Bronnen: wij volgen de wijzigingen op basis van informatie van het College ter Beoordeling van Geneesmiddelen (CBG) — de Geneesmiddeleninformatiebank (inschrijvingen en doorgehaalde handelsvergunningen, dagelijks vergeleken) en DHPC-brieven — en van de Inspectie Gezondheidszorg en Jeugd (terugroepacties). Besluiten over centraal toegelaten geneesmiddelen komen uit het Uniebestand van de Europese Commissie (EU-label). Voor tekorten en vergoedingen bestaan in Nederland geen open overheidsgegevens; die staan hier (nog) niet. Alternatieven met dezelfde werkzame stof: database van Lekoskop.
nr. EU/1/16/1156 · toegelaten op 18-01-2017 · ZINPLAVA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in adult an… · Merck Sharp & Dohme B.V. · bezlotoxumab · ATC J06BC03
nr. EU/1/19/1409 · toegelaten op 19-12-2019 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · Mundipharma Corporation (Ireland) Limited · pegfilgrastim · ATC L03AA13
nr. EU/1/24/1887 · toegelaten op 13-01-2025 · Baiama is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD… · Formycon AG · Aflibercept · ATC S01LA05
nr. EU/1/25/1957 · toegelaten op 14-08-2025 · Adult Crohn’s Disease
Usymro is indicated for the treatment of adult patients with moderately to severely ac… · Gedeon Richter Plc. · ustekinumab · ATC L04AC05
nr. EU/1/10/638 · toegelaten op 27-07-2010 · OZURDEX is indicated for the treatment of adult patients with:
• Visual impairment due to diabetic macular oe… · AbbVie Deutschland GmbH & Co. KG · dexamethasone · ATC S01BA01
nr. EU/1/23/1732 · toegelaten op 31-05-2023 · Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secon… · Extrovis EU Kft. · lacosamide · ATC N03AX18
nr. EU/1/15/1064 · toegelaten op 16-12-2015 · Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly me… · Amgen Europe B.V. · talimogene laherparepvec · ATC L01XL02
nr. EU/1/25/2006 · toegelaten op 12-02-2026 · Aumseqa as monotherapy is indicated for:
• the first line treatment of adult patients with advanced non small… · SFL Pharmaceuticals Deutschland GmbH · aumolertinib · ATC L01EB11
nr. EU/1/21/1615 · toegelaten op 13-04-2022 · <u>Muscle invasive bladder cancer (MIBC)</u>
Padcev, in combination with pembrolizumab, as neoadjuvant trea… · Astellas Pharma Europe B.V. · enfortumab vedotin · ATC L01FX13
nr. EU/1/24/1833 · toegelaten op 25-07-2024 · Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults wi… · CStone Pharmaceuticals Ireland Limited · sugemalimab · ATC L01FF11
nr. EU/1/21/1608 · toegelaten op 06-01-2022 · Adults
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for wei… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
nr. EU/1/23/1770 · toegelaten op 07-12-2023 · ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple… · Pfizer Europe MA EEIG · elranatamab · ATC L01FX32
nr. EU/1/21/1599 · toegelaten op 24-01-2022 · VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. · H. Lundbeck A/S · eptinezumab · ATC N02CD05
nr. EU/1/13/821 · toegelaten op 13-03-2013 · Treatment of essential hypertension. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochloroth… · KRKA d d., Novo mesto · telmisartan/hydrochlorothiazide · ATC C09DA07
nr. EU/1/16/1152 · toegelaten op 20-04-2017 · Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with … · Berlin-Chemie AG · edoxaban · ATC B01AF03
nr. EU/1/09/586 · toegelaten op 30-11-2009 · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
nr. EU/1/22/1684 · toegelaten op 15-09-2022 · NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. · Integral Pharma Solutions EU Limited · fosdenopterin · ATC A16AX
nr. EU/1/25/1964 · toegelaten op 18-08-2025 · MYNZEPLI is indicated for adults for the treatment of
- neovascular (wet) age-related macular degeneration (A… · Advanz Pharma Limited · aflibercept · ATC S01LA05
nr. EU/1/20/1468 · toegelaten op 21-08-2020 · Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF… · Vertex Pharmaceuticals (Ireland) Limited · ivacaftor / tezacaftor / elexacaftor · ATC R07AX32
nr. EU/1/12/780 · toegelaten op 20-07-2012 · Jentadueto is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve … · Boehringer Ingelheim International GmbH · linagliptin/metformin hydrochloride · ATC A10BD11
nr. EU/1/23/1723 · toegelaten op 15-05-2023 · Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adu… · Plusultra pharma GmbH · sirolimus · ATC L01EG04
nr. EU/1/09/594 · toegelaten op 30-11-2009 · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
nr. EU/1/16/1146 · toegelaten op 11-11-2016 · Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and ol… · Boehringer Ingelheim International GmbH · empagliflozin/linagliptin · ATC A10BD19
nr. EU/1/25/1972 · toegelaten op 15-09-2025 · Eyluxvi is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Biolitec Pharma Limited Zweigniederlassung Jena · aflibercept · ATC S01LA05
