Nintedanib
Other Protein Kinase Inhibitors
Sold as OFEV · Vargatef
- Drug class
- Other Protein Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 43
Overview
Nintedanib is an active pharmaceutical ingredient in the Other Protein Kinase Inhibitors group (L01EX). 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 | 31 | May 22, 2026 |
| CA Canada | Health Canada | 8 | May 13, 2026 |
| EU European Union | EMA | 4 | May 8, 2026 |
GBUnited Kingdom· MHRA
31 products
Uses
Nintedanib is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 1). Nintedanib is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
How to take
CACanada· Health Canada
8 products
Uses
JAMP
Nintedanib (nintedanib) capsules are indicated for: • The treatment of Idiopathic Pulmonary Fibrosis (IPF) • To slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) • The treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD) (see 14 CLINICAL TRIALS).
1 Pediatrics • Pediatrics (< 18 years of age): The safety and efficacy of nintedanib in pediatric patients have not been studied in clinical trials and therefore, JAMP Nintedanib should not be used in patients under 18 years of age.
2 Geriatrics • Geriatrics (> 65 years of age): No dose adjustment is necessary in patients 65 years and older.
EUEuropean Union· EMA
4 products
Uses
Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 1). 1). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
3
How to take
Drug interactions
Known interactions involving Nintedanib. Select one for details. This list is informational and not a complete interaction checker.
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) · PL045691882 · revised May 22, 2026
- [2]Health Canada (DPD) · 02540762 · revised May 13, 2026
- [3]European Medicines Agency · EMEA/H/C/006486 · revised May 8, 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.