Infectious diseases

Bacterial infections

• Amikacine ^IND
• Amoxicilline / omeprazol / rifabutin
• Aztreonam / avibactam

• Bedaquiline

  • Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
  • Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
  • 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.
• Bezlotoxumab ^IND
• Cadazolid
• Cefiderocol

• Ceftaroline fosamil

  • Extension of indication for the treatment of community acquired pneumonia (CAP) to include concurrent bacteraemia due to Streptococcus pneumoniae (SP) for all age groups.
  • Indicatie uitbreiding voor de behandeling van kinderen jonger dan twee maanden voor gecompliceerde infecties van de huid en van de weke delen (Complicated Skin and Soft Tissue Infection, cSSTI) en buiten het ziekenhuis opgelopen pneumonie (Community-acquired pneumonia, CAP).

• Ceftazidime / avibactam

  • Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, the currently approved indications for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia, including ventilator-associated pneumonia.
  • Zavicefta is indicated in adults and children aged 3 months and older and adolescents for the treatment of the following infections in adults with Complicated intra-abdominal infection (cIAI), Complicated urinary tract infection (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
  • Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) and in the treatment of infections due to aerobic Gram-negative organisms in patients with limited treatment options.
• Ceftobiprole
• Ceftobiprole medocaril
• Ceftolozaan / tazobactam ^IND
• Ceftolozane / tazobactam ^IND
• Citric acid / lactic acid / potassium bitartrate ^IND
• Clindamycin
• Contezolid

• Dalbavancine

  • Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
  • Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth.

• Delafloxacin

  • Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450mg tablets and 300mg powder for concentrate for solution for infusion.
  • Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

• Delamanid

  • Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents and children with a body weight of at least 30kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
  • Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, and children and infants with a body weight of at least 10kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
• Durlobactam / sulbactam

• 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)
  • Xerava is geïndiceerd voor de behandeling van gecompliceerde intra-abdominale infecties (cIAI’s) bij volwassenen.
• Faecal microbiota transplant
• Funobactam
• Gepotidacin
• Iclaprim

• 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.

• Imipenem / cilastatin / relebactam

  • Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
  • Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
• Lefamulin
• Liposomaal amikacine
• Meropenem / vaborbactam

• 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
• Nemonoxacin
• Obiltoxaximab
• Omadacycline
• Oritavancin diphosphate ^IND
• Ozenoxacine
• Plazomicin

• 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
  • Pretomanid FGK is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
• Recombinant vaccin voor meningokokken groep B
• Ridinilazole
• SER 109
• Sulopenem
• Tebipenem

• Tedizolid

  • Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.
  • 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.
  • Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens
• Tigecycline ^G

• Vonoprazan

  • Patients with Helicobacter pylori infection.
• Zoliflodacin

COVID-19

• APN01

• Anakinra

  • COVID-19 in adults with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.
• Bamlanivimab/ etesevimab

• Baricitinib

  • Extension of indication to include treatment of coronavirus disease 2019 (Covid 19) in hospitalised adult and paediatric patients aged 10 years and older who require low-flow oxygen or non invasive ventilation/high flow oxygen for Olumiant.
• 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.
  • Extension of indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
  • Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg .

• Dapagliflozine

  • Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival.

• Ensitrelvir

  • Ensitrelvir monotherapy for the treatment of mild and moderate COVID-19 in non-hospitalised adults and the elderly.
  • Treatment of coronavirus disease 2019 (COVID-19).
• Molnupiravir
• Nirmatrelvir / ritonavir ^IND
• PF-07321332 / ritonavir
• Pemivibart
• Regdanvimab ^IND

• Remdesivir

  • Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
  • 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).
  • Treatment of paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) or other non-invasive ventilation at start of treatment
  • Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).
• Sabizabulin
• Sipavibart
• Sotrovimab

• Tixagevimab / cilgavimab

  • Evusheld is indicated for the treatment of adults and adolescents (aged 12 years and older weighing at least 40kg) with COVID‑19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
  • Pre-expositie profylaxe van COVID-19 bij volwassenen en adolescenten van 12 jaar en ouder met een lichaamsgewicht van tenminste 40 kilo

• Tocilizumab

  • Extension of indication to include the treatment of coronavirus disease 2019 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation for RoActemra.
• Vilobelimab

