinary tract infection.

• Minocycline

  • Minocycline in combination with standard antibiotics for adjunctive treatment of catheter-related infections and central line sepsis in adolescents, adults and the elderly.
• Nacubactam

• Pretomanid

  • Extension of indication to include in combination with bedaquiline, linezolid and moxifloxacin the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid

• Tedizolid

  • Extension of the indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) for adults, adolescents and children weighing at least 35 kg.
• Zoliflodacin

COVID-19

• Bio101

• Casirivimab / imdevimab

  • Extension of the indication to include the treatment of pediatric patients from 2 to less than 12 years of age, weighing at least 10 kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve.

• Ensitrelvir

  • Treatment of coronavirus disease 2019 (COVID-19).
• Nirmatrelvir / ritonavir ^IND
• Pemivibart

• Remdesivir

  • Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg).
• Sabizabulin
• Sipavibart
• Vilobelimab

Fungal infections

• Isavuconazole

  • Cresemba hard capsules are indicated in adults and paediatric patients aged 6 years and older for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is not suitable.
• Miconazole
• Olorofim

• Posaconazol

  • Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104.

HIV

• Darunavir / cobicistat

  • Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25kg).
  • Darunavir/cobicistat monotherapy for add-on treatment of HIV-1 infection in children over 3 years of age weighing at least 15kg.

• Darunavir / cobicistat / emtricitabine / tenofovir alafenamide

  • Darunavir/cobicistat/emtricitabine/tenofovir alafenamide monotherapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25kg.
• Doravirine / islatravir
• Emtricitabine/tenofovir alafenamide ^G

• Lenacapavir

  • The full indication for Yeytuo solution for injection is:  Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). The full indication for Yeytuo film-coated tablets is: Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg for: oral loading, oral bridging.
• Pitavastatine

• Rilpivirine

  • Rekambys in combination with cabotegravir injection is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen with no current or previous evidence of viral resistance to, and no previous virologic failure with, non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase inhibitors (INIs) classes.

Viral infections other

• Baloxavir marboxil

  • Extension of the indication to include the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 3 weeks and older.

• Bulevirtide

  • Extension of the indication for the treatment of chronic hepatitis delta virus (HDV) infection in pediatric patients aged 3 years and older weighing at least 10 kg with compensated liver disease for Hepcludex.
• Clesrovimab

• Letermovir

  • Letermovir monotherapy for the prophylactic treatment of reactivation of cytomegalovirus infection in neonates, infants, toddlers, children and adolescents at risk of developing CMV infection following allogeneic hematopoietic stem cell transplantation.

• Nirsevimab

  • Extension of the indication for the prevention of respiratory syncytial virus (RSV) in the lower respiratory tract for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• Pritelivir