Infectious diseases

Bacterial infections

• Amikacine ^IND
• Cefepime / zidebactam

• Cefiderocol

  • Extension of indication to include treatment of infections due to aerobic Gram-negative organisms in paediatric (birth to less than 18 years old) patients with limited treatment options.
• Ceftozolaan / tazobactam ^IND
• Contezolid

• Dalbavancine

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

• 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).
• Imipenem / cilastatin / funobactam

• Imipenem / cilastatin / relebactam

  • Recarbrio is indicated in adult and paediatric patients from birth for: - Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) (see sections 4.4 and 5.1). - Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP. - Treatment of infections due to aerobic Gram-negative organisms with limited treatment options (see sections 4.2, 4.4, and 5.1).

• 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

  • Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid. Dovprela is indicated in combination with bedaquiline and linezolid for the treatment of adults with pulmonary TB due to M. tuberculosis resistant to rifampicin and a fluoroquinolone, with or without resistance to isoniazid (see sections 4.2, 4.4 and 5.1).
• Zoliflodacin ^BS

COVID-19

• Ensitrelvir

  • Treatment of coronavirus disease 2019 (COVID-19).
• Ibramvibart
• Ibuzatrelvir
• 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).
• Sipavibart
• Vilobelimab

Fungal infections

• 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

  • Darunavir/cobicistat 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 combination therapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25kg.

• Dolutegravir / Lamivudine

  • Extension application to include treatment of children weighing at least 20 kg for Dovato.
• 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.

Parasitic infections

• Ganaplacide / lumefantrine

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.
• Bepirovirsen
• Cantharidin
• Clesrovimab

• Glecaprevir / pibrentasvir

  • Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older
• Pritelivir

Unknown

• Human normal immunoglobulin

  • Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or not advised. Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.