nr. EU/1/20/1438 · toegelaten op 03-07-2020 · Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately control… · Novartis Europharm Limited · indacaterol / glycopyrronium bromide / mometasone · ATC R03AL12
nr. EU/1/22/1700 · toegelaten op 16-12-2022 · Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older wi… · Pierre Fabre Medicament · Tabelecleucel · ATC L01XL09
nr. EU/1/26/2030 · toegelaten op 06-05-2026 · For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of nor… · Sandoz GmbH · Insulin lispro · ATC A10AB04
nr. EU/1/25/1965 · toegelaten op 18-08-2025 · Afiveg is indicated for adults for the treatment of
- neovascular (wet) age-related macular degeneration (AMD… · STADA Arzneimittel AG · aflibercept · ATC S01LA05
nr. EU/1/23/1751 · toegelaten op 15-09-2023 · Yesafili is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (… · Biosimilar Collaborations Ireland Limited · aflibercept · ATC S01LA05
nr. EU/1/23/1758 · toegelaten op 15-09-2023 · Non-small cell lung cancer (NSCLC)
Tevimbra, in combination with platinum-containing chemotherapy as neoadj… · BeOne Medicines Ireland Limited · tislelizumab · ATC L01FF09
nr. EU/1/20/1498 · toegelaten op 09-12-2020 · Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic ob… · AstraZeneca AB · Formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
nr. EU/1/21/1588 · toegelaten op 12-11-2021 · Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticl… · Viatris Limited · rivaroxaban · ATC B01AF01
nr. EU/1/21/1604 · toegelaten op 06-01-2022 · Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic … · AstraZeneca AB · formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
nr. EU/1/01/189 · toegelaten op 03-08-2001 · Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry… · Takeda Pharmaceuticals International AG Ireland Branch · Agalsidase alfa · ATC A16AB03
nr. EU/1/19/1404 · toegelaten op 16-12-2019 · Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthriti… · AbbVie Deutschland GmbH & Co. KG · upadacitinib · ATC L04AF03
nr. EU/1/25/1909 · toegelaten op 04-04-2025 · Pavblu is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Amgen Technology (Ireland) UC · Aflibercept · ATC S01LA05
nr. EU/1/24/1863 · toegelaten op 25-09-2024 · Adult Crohn’s disease
Otulfi is indicated for the treatment of adult patients with moderately to severely act… · Fresenius Kabi Deutschland GmbH · ustekinumab · ATC L04AC05
nr. EU/1/24/1865 · toegelaten op 13-11-2024 · Opuviz is indicated for adults for the treatment of
• neovascular (wet) age related macular degeneration (AMD… · Samsung Bioepis NL B.V. · Aflibercept · ATC S01LA05
nr. EU/1/18/1277 · toegelaten op 19-04-2018 · MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment … · Pfizer Europe MA EEIG · gemtuzumab ozogamicin · ATC L01FX02
nr. EU/1/22/1649 · toegelaten op 03-06-2022 · Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicula… · Roche Registration GmbH · mosunetuzumab · ATC L01FX25
nr. EU/1/23/1755 · toegelaten op 15-09-2023 · Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and… · Pfizer Europe MA EEIG · ritlecitinib · ATC L01EJ
nr. EU/1/19/1356 · toegelaten op 02-04-2019 · Rheumatoid arthritis
Idacio in combination with methotrexate, is indicated for:
the treatment of moderate… · Fresenius Kabi Deutschland GmbH · adalimumab · ATC L04AB04
nr. EU/1/24/1802 · toegelaten op 17-05-2024 · Paroxysmal nocturnal haemoglobinuria
FABHALTA is indicated as monotherapy in the treatment of adult patients … · Novartis Europharm Limited · iptacopan · ATC L04AJ08
nr. EU/1/12/797 · toegelaten op 22-11-2012 · Eylea 40 mg/mL :
Eylea is indicated for adults for the treatment of
• neovascular (wet) age-related macul… · Bayer AG · aflibercept · ATC S01LA05
nr. EU/1/25/1963 · toegelaten op 14-08-2025 · Eiyzey is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
nr. EU/1/15/1047 · toegelaten op 23-11-2015 · BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B c… · Amgen Europe B.V. · blinatumomab · ATC L01FX07
nr. EU/1/24/1888 · toegelaten op 13-01-2025 · Ahzantive is indicated for adults for the treatment of:
• neovascular (wet) age-related macular degeneration … · Formycon AG · Aflibercept · ATC S01LA05
nr. EU/1/24/1844 · toegelaten op 22-08-2024 · Adult Crohn’s Disease
Steqeyma is indicated for the treatment of adult patients with moderately to severely a… · Celltrion Healthcare Hungary Kft. · ustekinumab · ATC L04AC05
nr. EU/1/08/461 · toegelaten op 11-07-2008 · Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adol… · Takeda Pharmaceuticals International AG Ireland Branch · icatibant · ATC B06AC02
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