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Published on 4 December 2025

Oncology

• 177Lu-PNT2002

• Acalabrutinib

  • diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL.
• Afamitresgene autoleucel

• Alectinib

  • Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence.
• Amisulpride

• Amivantamab

  • Amivantamab in combination with lazertinib is indicated for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor.
  • Amivantamab monotherapy for treatment of locally advanced or metastatic EGFR-mutated Non-small cell lung cancer in adults and elderly who are not amenable to curative therapy including surgical resection or chemoradiation.

• Apalutamide

  • Als neo-adjuvante en adjuvante behandeling in combinatie met ADT bij mannen met hoog-risico lokaal/lokaalgevorderde prostaatkanker die een radicale prostatectomie ondergaan.

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
  • Atezolizumab in combination with lenvatinib for second line treatment of locally advanced or metastatic and/or unresectable hepatocellular carcinoma in adults and elderly who have progressed on prior systemic treatment with atezolizumab plus bevacizumab.
  • Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
  • Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy.
• Aumolertinib (mesilate)
• Azenosertib

• Belzutifan

  • WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
  • WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
  • Belzutifan in combination with lenvatinib for advanced renal cell carcinoma.
  • Belzutifan in combination with pembrolizumab as adjuvant treatment of clear cell renal cell carcinoma
• Berubicin
• Bezuclastinib
• Buparlisib

• Cabozantinib

  • Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

• Camizestrant

  • Camizestrant in combination with CDK4/6 inhibitors for add-on treatment of locoregionally recurrent or metastatic ER-positive, HER2-negative, ESR1-positive Breast cancer in adults and elderly.
  • Camizestrant in combination with palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.
• Camrelizumab

• Capivasertib

  • Extension of indication to include include Truqap in combination with abiraterone for the treatment of metastatic castration-sensitive prostate cancer characterized by PTEN deficient tumours.
  • Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

• Catequentinib

  • Treatment of synovial sarcoma or leiomyosarcoma.
  • Catequentinib in combination with background chemotherapy for third line or later treatment of recurrent or metastatic cervical cancer, endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinosarcoma in adults and elderly.
• Catumaxomab

• Cemiplimab

  • Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
• Ceralasertib
• Cetuximab sarotalocan
• Cobolimab
• Cosibelimab
• Cretostimogene grenadenorepvec

• Dabrafenib / trametinib

  • Extension of indication to include treatment of unresectable or metastatic melanoma with a BRAF V600 mutation and adjuvant treatment of Stage III melanoma with a BRAF V600 mutation for adolescents aged 12 years and older.
  • Treatment of differentiated thyroid cancer (DTC)

• Daratumumab

  • Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant.

• Darolutamide

  • Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).
• Daromun
• Darovasertib

• Datopotamab deruxtecan

  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with locally recurrent inoperable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
  • Datopotamab deruxtecan with or without osimertinib is indicated for patients with advanced or metastatic EGFRm NSCLC whose disease has progressed on prior Osimertinib.
  • Datopotamab deruxtecan in combination with durvalumab is indicated for the treatment of stage I-III triple-negative breast cancer in patients who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
• Db-1303/bnt323

• Denosumab

  • Preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen van solide tumoren. Behandeling van volwassenen en adolescenten met een volgroeid skelet met reusceltumor van het bot (‘giant cell tumour of bone’) die niet-reseceerbaar is of waarbij chirurgische resectie waarschijnlijk leidt tot ernstige morbiditeit.
• Detalimogene voraplasmid

• Domvanalimab

  • first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
• Dordaviprone

• Dostarlimab

  • Extension of indication for JEMPERLI to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
  • Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer").

• Durvalumab

  • Extension of indication for IMFINZI to include in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.
  • Extension of indication for IMFINZI in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).
  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • Durvalumab in combination with enfortumab vedotin for neoadjuvant and durvalumab monotherapy for adjuvant treatment of muscle-invasive urothelial carcinoma bladder in adults and elderly who are cisplatin-ineligible or refused cisplatin and are undergoing radical cystectomy (VOLGA).
  • Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).
  • IMFINZI in combinatie met tremelimumab is geïndiceerd voor de eerstelijnsbehandeling van volwassenen met gevorderd of irresectabel hepatocellulair carcinoom (HCC).
  • Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma  (KUNLUN).
  • Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.
  • Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
  • A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. PACIFIC-9.
  • Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/​ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4).
• Eflornithine ^IND
• Emactuzumab

• Encorafenib

  • Encorafenib in combination with cetuximab and chemotherapy for first line treatment of stage IV metastatic BRAF V600E-mutant Colorectal cancer in adolescents over 16 years of age, adults and elderly.
  • Encorafenib in combination with binimetinib and pembrolizumab for first line treatment of metastatic or unresectable locally advanced BRAF V600E/K mutation-positive cutaneous melanoma in adults and elderly.

• Enfortumab vedotin

  • Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.
• Ensartinib

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult and pediatric patients older than 1 month with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment option.
• Fianlimab
• Furmonertinib

• Gedatolisib

  • Gedatolisib in combination with palbociclib and fulvestrant for second line or later treatment of advanced or metastatic PIK3CA mutated Hormone receptor positive HER2 negative breast cancer in adults and elderly previously treated with CDK4/6 and aromatase inhibitor therapy.
• Gemcitabine ^IND
• Giredestrant
• Glufosfamide
• Hexaminolevulinate hydrochloride
• Imlunestrant
• Imsamotide
• Inavolisib

• Ipilimumab

  • Neo-adjuvant (off-label) treatment with ipilimumab plus nivolumab followed by adjuvant treatment in high-risk patients only.

