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/1/00/156 · toegelaten op 28-12-2000 · Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults (see section… · ViiV Healthcare BV · abacavir, lamivudine, zidovudine · ATC J05AR02
nr. EU/1/22/1695 · toegelaten op 20-12-2022 · Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse l… · Swedish Orphan Biovitrum AB (publ) · loncastuximab tesirine · ATC L01FX22
nr. EU/1/24/1801 · toegelaten op 19-04-2024 · Plaque psoriasis
Pyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in adults who… · Samsung Bioepis NL B.V. · ustekinumab · ATC L04AC05
nr. EU/1/18/1282 · toegelaten op 16-05-2018 · Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who a… · ViiV Healthcare B.V. · dolutegravir / rilpivirine · ATC J05AR21
nr. EU/1/11/708 · toegelaten op 18-08-2011 · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
nr. EU/1/20/1508 · toegelaten op 18-01-2021 · <u>Breast cancer</u>
<i>HER2-positive breast cancer</i>
<u>Early breast cancer</u>
Enhertu as monothera… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
nr. EU/1/18/1352 · toegelaten op 15-02-2019 · Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic sple… · AOP Orphan Pharmaceuticals GmbH · ropeginterferon alfa-2b · ATC L03AB15
nr. EU/1/15/1004 · toegelaten op 27-05-2015 · Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 yea… · Hikma Farmacêutica (Portugal), S.A. · voriconazole · ATC J02AC03
nr. EU/1/22/1675 · toegelaten op 23-08-2022 · TECVAYLI is indicated
• in combination with daratumumab for the treatment of adult patients with relapsed or… · Janssen-Cilag International NV · teclistamab · ATC L01F
nr. EU/1/14/934 · toegelaten op 18-07-2014 · Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis · Biogen Netherlands B.V. · peginterferon beta-1a · ATC L03AB13
nr. EU/1/98/082 · toegelaten op 16-09-1998 · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
nr. EU/1/11/698 · toegelaten op 13-07-2011 · Melanoma
YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced … · Bristol-Myers Squibb Pharma EEIG · ipilimumab · ATC L01FX04
nr. EU/1/21/1576 · toegelaten op 22-11-2021 · BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia… · BeOne Medicines Netherlands B.V. · zanubrutinib · ATC L01EL03
nr. EU/1/21/1571 · toegelaten op 20-08-2021 · Abiraterone Mylan is indicated with prednisone or prednisolone for:
• the treatment of newly diagnosed meta… · Mylan Pharmaceuticals Limited · abiraterone acetate · ATC L02BX03
nr. EU/1/01/198 · toegelaten op 27-08-2001 · Glivec is indicated for the treatment of
- adult and paediatric patients with newly diagnosed Philadelphia ch… · Novartis Europharm Limited · Imatinib · ATC L01EA01
nr. EU/1/20/1441 · toegelaten op 30-05-2020 · Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age… · Novartis Europharm Limited · indacaterol / mometasone furoate · ATC R03AK
nr. EU/1/18/1286 · toegelaten op 26-07-2018 · <u>Rheumatoid arthritis</u>
Hyrimoz in combination with methotrexate, is indicated for:
• the treatment … · Sandoz GmbH · adalimumab · ATC L04AB04
nr. EU/1/14/980 · toegelaten op 15-01-2015 · Adult plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adul… · Novartis Europharm Limited · secukinumab · ATC L04AC10
nr. EU/1/06/336 · toegelaten op 24-04-2006 · Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following … · Pfizer Europe MA EEIG · Tigecycline · ATC J01AA12
nr. EU/1/08/442 · toegelaten op 18-03-2008 · Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total h… · Boehringer Ingelheim International GmbH · dabigatran etexilate mesilate · ATC B01AE07
nr. EU/1/07/418 · toegelaten op 18-09-2007 · CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced… · ViiV Healthcare BV · maraviroc · ATC J05AX09
nr. EU/1/09/600 · toegelaten op 30-11-2009 · Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one w… · Biotest Pharma GmbH · Human Hepatitis B Immunoglobulin · ATC J06BB04
nr. EU/1/25/1974 · toegelaten op 22-12-2025 · WAYRILZ is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory t… · Sanofi B.V. · rilzabrutinib · ATC Pending
nr. EU/1/22/1645 · toegelaten op 25-04-2022 · Vydura is indicated for the
• Acute treatment of migraine with or without aura in adults;
• Preventive trea… · Pfizer Europe MA EEIG · rimegepant · ATC N02CD
nr. EU/1/20/1481 · toegelaten op 17-12-2020 · Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunod… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
nr. EU/1/20/1452 · toegelaten op 25-06-2020 · Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and in… · Bristol-Myers Squibb Pharma EEIG · luspatercept · ATC B03XA06
nr. EU/1/17/1191 · toegelaten op 08-05-2017 · Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who ha… · Recordati Netherlands B.V. · dinutuximab beta · ATC L01FX06
nr. EU/1/15/1024 · toegelaten op 17-07-2015 · Melanoma
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and o… · Merck Sharp & Dohme B.V. · pembrolizumab · ATC L01FF02
nr. EU/1/18/1337 · toegelaten op 11-01-2019 · This medicinal product is for diagnostic use only.
GHRYVELIN is indicated for the diagnosis of growth hormone… · Atnahs Pharma Netherlands B.V. · macimorelin · ATC V04CD06
nr. EU/1/20/1508 · toegelaten op 18-01-2021 · <u>Breast cancer</u>
<i>HER2-positive breast cancer</i>
Enhertu in combination with pertuzumab is indicate… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
nr. EU/1/97/053 · toegelaten op 17-11-1997 · Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confir… · Sanofi B.V. · imiglucerase · ATC A16AB02
nr. EU/1/24/1851 · toegelaten op 19-09-2024 · Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults and adolescen… · LEO Pharma A/S · delgocitinib · ATC D11AH11
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/1/17/1231 · toegelaten op 08-01-2018 · Ocrevus is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with … · Roche Registration GmbH · ocrelizumab · ATC L04AG08
nr. EU/1/11/676 · toegelaten op 17-03-2011 · JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with m… · Sanofi Winthrop Industrie · cabazitaxel · ATC L01CD04
nr. EU/1/24/1872 · toegelaten op 12-12-2024 · Adult Crohn’s disease
IMULDOSA is indicated for the treatment of adult patients with moderately to severely … · Accord Healthcare S.L.U. · ustekinumab · ATC L04AC05
nr. EU/1/23/1760 · toegelaten op 15-09-2023 · Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce th… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
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