ℹ️ Compiled from public regulatory records · Last regulator revision: April 24, 2026🚩 Report this page

Osimertinib

Epidermal Growth Factor Receptor (Egfr) Tyrosine Kinase Inhibitors

Sold as TAGRISSO

GB MHRACA Health CanadaEU EMA

Drug class: Epidermal Growth Factor Receptor (Egfr) Tyrosine Kinase Inhibitors
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 11

L01EBEpidermal Growth Factor Receptor (Egfr) Tyrosine Kinase Inhibitors

Overview

Osimertinib is an active pharmaceutical ingredient in the Epidermal Growth Factor Receptor (Egfr) Tyrosine Kinase Inhibitors group (L01EB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	8	April 24, 2026
CA Canada	Health Canada	2	May 21, 2025
EU European Union	EMA	1	January 19, 2026

GBUnited Kingdom· MHRA

8 products

Uses

GBOfficial regulatory label· revised April 24, 2026[1]

1). • the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
• the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. TAGRISSO is indicated in combination with: • pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

How to take

CACanada· Health Canada

2 products

Uses

CAOfficial regulatory label· revised May 21, 2025[2]

4 Geriatrics 06/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 5 Missed Dose....................................................................................................
10 5 OVERDOSAGE .......................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 10 7 WARNINGS AND PRECAUTIONS .............................................................................
1 Special Populations ......................................................................................... 1 Pregnant Women ........................................................................................ 2 Breast-feeding.............................................................................................
3 Pediatrics.................................................................................................... 4 Geriatrics .................................................................................................... 18 8 ADVERSE REACTIONS .............................................................................................

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 19, 2026[3]

1). • the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
3 • the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation- positive NSCLC. TAGRISSO is indicated in combination with: • pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

How to take

Drug interactions

Known interactions involving Osimertinib. Select one for details. This list is informational and not a complete interaction checker.

Abarelix Abiraterone Adalimumab Adenosine Alfuzosin Amiodarone Amisulpride Amitriptyline Amoxapine Amprenavir Anagrelide Apalutamide Apomorphine Arsenic Trioxide Asenapine Atazanavir Atomoxetine Azithromycin Baricitinib Bedaquiline Bepridil Berotralstat Bicalutamide Boceprevir Bosutinib Buprenorphine Cabozantinib Carbamazepine Ceritinib Certolizumab Pegol Chloroquine Chlorpromazine Cilostazol Cisapride Citalopram Cladribine Clarithromycin Clofazimine Clomipramine Clozapine Cobicistat Conivaptan Crizotinib Dasatinib Daunorubicin Deferiprone Degarelix Delavirdine Desipramine Deutetrabenazine Disopyramide Dofetilide Dolasetron Doxepin Doxorubicin Dronedarone Droperidol Efavirenz Encorafenib Entrectinib Enzalutamide Epirubicin Eribulin Erythromycin Escitalopram Etanercept Ezogabine Fingolimod Flecainide Fluconazole Fluoxetine Fluphenazine Flutamide Fosamprenavir Foscarnet Fosphenytoin Fostemsavir Gatifloxacin Gemifloxacin Gilteritinib Glasdegib Golimumab Goserelin Granisetron Grepafloxacin Halofantrine Haloperidol Halothane Histrelin Hydroxychloroquine Hydroxyzine Ibutilide Idarubicin Idelalisib Iloperidone Imipramine Indinavir Infliximab Inotuzumab Ozogamicin Isoproterenol Itraconazole Ivabradine Ivosidenib Ketoconazole Lapatinib Lefamulin Leflunomide Lenvatinib Leuprolide Levofloxacin Lisdexamfetamine Lithium Carbonate Lofexidine Lomefloxacin Lonafarnib Lumacaftor Lumefantrine Macimorelin Maprotiline Mefloquine Mesoridazine Metaproterenol Methadone Methotrimeprazine Midostaurin Mifepristone Mirtazapine Mitotane Moxifloxacin Natalizumab Nefazodone Nelfinavir Nilotinib Nilutamide Norfloxacin Nortriptyline Ofloxacin Oliceridine Ondansetron Osilodrostat Oxaliplatin Oxytocin Ozanimod Paliperidone Palonosetron Panobinostat Papaverine Pasireotide Pazopanib Pentamidine Perflutren Perphenazine Phenobarbital Phenytoin Pimavanserin Pimozide Pitolisant Posaconazole Primaquine Primidone Probucol Procainamide Prochlorperazine Promazine Promethazine Propafenone Propoxyphene Protriptyline Quetiapine Quinidine Quinine Ranolazine Relugolix Ribociclib Rifabutin Rifampin Rifapentine Rilpivirine Risperidone Ritodrine Ritonavir Romidepsin Rucaparib Saquinavir Selpercatinib Sertraline Sevoflurane Siponimod Solifenacin Sorafenib Sotalol Sparfloxacin Sunitinib Tamoxifen Telaprevir Telavancin Telithromycin Terbutaline Teriflunomide Tetrabenazine Thioridazine Tofacitinib Toremifene Tramadol Trazodone Triclabendazole Trifluoperazine Triflupromazine Trimeprazine Trimipramine Triptorelin Troleandomycin Tucatinib Upadacitinib Valbenazine Vandetanib Vardenafil Vemurafenib Venlafaxine Voriconazole Ziprasidone Abametapir Abemaciclib Afatinib Albuterol Alefacept Alemtuzumab Alfentanil Alosetron Alpelisib Aminoglutethimide Amobarbital Anakinra Aprepitant Arformoterol Aripiprazole Armodafinil Artesunate Astemizole Azathioprine

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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB179010341 · revised April 24, 2026
[2]Health Canada (DPD) · 02456214 · revised May 21, 2025
[3]European Medicines Agency · EMEA/H/C/004124 · revised January 19, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

CACanada· Health Canada

EUEuropean Union· EMA

Drug interactions

Drugs in the same class

Sources & citations