• Ivonescimab

  • First line treatment of stage IIIB / C or IV locally advanced or metastatic PD-L1-positive nonsmall cell lung cancer in adults and elderly with no EGFR-sensitive mutations or ALK gene translocations.
  • Ivonescimab in combination with pemetrexed and carboplatin for second line treatment of locally advanced or metastatic EGFR-mutant Non-squamous non-small cell lung cancer in adults and elderly who have progressed on or following EGFR-TKI treatment.
• Ivospemin
• Lazertinib

• Lifileucel

  • Lifileucel in combination with pembrolizumab and follow-on IL-2 for first line or later treatment of metastatic stage IIIc, IIId, or IV unresectable melanoma in adults and elderly following lymphodepletion regimen.
  • Lifileucel in combination with follow-on IL-2 for second line treatment of stage IIIc/IV unresectable or metastatic Melanoma in adults and elderly.

• Lurbinectedin

  • Small cell lung cancer (SCLC).
  • Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
  • Lurbinectedin monotherapy for second line treatment of relapsed Small cell lung cancer in adults and elderly who failed one prior platinum-containing chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.
• Lutetium (177Lu) edotreotide

• Lutetium (177Lu) oxodotreotide

  • Extension of indication to include the treatment of unresectable or metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adolescents aged 12 years and older.

• Lutetium (177lu) vipivotide tetraxetan

  • Extension of indication to include treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after having progressed on androgen receptor pathway inhibitor (ARPI) and for whom chemotherapy is not yet clinically indicated.
• MDM2-p53 antagonist
• Mevrometostat
• Mirdametinib
• Mirvetuximab soravtansine
• Mitomycine extended release
• Nadofaragene firadenovec
• Namodenoson
• Naxitamab
• Neladalkib
• Nemvaleukin alfa
• Nibrozeton

• Niraparib / abirateron

  • In combinatie met predniso(lo)n en ADT voor de behandeling van mannen met mHSPC en afwijkingen in genen betrokken bij het herstel van DNA via homologe recombinatie (HRR+ mHSPC).
• Nirogacestat

• Nivolumab

  • Extension of indication to include in combination with cisplatin-based chemotherapy the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
  • Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).
  • Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW.
  • Extension of indication to include OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or metastatic mismatch repair deficient or microsatellite instability-high colorectal cancer.
• Nivolumab/hyaluronidase Ph20 ^IND
• Nivolumab/relatlimab/hyaluronidase Ph20
• Nofazinlimab

• Nogapendekin Alfa Inbakicept

  • Nogapendekin alfa inbakicept in combination with pembrolizumab, carboplatin and nab-paclitaxel for first line treatment of advanced or metastatic, stage 3 or 4 Non-small cell lung cancer in adults and elderly.

• Nogapendekin alfa inbakicept

  • Nogapendekin alfa in combination with bacillus calmette-guerin for third line treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer in adults and elderly with carcinoma in situ with or without papillary tumors.
• OST31-164

• Olaparib

  • Extension of indication for Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
  • In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
  • Monotherapie of in combinatie met endocriene therapie voor de adjuvante behandeling van volwassen patiënten met kiembaan-BRCA1/2-mutaties die HER2-negatieve, hoog-risico borstkanker in een vroeg stadium hebben en eerder behandeld zijn met neoadjuvante of adjuvante chemotherapie.
• Olvimulogene nanivacirepvec
• Onfekafusp Alfa

• Osimertinib

  • Extension of indication to include TAGRISSO in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations
  • Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA).
• Ozekibart

• Paclitaxel

  • Paclitaxel monotherapy for first line treatment of recurrent or metastatic HER2 negative breast cancer in adults over 19 years of age and elderly.
• Paclitaxel/hyaluronic acid

• Padeliporfin

  • Padeliporfin monotherapy for first line treatment of low grade non-invasive Renal pelvis and ureter transitional cell cancer localized in adults and elderly.
• Palazestrant

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.
• Patritumab deruxtecan
• Pegargiminase

• Pembrolizumab

  • Pembrolizumab in combination with gemcitabine and cisplatin followed by surgery and postoperative pembrolizumab for neoadjuvant treatment of non-metastatic muscle invasive Bladder cancer in adults and elderly who are eligible for radical cystectomy and pelvic lymph node dissection.
  • Pembrolizumab in combination with Bacillus Calmette-Guerin for adjuvant treatment of high risk non-muscle invasive bladder cancer in adults and elderly who have undergone cystoscopy/TURBT and are BCG-naive.
  • Extension of indication to include in combination with paclitaxel, with or without bevacizumab, the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.
  • Pembrolizumab in combination with carboplatin/paclitaxel chemotherapy with or without bevacizumab followed by pembrolizumab+olaparib maintenance for first line treatment of stage III or IV BRCA non-mutated Fallopian tube cancer, Ovarian epithelial cancer, Primary peritoneal carcinosarcoma in adults and elderly.
  • Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
  • Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
  • Pembrolizumab (MK-3475) Subcutaneous (SC) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
  • Pembrolizumab in combination with sacituzumab govitecan for first line treatment of metastatic Non-small cell lung cancer in adults and elderly with PD-L1 proportion score greater than or equal to 50%.
  • Adjuvant pembrolizumab in patients with hepatocellular carcinoma (HCC) and complete radiologic response after surgical resection or local ablation.
  • Keytruda, in combination with chemoradiotherapy, is indicated for the treatment of adults with muscle-invasive bladder cancer (MIBC) who choose bladder preservation.
  • Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC).
  • Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma.
  • Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery.
  • Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma
• Pembrolizumab / berahyaluronidase alfa ^IND
• Pimicotinib
• Radium-223 ^IND

