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Overzicht van toekomstige innovatieve geneesmiddelen en verwachte indicatie-uitbreidingen voor alle domeinen.
Gepubliceerd op
Oncologie
- 177Lu-PNT2002
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Acalabrutinib
- Afamitresgene autoleucel
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Alectinib
- Amisulpride
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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.
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Apalutamide
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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
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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
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Cabozantinib
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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
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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.
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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
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Cemiplimab
- Ceralasertib
- Cetuximab sarotalocan
- Cobolimab
- Cosibelimab
- Cretostimogene grenadenorepvec
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Dabrafenib / trametinib
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Daratumumab
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Darolutamide
- Daromun
- Darovasertib
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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
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Denosumab
- Detalimogene voraplasmid
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Domvanalimab
- Dordaviprone
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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").
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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
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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.
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Enfortumab vedotin
- Ensartinib
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Entrectinib
- Fianlimab
- Furmonertinib
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Gedatolisib
- Gemcitabine IND
- Giredestrant
- Glufosfamide
- Hexaminolevulinate hydrochloride
- Imlunestrant
- Imsamotide
- Inavolisib
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Ipilimumab
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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
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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.
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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
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Lutetium (177Lu) oxodotreotide
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Lutetium (177lu) vipivotide tetraxetan
- MDM2-p53 antagonist
- Mevrometostat
- Mirdametinib
- Mirvetuximab soravtansine
- Mitomycine extended release
- Nadofaragene firadenovec
- Namodenoson
- Naxitamab
- Neladalkib
- Nemvaleukin alfa
- Nibrozeton
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Niraparib / abirateron
- Nirogacestat
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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
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Nogapendekin Alfa Inbakicept
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Nogapendekin alfa inbakicept
- OST31-164
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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
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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
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Paclitaxel
- Paclitaxel/hyaluronic acid
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Padeliporfin
- Palazestrant
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Palbociclib
- Patritumab deruxtecan
- Pegargiminase
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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
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Relacorilant
- Relatlimab / nivolumab
- Repotrectinib
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Retifanlimab
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Ribociclib
- Ripretinib
- Rosopatamab tetraxetan lutetium (177Lu)
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Rucaparib
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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
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Selinexor
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Selpercatinib
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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
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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
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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
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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
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Tebentafusp
- Temozolomide IND
- Tinengotinib
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Tiragolumab
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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
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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
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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
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Tucatinib
- 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).
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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
Hematologie
- ARI-0001
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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).
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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.
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Axicabtagene ciloleucel
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Belantamab mafodotin
- Belumosudil
-
Blinatumomab
-
Bosutinib
-
Brentuximab vedotin
-
Brexucabtagene autoleucel
-
Ciltacabtagene autoleucel
-
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
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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.
