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/1/21/1579 · toegelaten op 24-06-2022 · Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of p… · Sanofi B.V. · avalglucosidase alfa · ATC A16AB22
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/1/16/1156 · 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/1/26/2062 · Zokovea is indicated for the post exposure prophylaxis of COVID 19 in adults and adolescents aged 12 years and… · Shionogi B.V. · ensitrelvir · ATC J05AE16
nr. EU/1/26/2055 · Ubeslo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or m… · A. Menarini International Licensing S.A. · Obicetrapib · ATC C10AX
nr. EU/1/26/2065 · Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with… · Accord Healthcare S.L.U. · tafamidis · ATC N07XX08
nr. EU/1/26/2064 · Myelofibrosis (MF)
Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or … · Viatris Limited · ruxolitinib · ATC L01EJ01
nr. EU/1/26/2051 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · QILU PHARMA SPAIN S.L. · pegfilgrastim · ATC L03AA13
nr. EU/1/26/2056 · Evlarco is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or … · A. Menarini International Licensing S.A. · obicetrapib / ezetimibe
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/1/26/2066 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · CuraTeQ Biologics s.r.o · Pegfilgrastim · ATC L03AA13
nr. EU/1/14/941 · toegelaten op 22-08-2014 · This medicinal product is for diagnostic use only.
VIZAMYL is a radiopharmaceutical indicated for Positron Em… · GE Healthcare AS · flutemetamol (18F) · ATC V09AX04
nr. EU/1/15/1079 · toegelaten op 15-02-2016 · Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the ag… · MCM Vaccine B.V. · Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) · ATC J07CA09
nr. EU/1/16/1135 · toegelaten op 15-09-2016 · Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3… · Proveca Pharma Limited · glycopyrronium bromide · ATC A03AB02
nr. EU/1/25/1947 · toegelaten op 28-07-2025 · RIULVY is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing … · Neuraxpharm Pharmaceuticals, S.L. · Tegomil fumarate · ATC L04AX10
nr. EU/1/23/1730 · toegelaten op 31-05-2023 · Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with… · Neuraxpharm Pharmaceuticals, S.L. · ublituximab · ATC L04AG14
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/1/05/312 · toegelaten op 13-10-2005 · Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years. · UCB Pharma S.A. · Sodium oxybate · ATC N07XX04
nr. EU/1/10/642 · toegelaten op 17-09-2010 · Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bon… · Teva B.V. · Ibandronic acid · ATC M05BA06
nr. EU/1/26/2060 · Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystr… · Minoryx Therapeutics S.L. · leriglitazone · ATC A16AX23
nr. EU/1/17/1175 · toegelaten op 22-03-2017 · Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
- Adult an… · Pfizer Europe MA EEIG · daptomycin · ATC J01XX09
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
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