• Relacorilant

  • Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Relatlimab / nivolumab
• Repotrectinib

• Retifanlimab

  • Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal (squamous cell anal cancer (SCAC)), 1L (ODD) (+CT).
  • Lokaal gevorderd of gemetastaseerd stage IV niet-kleincellige longkanker eerste lijn.

• Ribociclib

  • Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali.
• Ripretinib
• Rosopatamab tetraxetan lutetium (177Lu)

• Rucaparib

  • Treatment of metastatic castration resistant prostate cancer (CRPC) associated with a deleterious alteration in either the BRCA1, BRCA2 or ATM genes.

• Sacituzumab govitecan

  • Trodelvy is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
  • For adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease
• Sasanlimab
• Savolitinib

• Selinexor

  • Maintenance with selinexor after combination chemotherapy for patients with advanced or recurrent endometrial cancer.

• Selpercatinib

  • Extension of indication to include to include paediatric patients 2 years and older with: (1) Advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory, (2) Advanced RET-mutant medullary thyroid cancer, (3) Advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.

• Selumetinib

  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).
  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.
• Senaparib

• Serplulimab

  • Extension of indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.
  • Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.
  • Extension of indication to include HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma who do not have EGFR or ALK positive mutations.
  • Extension of indication to include, in combination with fluoropyrimidine- and platinum-based chemotherapy, the first-line treatment of adult patients with unresectable, locally advanced/recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 1
• Sigovatug vedotin

• Sugemalimab

  • Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of adults with metastatic non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
  • Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.
  • Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
• Sunvozertinib
• Sv-br-1-gm

• Talazoparib

  • Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • Talzenna in combinatie met enzalutamide is geïndiceerd voor de eerstelijnsbehandeling van patiënten met een gemetastaseerd, hormoonsensitief HRR+ prostaatcarcinoom
• Taletrectinib
• Tarlatamab

• Tebentafusp

  • Tebentafusp in combination with pembrolizumab for second line or later treatment of stage III or IV unresectable HLA-A*02:01 positive non-ocular Melanoma in adults and elderly who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor.
• Temozolomide ^IND
• Tinengotinib

• Tiragolumab

  • In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy.

• Tislelizumab

  • Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
  • Extension of indication to include in combination with platinum-based chemotherapy the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC).
  • Extension of indication to include in combination with platinum and fluoropyrimidine-based chemotherapy the first-line treatment of adult patients with human epidermal growth factor receptor-2 (HER-2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
  • Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1)
  • Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.
  • Extension of indication to include, Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC).
• Tisotumab vedotin

• Toripalimab

  • Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
  • Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.
• Tovorafenib

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
  • Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DG04).
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
  • Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DB05).
  • Extension of indication to include treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory alternative treatment options.
  • Trastuzumab deruxtecan (Enhertu) with or without pertuzumab compared to standard of care in patients with HER2-positive metastatic breast cancer (DB09).
  • first-line treatment in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DL04).
• Trastuzumab pamirtecan

• Tremelimumab

  • Tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC) (EMERALD-3).
  • Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
• Trilaciclib

• Tucatinib

  • Maintenance treatment of unresectable locally advanced or metastatic HER2 positive breast cancer.
  • Treatment of patients with unresectable locally advanced or metastatic HER2 positive colorectal cancer.
• Tucidinostat
• Vimseltinib
• Vorasidenib

• Zanidatamab

  • Zanidatamab in combination with chemotherapy for first line treatment of unresectable locally advanced, recurrent or metastatic HER2-positive gastric, gastro-oesophageal junction and oesophageal adenocarcinoma in adults and elderly.
  • Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).

• Zanzalintinib

  • Zanzalintinib in combination with nivolumab for first line treatment of unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma in adults and elderly.
  • Zanzalintinib in combination with atezolizumab for third line treatment of microsatellite stable or microsatellite instability low metastatic colorectal cancer in adults and elderly who have progressed after or are intolerant to standard-of-care therapy.
• Zenocutuzumab
• Zidesamtinib
• Zopapogene imadenovec

Hematology

• ARI-0001

• Acalabrutinib

  • Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
  • Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).

• Asciminib

  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)
  • Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) harbouring the T315I mutation.

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

• Belantamab mafodotin

  • Second line treatment of r/r multiple myeloma in adults and elderly, in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone.
• Belumosudil

• Blinatumomab

  • Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.

• Bosutinib

  • Paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). Paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

• Brentuximab vedotin

  • Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage 3 or Stage 4 HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1)

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

• Ciltacabtagene autoleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 1 prior therapy, including an IMiD and a PI, have demonstrated disease progression on or after the last therapy and are refractory to lenalidomide.