Fungal infections

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis

• 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
• Oteseconazole

• Posaconazol

  • Extension of indication to include primary treatment of invasive aspergillosis in paediatric patients from 2 years of age weighing more than 40kg and adults for Noxafil gastroresistant tablet and concentrate for solution for infusion. Noxafil gastro-resistant tablets and solution are indicated for use in the treatment of the following fungal infections: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products.
  • Extension of indication to include primary treatment of invasive aspergillosis in adults and adolescents from 13 years of age for Noxafil gastroresistant tablet and concentrate for solution for infusion.
  • 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.
• Rezafungin

HIV

• Atazanavir / cobicistat
• Cabotegravir

• 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.
• Dolutegravir/ abacavir /lamivudine ^IND
• Doravirine / islatravir
• Doravirine / ​lamivudine / ​tenofovirdisoproxil ^IND
• Emtricitabine/tenofovir alafenamide ^G
• Etravirine ^IND
• Fostemsavir

• Lenacapavir

  • In Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance Adult aged ≥18 years or adolescent aged ≥12 and weighing ≥35kg.
  • 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
• Raltegravir ^BS

• Rilpivirine

  • Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml
  • 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.
• Semzuvolimab

Infectious diseases other

• Anidulafungin ^IND

• Baloxavir marboxil

  • Extension of indication for the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 1 years and above.
• Benznidazole
• Cefepime / enmetazobactam
• Cefepime/taniborbactam
• Fluticasone propionate

• Human normal immunoglobulin

  • Replacement therapy in adults, children and adolescents (0‑18 years) in: Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/l.

• Ibrexafungerp

  • Invasive Candidiasis

• Isavuconazole

  • Geïndiceerd voor gebruik bij volwassenen voor de behandeling van invasieve aspergillose en mucormycose bij patiënten voor wie amfotericine B niet geschikt is.

• Posaconazol

  • Posaconazole AHCL is indicated for treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
  • Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Parasitic infections

• Lotilaner

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.
  • Treatment of influenza: Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years and above. Post‑exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Xofluza should be used in accordance with official recommendations.
• Bictegravir / emtricitabine / tenofovir alafenamide fumaraat
• Bizalimogene ralaplasmid

• Bulevirtide

  • Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.
  • 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.
• CMV DNA vaccin (ASP0113)
• Clesrovimab

• 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 adolescents (aged 12 years and older, weighing at least 40 kg).

• Darunavir / cobicistat / emtricitabine / tenofovir alafenamide

  • Symtuza is geïndiceerd voor de behandeling van een infectie met het humaan immunodeficiëntievirus-1 (hiv-1) bij volwassenen en bij adolescenten (12 jaar en ouder met een lichaamsgewicht van minstens 40 kg).
• Dexamethasone ^IND
• Dolutegravir / lamivudine
• Dolutegravir / rilpivirine
• Doravirine
• Doravirine / lamivudine / tenofovir disoproxil (fumarate)
• Elbasvir / grazoprevir ^IND
• Emtricitabine / tenofovir disproxil fumarate

• Glecaprevir / pibrentasvir

  • Behandeling van chronishe hepatitis C virusinfectie (genotype 1-6) bij volwassenen.
  • Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents children aged 3 years and older.
  • Extension of indication to extend the Maviret indication to adolescents (from 12 to 18 years of age) with chronic hepatitis C infection.
• Ibalizumab

• Letermovir

  • Extension of indication to include treatment of prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
  • Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant.
  • Geïndiceerd voor de profylaxe van cytomegalovirus (CMV)-reactivatie en -ziekte bij volwassen CMV-seropositieve [R+] ontvangers van een allogene hematopoëtische stamceltransplantatie (HSCT).
  • 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.

• Lonafarnib

  • Hepatitis D infection with ritonavir
• Maribavir

• Nirsevimab

  • Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
  • 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.
• Peramivir
• Posoleucel
• Pritelivir
• Recombinant zoster vaccin

• Remdesivir

  • Veklury is geïndiceerd voor de behandeling van coronavirus disease 2019 (COVID-19) bij volwassenen en jongeren (vanaf 12 jaar die minstens 40kg wegen) met pneumonie die aanvullende zuurstof nodig hebben.
• Sofosbuvir / velpatasvir ^IND
• Sofosbuvir / velpatasvir / voxilaprevi ^IND
• Sofosbuvir / velpatasvir / voxilaprevir
• Tecovirimat
• Tenofovir alafenamide ^IND
• Tenofovir disoproxil ^IND
• Zanamivir