Regulatory PathRegulatory requirements compared

Active substance

Nintedanib

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
NTARIBZ150 mgCapsule, soft · Oral use60 BlisterSAR 6833.45Generic · PrescriptionALPHA PHARMA INDUSTRYValid
NTARIBZ100 mgCapsule, soft · Oral use60 BlisterSAR 3490.50Generic · PrescriptionALPHA PHARMA INDUSTRYValid
Nintib100 mgCapsule · Oral use60 BottleSAR 3759.00Generic · PrescriptionBoston Oncology ArabiaValid
Nintib150 mgCapsule · Oral use60 BottleSAR 7359.10Generic · PrescriptionBoston Oncology ArabiaValid
OFEV 100 mg Soft Capsule100 mgCapsule · Oral use60 BlisterSAR 5370.35NCE · PrescriptionBOEHRINGER INGELHEIMValid
OFEV 150 mg Soft Capsule150 mgCapsule · Oral use60 BlisterSAR 10513.00NCE · PrescriptionBOEHRINGER INGELHEIMValid

EMA European Union — centrally authorised medicines

Vargatef Boehringer Ingelheim International GmbH · Authorised · authorised 21 Nov 2014 · ATC L01EX09

Therapeutic indication (EMA)

Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.

Ofev Boehringer Ingelheim International GmbH · Authorised · authorised 14 Jan 2015 · ATC L01EX09

Therapeutic indication (EMA)

Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Nintedanib Accord Accord Healthcare S.L.U. · Authorised · authorised 19 Apr 2024 · ATC L01EX09

Therapeutic indication (EMA)

Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).

Nintedanib Viatris Viatris Limited · Authorised · authorised 22 Aug 2025 · ATC L01EX09

Therapeutic indication (EMA)

Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). 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).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-NINTEDANIB02526891100 MGCAPSULE · ORALAURO PHARMA INC
AURO-NINTEDANIB02526905150 MGCAPSULE · ORALAURO PHARMA INC
JAMP NINTEDANIB02540762150 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP NINTEDANIB02550849100 MGCAPSULE · ORALJAMP PHARMA CORPORATION
OFEV02443066100 MGCAPSULE · ORALBOEHRINGER INGELHEIM (CANADA) LTD LTEE
OFEV02443074150 MGCAPSULE · ORALBOEHRINGER INGELHEIM (CANADA) LTD LTEE

Safety signals and safety-related labeling changes

All safety entries for nintedanib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.