• Daratumumab

  • Extension of indication for Darzalex in combination with bortezomib, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma, to include also adult patients who are not eligible for stem cell transplant (SCT).
  • Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1).

• Decitabine / cedazuridine

  • Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
  • Extension of indication to include treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
• Dorocubicel

• Elranatamab

  • Elrexfio is geïndiceerd voor volwassen patiënten met gerecidiveerd en refractair multipel myeloom, die ten minste drie eerdere behandelingen hebben gekregen, waaronder een immuno modulator, een proteasoom remmer en een anti CD38 antilichaam en die tijdens de laatste behandeling ziekteprogressie hebben vertoond.
  • Elranatamab monotherapy for relapsed/refractory multiple myeloma patients who have received anti CD38 directed therapy and lenalidomide.
  • Monotherapy for the treatment of patients with relapsed and refractory multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor, and an immunomodulatory agent.

• Epcoritamab

  • Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • 2L Follicular Lymphoma
• Etuvetidigene autotemcel
• Galinpepimut-S

• Gemtuzumab ozogamicin

  • Extension of indication to include, in combination with mitoxantrone and cytarabine (AraC), the treatment of paediatric patients aged 1 year to less than 18 years with newly diagnosed CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL)

• Givinostat

  • Givinostat monotherapy for treatment of high-risk JAK2V617F-positive polycythaemia vera in adults and elderly.

• Glofitamab

  • Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
• Iberdomide

• Ibrutinib

  • Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT)

• Idecabtagene vicleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.
• Imetelstat
• Inotuzumab ozogamicine ^IND

• Isatuximab

  • Extension of indication to include in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
  • Isatuximab subcutaan in combinatie met pomalidomide en dexamethason voor de behandeling van volwassen patiënten met gerecidiveerd en refractair multipel myeloom (MM) die minstens twee eerdere therapieën hebben gekregen, waaronder lenalidomide en een proteasoomremmer (maar niet refractair zijn op daratumumab) en bij wie ziekteprogressie is aangetoond tijdens de laatste behandeling.
  • In combination with bortezomib, lenalidomide and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• Linvoseltamab

• Lisocabtagene maraleucel

  • Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant.
  • Lisocabtagene maraleucel is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

• Loncastuximab tesirine

  • Loncastuximab tesirine in combination with rituximab for second line or later treatment of relapsed or refractory Diffuse large B-cell lymphoma in adults and elderly who are ineligible for stem cell transplantation.

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia Extension of indication in β-thalassaemia to include adult patients with non-transfusion dependent β-thalassaemia (NTDT).
• MaaT013

• Mezigdomide

  • Mezigdomide in combination with carfilzomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have received prior treatments with lenalidomide and an anti-CD38 monoclonal antibody.
  • Mezigdomide in combination with bortezomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have had prior lenalidomide exposure.

• Mosunetuzumab

  • Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy.
• Narsoplimab
• Navitoclax
• Nemtabrutinib

• Nivolumab

  • Extension of indication for OPDIVO to include treatment of patients paediatric and adults, with relapsed/refractory classical Hodgkin Lymphoma in combination with brentuximab vedotin.
  • Extension of indication to include OPDIVO for the treatment of adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL)
• Nomacopan
• Obecabtagene autoleucel
• Olutasidenib

• Pirtobrutinib

  • Pirtobrutinib monotherapie voor de tweedelijns of latere behandeling van mantelcellymfoom bij volwassenen en ouderen die nog geen BTK-remmer hebben gebruikt.
  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor.

• Ponatinib

  • Extension of indication to include treatment of adult patients with newly-diagnosed Ph+ ALL.
  • Extension of Indication to include treatment of paediatric patients aged 6 years and older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant or intolerant to at least one tyrosine kinase inhibitor
• Revumenib
• Sargramostim

• Selinexor

  • In combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die tenminste één eerdere therapie hebben ondergaan.
• Sonrotoclax
• Soquelitinib

• Tafasitamab

  • Minjuvi is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
  • Tafasitamab in combinatie met lenalidomide is geïndiceerd in combinatie met rituximab, cyclofosfamide, doxorubicine, vincristine en prednison (R-CHOP) voor de behandeling van volwassen patiënten met onbehandeld diffuus grootcellig B-cellymfoom (DLBCL).

• Talquetamab

  • Talquetamab is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom die minimaal drie eerdere behandelingen hebben gekregen, waaronder een immuno-modulerend middel een proteasoom-remmer en een antiCD38antilichaam. En die tijdens de laatste therapie ziekteprogressie hebben vertoond.
  • Talquetamab in combination with pomalidomide and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.
  • Talquetamab in combination with teclistamab and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.
  • Talquetamab in combination with daratumumab, pomalidomide and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.
  • Talquetamab in combination with daratumumab and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.

• Teclistamab

  • Teclistamab monotherapy for second line or later treatment of progressive, relapsed or refractory Multiple myeloma in adults and elderly who have received an anti-CD38 monoclonal antibody and lenalidomide in any previous line.