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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
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Gemtuzumab ozogamicin
-
Givinostat
-
Glofitamab
- Iberdomide
-
Ibrutinib
-
Idecabtagene vicleucel
- 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
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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
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Luspatercept
- 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.
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Mosunetuzumab
- 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
- 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
-
Tislelizumab
- Ziftomenib
Stofwisseling en Endocrinologie
-
Alpelisib
-
Arimoclomol
- Atidarsagene autotemcel IND
- Autologous human chondrocytes in vitro expanded
- BCAA-vrije aminozuren
-
Burosumab
-
Canagliflozine
- Carbetocine
- Clemidsogene lanparvovec
- Coördinatieverbinding van ijzercitraat
- Crinecerfont
-
Dasiglucagon
- Denatonium Acetate Monohydrate
- Dersimelagon
- Diazoxide choline (controlled-release tablet)
- Efzimfotase alfa
-
Elamipretide
- Eliglustat IND
- Elinzanetant
- Empagliflozine / metformine IND
- Encaleret
- Eneboparatide
- Ersodetug IND
- Estetrol
-
Etelcalcetide
- Glibenclamide IND
-
Glucagon
-
Govorestat
-
Hydrocortison
-
Infigratinib
- Insulin efsitora alfa
- Insulin icodec / semaglutide
- L-acetylleucine
- Leriglitazon
- Linerixibat
-
Linzagolix
-
Liraglutide
- Lonapegsomatropine IND
-
Maralixibat
-
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
- Paltusotine
- Pegunigalsidase alfa
-
Pegvaliase
-
Pegzilarginase
- Rebisufligene etisparvovec
-
Relacorilant
- Resmetirom
- Seladelpar
-
Semaglutide
- 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
-
Somatrogon
-
Sparsentan
- Teplizumab
- Teprotumumab
- Tiomolibdate choline
-
Tirzepatide
- Venglustat
- Vibegron
- Xylitol/l-carnitine/glucose
Chronische immuunziekten
- 13-grass pollen extract
-
Afamelanotide
- Allergeenextract huisstofmijt IND
-
Anifrolumab
- Apraglutide
- Arachis hypogaea (pinda) allergenen IND
- Atacicept
- Atrasentan
-
Baricitinib
-
Belimumab
- Beremagene geperpavec
-
Berotralstat
- Briquilimab
-
Budesonide
- Clascoterone
- Dapansutrile
-
Deucravacitinib
- 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
-
Etrasimod
-
Filgotinib
- 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
- Ianalumab
- Icotrokinra
-
Imlifidase
- Imsidolimab
-
Inebilizumab
-
Iptacopan
- Ivarmacitinib
-
Ixekizumab
-
Lebrikizumab
-
Leniolisib
- Lingolinurad
- Litifilimab
- Lonvoguran ziclumeran
-
Masitinib
- Mavorixafor
-
Minocycline
-
Mirikizumab
- Mycofenolaatmofetil IND
- Nemolizumab
- Obefazimod
-
Obinutuzumab
-
Pegcetacoplan
- 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
-
Roflumilast topicaal
-
Ruxolitinib (als fosfaat)
-
Sarilumab
- Sebetralstat
-
Secukinumab
- Secukinumab-bthr BS
- Sibeprenlimab
- Tadekinig alfa
-
Teduglutide
-
Tezepelumab
-
Tildrakizumab
- 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
- Veligrotug
- Zasocitinib
Infectieziekten
- Amikacine IND
-
Baloxavir marboxil
-
Bedaquiline
- Bio101
-
Bulevirtide
-
Casirivimab / imdevimab
- Ceftobiprole medocaril
- Clesrovimab
- Contezolid
-
Dalbavancine
-
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
- Doravirine / islatravir
- Emtricitabine/tenofovir alafenamide G
-
Ensitrelvir
-
Eravacycline
- Faecal microbiota transplant
- Funobactam
- Gepotidacin
-
Imipenem / Cilastatin / Relebactam
-
Isavuconazole
-
Lenacapavir
-
Letermovir
- Miconazole
-
Minocycline
- Nacubactam
- Nirmatrelvir / ritonavir IND
-
Nirsevimab
- Olorofim
- Pemivibart
- Pitavastatine
-
Posaconazol
-
Pretomanid
- Pritelivir
-
Remdesivir
-
Rilpivirine
- Sabizabulin
- Sipavibart
-
Tedizolid
- Vilobelimab
- Zoliflodacin
Longziekten algemeen
- ARINA-1
- Alpha-1 antitrypsin
-
Benralizumab
- Brensocatib
-
Ciclosporine
- Colistimethaatnatrium IND
- Depemokimab
-
Dupilumab
- Efzofitimod G
- Ensifentrine
- Exoflo Extracellular Vesicles
-
Formoterol / glycopyronium / budesonide
- Itepekimab
- Ivacaftor / Tezacaftor / Elexacaftor IND
-
Mepolizumab
- Nerandomilast
-
Nintedanib
-
Riociguat
-
Sotatercept
- Tanimilast
-
Tezepelumab
- Tozorakimab IND
-
Treprostinil
- Vanzacaftor / tezacaftor / deutivacaftor
Neurologische aandoeningen
- Acoltremon
- Adezunap
- Apitegromab
-
Atogepant
- Atropine sulfate IND
- Baclofen / naltrexone / sorbitol
- Basimglurant
- Bexicaserin
- Bidridistrogene xeboparvovec
- Bimatoprost
- Blarcamesine
- Botaretigene sparoparvovec
- Brexpiprazol IND
- Brimonidine tartrate/carbachol
-
Cannabidiol
- Casimersen
- Chloroprocaine IND
- Citicoline
- Condoliase
- Delandistrogene moxeparvovec
- Delpacibart zotadirsen
- Deramiocel
- Deutetrabenazine (extended release)
- Diflunisal
- Donanemab
- Doxecitine / doxiribtimine
- Ecopipam
- Efgartigimod alfa IND
- Empasiprubart
- Eplontersen
-
Eptinezumab
-
Fremanezumab
- Gefurulimab
-
Givinostat
- Gold Nanocrystals
- Hydromethylthionine mesylaat
- IBI311
- Ibudilast
- Iloperidon
- Incobotulinumtoxina
-
Inebilizumab
- Kyv-101
- Lecanemab
- Lenzumestrocel
-
Levodopa / carbidopa
-
Melatonine
- Meloxicam / rizatriptan
-
Mercaptamine
- Mexiletine IND
- Midazolam/ketamine
- Nepla-tem-cel
- Nipocalimab
-
Nusinersen
- OCU400
- Olanzapine (long-acting injectable)
- Omaveloxolon
-
Onasemnogene abeparvovec
- Opakalim
-
Pridopidine
- Psilocybine
-
Ranibizumab
- Revakinagene Taroretcel
- Ripasudil
- Rozanolixizumab IND
- Seltorexant
- Soclenicant
- Sonpiretigene Isteparvovec
- Sufentanil / ketamine
-
Sugammadex
- Tanruprubart
- Tarcocimab tedromer
-
Tasimelteon
- Timbetasine acetaat
- Tinlarebant
-
Tiratricol
- Tolebrutinib
- Trofinetide
- Troriluzol
- Ulixacaltamide
- Valiltramiprosate
-
Vamorolone
- Vatiquinone
-
Vutrisiran
- Zilganersen
- Zilucoplan
- Zonisamide IND
- Zuranolone
Cardiovasculaire aandoeningen
- Acoramidis
- Aficamten
- Anselamimab
- Apadamtase alfa
- Asundexian
- Baxdrostat
-
Benralizumab
-
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
- Danicopan
- Denecimig
- Edaravone / dexborneol
-
Eltrombopag
- Enlicitide decanoate
- Etavopivat
- Etranacogene dezaparvovec
- Etripamil
-
Evinacumab
- Exagamglogene autotemcel
- Ferrimaltol IND
-
Finerenon
- Giroctocogene fitelparvovec
- Glutathione Sodium
- Inclacumab
-
Inclisiran
-
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
-
Mavacamten
-
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
-
Pegcetacoplan
- Pegozafermine
- Pelacarsen
- Plozasiran
- Pozelimab
- Rilzabrutinib
- Rusfertide
- Selatogrel
- Seralutinib
-
Tirzepatide
-
Turoctocog alfa pegol
- 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
-
Vutrisiran
- Zalunfiban
- Ziltivekimab