• Tislelizumab

  • Tislelizumab monotherapy for third line, salvage treatment of relapsed or refractory classical Hodgkin lymphoma in adults and elderly.
• Ziftomenib

Metabolism and Endocrinology

• Alpelisib

  • PIK3CA-Related Overgrowth Spectrum (PROS). PROS omvat de onderstaande syndromen: - Goedaardige lichenoïde keratose (BLK) - Dysplastische megalencefalie (DMEG) - CLOVES (aangeboren lipomateuze overgroei, vasculaire malformatie, epidermal naevi-syndroom) - Epidermal naevi (EN) - Fibro-adipeuze overgroei (FAO) - Hemimegalencefalie (HMEG) - Hemihyperplasie - meervoudige lipomatose (HHML) geïsoleerde grote lymfatische malformatie (ILM) - Megaencefalie- capillaire malformatie (MCAP) - Muscular hemihyperplasia (mHH) - Seborrhoïsche keratose (SK)

• Arimoclomol

  • Treatment of Niemann-Pick disease type C (NPC) in patients aged 6 months and older in combination with miglustat.
• Atidarsagene autotemcel ^IND
• Autologous human chondrocytes in vitro expanded
• BCAA-vrije aminozuren

• Burosumab

  • Extension of indication to include treatment of X-linked hypophosphataemia (XLH) in paediatric patients from birth to less than 1 year of age.

• Canagliflozine

  • Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
• Carbetocine
• Clemidsogene lanparvovec
• Coördinatieverbinding van ijzercitraat
• Crinecerfont

• Dasiglucagon

  • Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
  • Infants and children aged 7 days to 12 years with congenital hyperinsulinism (CHI).
• Denatonium Acetate Monohydrate
• Dersimelagon
• Diazoxide choline (controlled-release tablet)
• Efzimfotase alfa

• Elamipretide

  • Elamipretide monotherapy for treatment of primary Mitochondrial myopathy in adults and elderly with pathogenic nuclear DNA mutations.
  • Elamipretide monotherapy for treatment of Barth syndrome in male adolescents, adults and elderly.
• Eliglustat ^IND
• Elinzanetant
• Empagliflozine / metformine ^IND
• Encaleret
• Eneboparatide
• Ersodetug ^IND
• Estetrol

• Etelcalcetide

  • Etelcalcetide in combination with standard of care for treatment of Hyperparathyroidism secondary in infants and toddlers, children and adolescents with chronic kidney disease receiving maintenance hemodialysis.
• Glibenclamide ^IND

• Glucagon

  • Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 1 year and over with diabetes mellitus.

• Govorestat

  • Sorbitol dehydrogenase deficiency

• Hydrocortison

  • Treatment of adrenal insufficiency (AI) in adolescents aged 12 years and over and adults

• Infigratinib

  • Infigratinib monotherapy for treatment of Achondroplasia in children over 3 years of age and adolescents.
• Insulin efsitora alfa
• Insulin icodec / semaglutide
• L-acetylleucine
• Leriglitazon
• Linerixibat

• Linzagolix

  • Extension of indication to include treatment of endometriosis-associated pain in adult women of reproductive age.

• Liraglutide

  • Children (6 to <12 years): Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with obesity (BMI ≥95th percentile)* and body weight ≥45 kg Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years (see table 2), in accordance with study design of the Trial 4392, see section 5.1.
• Lonapegsomatropine ^IND

• Maralixibat

  • Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older.

• Migalastat

  • Migalastat monotherapy for treatment of Fabryʼs disease in adolescents, adults and elderly with amenable GLA variants and severe renal impairment not receiving any type of dialysis treatment.
  • Migalastat monotherapy for treatment of Fabry’s disease in adults and elderly with amenable GLA variants and end-stage renal disease who are receiving either standard hemodialysis or hemodiafiltration.
• Mirabegron ^IND
• Navepegritide
• Nedosiran
• Norucholzuur

• Octreotide

  • Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
• Paltusotine
• Pegunigalsidase alfa

• Pegvaliase

  • Extension of indication to include treatment of adolescent patients aged 12 to <16 years with PKU

• Pegzilarginase

  • Pegzilarginase monotherapy for treatment of Arginase 1 deficiency in newborns, infants and toddlers.
• Rebisufligene etisparvovec

• Relacorilant

  • Cushingʼs Syndrome
• Resmetirom
• Seladelpar

• Semaglutide

  • Op dit moment heeft oraal semaglutide reeds een indicatie voor diabetes. De aan te vragen indicatieuitbreiding zal slaan op het behandelen van obesitas.
  • Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis.
• Sepiapterin

• Setmelanotide

  • Extension of indication to include the population of children aged 2 years and above for the treatment of pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin Type 1 (PCSK1) deficiency or biallelic leptin receptor (LEPR) deficiency and Bardet-Biedl Syndrome (BBS) for IMCIVREE.
  • Extension of indication to include reduction in hunger (or hyperphagia) and BMI/BMI z-score, improvement of metabolic parameters, and increase in energy expenditure in adults and children 4 years of age and above, following rapid and severe weight gain associated with hypothalamic injury and/or impairment.
• Setrusumab

• Somapacitan

  • Somapacitan monotherapy for treatment of Short stature in children and adolescents either born small for gestational age or with Turnerʼs syndrome, Noonan syndrome, or idiopathic short stature.

• Somatrogon

  • Somatrogon monotherapy for treatment of growth hormone deficiency in adults.

• Sparsentan

  • Sparsentan monotherapy for treatment of primary and genetic Focal segmental glomerulosclerosis in children over 8 years of age, adolescents, adults and elderly.
• Teplizumab
• Teprotumumab
• Tiomolibdate choline

• Tirzepatide

  • Extension of indication to include treatment of adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
• Venglustat
• Vibegron
• Xylitol/l-carnitine/glucose

Chronic immune diseases

• 13-grass pollen extract

• Afamelanotide

  • Afamelanotide in combination with Narrow-Band Ultraviolet B (NB-UVB) light for treatment of stable or active generalized Vitiligo in adolescents, adults and elderly.
• Allergeenextract huisstofmijt ^IND

• Anifrolumab

  • Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (SubQ Tulip).
• Apraglutide
• Arachis hypogaea (pinda) allergenen ^IND
• Atacicept
• Atrasentan

• Baricitinib

  • Extension of indication to include treatment of adolescent patients (12 to less than 18 years) with severe alopecia areata.

• Belimumab

  • Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
• Beremagene geperpavec

• Berotralstat

  • Berotralstat monotherapy for prophylactic treatment of hereditary angioedema in children aged 2 to 12.
• Briquilimab

• Budesonide

  • Kinpeygo is indicated for the treatment of adults with a urine protein excretion-to-creatinine ratio (UPCR) ≥1,0g/dayg (or urine protein-to-creatinine ratio ≥0,8g/g).
• Clascoterone
• Dapansutrile

• Deucravacitinib

  • Sotyktu, alone or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
• Deucrictibant
• Deuruxolitinib
• Dipalmitoyl Hydroxyproline
• Donidalorsen

• Dupilumab

  • Dupixent is geïndiceerd voor de behandeling van eosinofiele oesofagitis in volwassenen, adolescenten en kinderen van een jaar en ouder. Die ongecontroleerd zijn op, intolerant zijn voor, of die geen kandidaat zijn voor conventionele therapie.
  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.
  • Dupixent is geindiceerd voor de behandeling van volwassenen met matig-ernstig bulleus pemfigoid (BP).
  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.

• Emapalumab

  • Emapalumab monotherapy for treatment of glucocorticoid-refractory Macrophage activation syndrome in infants, toddlers over 6 months of age, children, adolescents, adults and elderly with Stillʼs Disease.

• Etrasimod

  • Velsipity is geïndiceerd voor de behandeling van patiënten van 16 jaar en ouder met matig tot ernstig actieve colitis ulcerosa (CU) die onvoldoende reageren of niet meer reageren op of intolerant zijn voor conventionele behandeling of een biologisch middel.

• Filgotinib

  • Axial spondyloarthritis
• Garadacimab
• Glepaglutide
• Golimumab ^BS

• Guselkumab

  • Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy
  • Tremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.
  • Tremfya is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
• Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen

• Hydrocortison

  • Hydrocortisone monotherapy for treatment of active rectum Ulcerative colitis in adults and elderly.
• Ianalumab
• Icotrokinra

• Imlifidase

  • Imlifidase in combination with standard of care for treatment of severe anti-glomerular basement membrane disease in adults and elderly.
• Imsidolimab

• Inebilizumab

  • Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).

• Iptacopan

  • Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated.
• Ivarmacitinib

• Ixekizumab

  • Juvenile idiopathic arthritis (JIA). Juvenile psoriatic arthritis (JPsA): Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy. Enthesitis-related arthritis (ERA): Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.

• Lebrikizumab

  • Lebrikizumab in combination with topical corticosteroid for treatment of moderate to severe atopic dermatitis in infants, toddlers over 6 months, children and adolescents.

• Leniolisib

  • Behandeling van Geactiveerd PI3 Kinase Delta-Syndroom (APDS) bij volwassenen en adolescenten van twaalf jaar en ouder.
  • Leniolisib monotherapy for treatment of Activated PI3 kinase delta syndrome in infants, toddlers and children between 1 to 12 years of age.
• Lingolinurad
• Litifilimab
• Lonvoguran ziclumeran

• Masitinib

  • Masitinib in combination with best supportive care for third line or later treatment of severe Indolent systemic mastocytosis and of for the treatment of severe smouldering Systemic mastocytosis i in adults and elderly who are unresponsive to optimal symptomatic treatment.
• Mavorixafor

• Minocycline

  • Minocycline monotherapy for treatment of moderate to severe inflammatory lesions of Papulopustular rosacea in adults and elderly.

• Mirikizumab

  • Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
• Mycofenolaatmofetil ^IND
• Nemolizumab
• Obefazimod

• Obinutuzumab

  • Gazyvaro in combination with mycophenolate mofetil (MMF), is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN)

• Pegcetacoplan

  • Extension of indication to include treatment of adults and adolescents aged 12 to 17 years with C3 glomerulopathy or primary immune complex membranoproliferative glomerulopathy.
• Povorcitinib ^IND
• Prademagene zamikeracel
• Remibrutinib

• Risankizumab

  • Extension application to include treatment of paediatric plaque psoriasis (6 to 18 years)
  • Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

• Ritlecitinib

  • Treatment of patients with non-segmental vitiligo

• Roflumilast topicaal

  • Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age.

• Ruxolitinib (als fosfaat)

  • Volwassenen met matige atopische dermatitis die eerder zijn behandeld met topische corticosteroïden of topische calcineurine remmers of waarbij deze middelen zijn gecontra-indiceerd.

• Sarilumab

  • Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.
• Sebetralstat

• Secukinumab

  • Extension of indication to include polymyalgia rheumatica in adults whose disease has responded inadequately to, or cannot tolerate conventional therapy.
  • Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly.
• Secukinumab-bthr ^BS
• Sibeprenlimab
• Tadekinig alfa

• Teduglutide

  • Treatment of Short Bowel Syndrome.

• Tezepelumab

  • Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care treatment.

• Tildrakizumab

  • Tildrakizumab monotherapy for treatment of active psoriatic arthritis in adults and elderly who have prior or no prior exposure to an anti-tumor necrosis factor agent.
• Tirbanibuline ^IND

• Upadacitinib

  • Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
  • Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.
  • Severe Alopecia areata in adolescents and adults.
  • Non-segmental Vitiligo in adolescents, adults and elderly who are eligible for systemic therapy.
  • Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older

• Ustekinumab

  • Extension of indication to include treatment of moderately to severely active Crohnʼs disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
• Veligrotug
• Zasocitinib

Infectious diseases

• Amikacine ^IND

• 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.

• 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.
• Bio101

• 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.

• 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.
• Ceftobiprole medocaril
• Clesrovimab
• Contezolid

• Dalbavancine

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

• 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

• Ensitrelvir

  • Treatment of coronavirus disease 2019 (COVID-19).

• 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.

• 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.

• 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.

• 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.
• Miconazole

• 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
• Nirmatrelvir / ritonavir ^IND

• 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.
• Olorofim
• Pemivibart
• Pitavastatine

• 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.

• 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
• Pritelivir

• 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).

• 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.
• Sabizabulin
• Sipavibart

• 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.
• Vilobelimab
• Zoliflodacin

Lung diseases

• ARINA-1
• Alpha-1 antitrypsin

• Benralizumab

  • Extension of indication to include treatment of eosinophilic granulomatosis.
  • Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history.
• Brensocatib

• Ciclosporine

  • Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndrome in adults and the elderly after lung transplantation.
• Colistimethaatnatrium ^IND
• Depemokimab

• Dupilumab

  • Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
• Efzofitimod ^G
• Ensifentrine
• Exoflo Extracellular Vesicles

• Formoterol / glycopyronium / budesonide

  • Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2-agonist.
• Itepekimab
• Ivacaftor / Tezacaftor / Elexacaftor ^IND

• Mepolizumab

  • Extension of indication to include treatment of Chronic Obstructive Pulmonary Disease (COPD).
• Nerandomilast

• Nintedanib

  • Ofev is indicated in children and adolescents aged 6 to 17 years for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs).

• Riociguat

  • Adempas is indicated for the treatment of PAH in paediatric patients aged 6 to less than 18 years with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists (see section 5.1).

• Sotatercept

  • Treatment of pulmonary arterial hypertension.
  • Extension of indication to include in combination with other pulmonary arterial hypertension (PAH) therapies treatment of adult patients with PAH World Health Organisation Functional Class IV.
• Tanimilast

• Tezepelumab

  • Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.
• Tozorakimab ^IND

• Treprostinil

  • Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly.
• Vanzacaftor / tezacaftor / deutivacaftor

Neurological disorders

• Acoltremon
• Adezunap
• Apitegromab

• Atogepant

  • Acute Migraine in adults
• Atropine sulfate ^IND
• Baclofen / naltrexone / sorbitol
• Basimglurant
• Bexicaserin
• Bidridistrogene xeboparvovec
• Bimatoprost
• Blarcamesine
• Botaretigene sparoparvovec
• Brexpiprazol ^IND
• Brimonidine tartrate/carbachol

• Cannabidiol

  • Children and Adolescents With Fragile X Syndrome aged 3 to < 18 years.
• Casimersen
• Chloroprocaine ^IND
• Citicoline
• Condoliase
• Delandistrogene moxeparvovec
• Delpacibart zotadirsen
• Deramiocel
• Deutetrabenazine (extended release)
• Diflunisal
• Donanemab
• Doxecitine / doxiribtimine
• Ecopipam
• Efgartigimod alfa ^IND
• Empasiprubart
• Eplontersen

• Eptinezumab

  • Eptinezumab monotherapy for preventive treatment of Chronic migraine in children over 6 years of age and adolescents with or without aura.

• Fremanezumab

  • Fremanezumab monotherapy for preventive treatment of Chronic migraine, Episodic migraine in children over 6 years of age and adolescents.
• Gefurulimab

• Givinostat

  • Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment
• Gold Nanocrystals
• Hydromethylthionine mesylaat
• IBI311
• Ibudilast
• Iloperidon
• Incobotulinumtoxina

• Inebilizumab

  • Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or anti-MuSK antibody.
• Kyv-101
• Lecanemab
• Lenzumestrocel

• Levodopa / carbidopa

  • Levodopa/carbidopa monotherapy for treatment of Parkinson's disease in adults over 30 years of age and elderly who are experiencing motor fluctuations.

• Melatonine

  • Extension of indication for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
• Meloxicam / rizatriptan

• Mercaptamine

  • Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.
• Mexiletine ^IND
• Midazolam/ketamine
• Nepla-tem-cel
• Nipocalimab

• Nusinersen

  • Nusinersen monotherapy for treatment of 5q Spinal muscular atrophy in newborns, infants, toddlers, children, adolescents and adults administered at a higher dose
• OCU400
• Olanzapine (long-acting injectable)
• Omaveloxolon

• Onasemnogene abeparvovec

  • Patients up to 18 years of age with 5q spinal muscular atrophy (SMA) SMA type 1, 2 and 3 or with 1-4 copies of the SMN2-gene.
• Opakalim

• Pridopidine

  • Early stage Huntington Disease.
  • Amyotrophic lateral sclerosis (ALS)
• Psilocybine

• Ranibizumab

  • Treatment of neovascular age-related macular degeneration (AMD).
• Revakinagene Taroretcel
• Ripasudil
• Rozanolixizumab ^IND
• Seltorexant
• Soclenicant
• Sonpiretigene Isteparvovec
• Sufentanil / ketamine

• Sugammadex

  • Extension of indication to include treatment the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.
• Tanruprubart
• Tarcocimab tedromer

• Tasimelteon

  • Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS).
• Timbetasine acetaat
• Tinlarebant

• Tiratricol

  • Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
• Tolebrutinib
• Trofinetide
• Troriluzol
• Ulixacaltamide
• Valiltramiprosate

• Vamorolone

  • Extension of indication to include treatment of 2 to <4 year olds with Duchenne muscular dystrophy (DMD)
• Vatiquinone

• Vutrisiran

  • Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
• Zilganersen
• Zilucoplan
• Zonisamide ^IND
• Zuranolone

Cardiovascular diseases

• Acoramidis
• Aficamten
• Anselamimab
• Apadamtase alfa
• Asundexian
• Baxdrostat

• Benralizumab

  • Extension of indication to include treatment of adults and adolescents with hypereosinophilic syndrome (HES).

• Concizumab

  • Routine prophylaxis of bleeding in patients with; haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more; haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
  • Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without FVIII inhibitors and moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤2%) without FIX inhibitors
• Crovalimab

• Damoctocog alfa pegol

  • Treatment and prophylaxis of bleeding in previously treated patients ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency).
• Danicopan
• Denecimig
• Edaravone / dexborneol

• Eltrombopag

  • Extension of indication to include second-line treatment of paediatric patients aged 2 years and above with acquired severe aplastic anaemia (SAA).
• Enlicitide decanoate
• Etavopivat
• Etranacogene dezaparvovec
• Etripamil

• Evinacumab

  • Extension of indication for EVKEEZA to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia aged 6 months to less than 5 years.
• Exagamglogene autotemcel
• Ferrimaltol ^IND

• Finerenon

  • Extension of indication to include the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.
• Giroctocogene fitelparvovec
• Glutathione Sodium
• Inclacumab

• Inclisiran

  • Extension of indication to include the treatment of paediatric patients aged 12 to less than 18 years with homozygous or heterozygous familial hypercholesterolaemia (HoFH/HeFH).

• Lerodalcibep

  • Is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet.
  • Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy with history of CVD, monotherapy for add-on treatment.
• Lomitapide ^IND
• Lorundrostat

• Marstacimab

  • Routinematige profylactische behandeling van bloedingen bij patiënten twaalf jaar en ouder met ernstige hemofilie A en B zonder remmers
  • Routinematige profylactische behandeling van bloedingen bij patiënten twaalf jaar en ouder met ernstige hemofilie A en B met remmers

• Mavacamten

  • Mavacamten for treatment of symptomatic (NYHA class II or III) non-obstructive hypertrophic cardiomyopathy in adults.

• Mitapivat

  • Pyrukynd is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia
  • Mitapivat monotherapy for treatment of pyruvate kinase deficiency anaemia in infants and toddlers over 1 year of age, children and adolescents who are not regularly receiving blood transfusion.
• Mozafancogene autotemcel
• Neoatricon (dopamine)
• Obicetrapib
• Obicetrapib / ezetimibe

• Olezarsen

  • Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
  • Olezarsen monotherapy for add-on treatment of severe hypertriglyceridemia in adults and elderly.

• Pegcetacoplan

  • Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemi.
• Pegozafermine
• Pelacarsen
• Plozasiran
• Pozelimab
• Rilzabrutinib
• Rusfertide
• Selatogrel
• Seralutinib

• Tirzepatide

  • Extension of indication to include treatment of symptomatic chronic heart failure with preserved ejection fraction (HFpEF) in adults with obesity.

• Turoctocog alfa pegol

  • Extension of indication to include children below 12 years of age for treatment and prophylaxis of bleeding with haemophilia A for Esperoct, including previously untreated patients (PUPs).
• Valoctocogene roxaparvovec

• Vericiguat

  • Extension of indication for treatment of symptomatic chronic Heart failure with reduced ejection fraction in adults and elderly who have not had a recent hospitalization for heart failure or need for outpatient intravenous diuretics.
  • Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy

• Vonicog alfa

  • Treatment of haemorrhage in children (aged less than 18 years) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

• Vutrisiran

  • Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
• Zalunfiban
• Ziltivekimab

Older publications

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• Published on 9 January 2018