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nintedanib

Ofev, Vargatef · ATC code L01EX09

Brand names: Ofev, Vargatef, Nintedanib Cipla, Nintedanib Reddy, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nipfilan, Puqod, Nintwel, Genadib

Key facts
Active substance
nintedanib
ATC code
L01EX09
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ofev 25 mg soft capsules / Ofev 100 mg soft capsules / Ofev 150 mg soft capsules · Vargatef 100 mg soft capsules / Vargatef 150 mg soft capsules
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Information as of
2026-10-27

Key facts

Nintedanib is a tyrosine kinase inhibitor used for fibrosing interstitial lung diseases (Ofev) and, with docetaxel, for non-small cell lung cancer (Vargatef).

What it is used for

  • Ofev: idiopathic pulmonary fibrosis (IPF) in adults
  • Ofev: other chronic progressive fibrosing ILDs in adults; clinically significant progressive fibrosing ILDs in children aged 6 to 17
  • Ofev: systemic sclerosis associated ILD from 6 years
  • Vargatef: with docetaxel for adenocarcinoma NSCLC after first-line chemotherapy

Dosing

  • Ofev, adults: 150 mg twice daily approximately 12 hours apart; 100 mg twice daily only if 150 mg is not tolerated; maximum 300 mg daily.
  • Ofev, children 6 to 17 years: weight-based dose twice daily (table in the full text).
  • Vargatef: 200 mg twice daily on days 2 to 21 of the 21 day docetaxel cycle, not on the day of docetaxel; maximum 400 mg daily.
  • For adverse reactions interrupt and reduce dose; discontinue if 100 mg twice daily is not tolerated.
  • Mild hepatic impairment: reduced dose; moderate or severe not recommended.

Contraindications

  • Hypersensitivity to nintedanib, to peanut or soya, or any excipient
  • Ofev: pregnancy

Important warnings

  • Diarrhoea, sometimes serious with dehydration; treat early with hydration and anti-diarrhoeals (e.g. loperamide)
  • Nausea and vomiting; dose reduction or interruption may be needed
  • Drug-induced liver injury, including fatal cases; check liver tests before and during treatment
  • Bleeding risk
  • Children: monitor growth and dental development regularly

Side effects

  • Most frequent: diarrhoea, nausea, vomiting, abdominal pain
  • Decreased appetite, weight decreased, hepatic enzyme increased
  • Common: headache, bleeding
  • Uncommon: thrombocytopenia, myocardial infarction

Interactions

  • Potent P-gp inhibitors (e.g. ketoconazole, erythromycin): higher nintedanib exposure; monitor tolerability closely
  • Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John's Wort): reduced exposure

Pregnancy and breastfeeding

  • May cause foetal harm; highly effective contraception until at least 3 months after the last dose.
  • Vomiting or diarrhoea may reduce the efficacy of oral hormonal contraceptives.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Nintedanib Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/006179
  • Nintedanib Viatris · genericViatris Limited · EMEA/H/C/006486
  • OfevBoehringer Ingelheim International GmbH · EMEA/H/C/003821
  • VargatefBoehringer Ingelheim International GmbH · EMEA/H/C/002569

Source: European Medicines Agency (EMA), product information

Austria

  • Nintedanib CiplaCipla Europe Nv · 1 register entry
  • Nintedanib ReddyReddy Holding Gmbh · 1 register entry
  • Nintedanib SandozSandoz Gmbh · 1 register entry
  • Nintedanib StadaStada Arzneimittel Gmbh · 1 register entry
  • Nintedanib TevaRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
  • NipfilanG.L. Pharma Gmbh · 1 register entry
  • PuqodZentiva, K.S. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • NintedanibEugia Pharma (Malta) Limited, 1 A Pharma Gmbh, Accord Healthcare B.V., Ratiopharm Gmbh, Laboratorio Reig Jofré, S.A., Stadapharm Gmbh, Tillomed Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Aliud Pharma Gmbh, Cipla Europe Nv, Hexal Ag, Olpha As, Betapharm Arzneimittel Gmbh · 17 register entries
  • NintwelOranda Therapeutics Limited · 1 register entry
  • NipfilanG.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • GenadibGENVEON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • OfevBOEHRİNGER INGELHEİM İLAÇ TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 26 more European countries
Belgium
Nintedanib Accordpharma, Nintedanib Eg, Nintedanib Eugia, Nintedanib Eurogenerics, Nintédanib Eg (Eurogenerics)
Croatia
Gevesla, Nintedanib Accordpharma, Nintedanib Devatis, Nintedanib Onkogen, Nintedanib Pliva, Nintedanib Stada, Nintedanibesilat Stada D.O.O.
Czechia
Nintedanib Glenmark, Nintedanib Sandoz, Puqod
Denmark
Nintedanib "sandoz", Nintedanib Glenmark, Nintedanib Newbury, Nintedanib Stada, Nintedanib Zentiva
Estonia
Agarf, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Zentiva, Nytyka
Finland
Nintedanib Devatis, Nintedanib Glenmark, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Zentiva
France
Nintedanib Arrow, Nintedanib Biogaran, Nintedanib Cipla, Nintedanib Eg, Nintedanib Intas, Nintedanib Sandoz, Nintedanib Zentiva
Greece
Nifib, Nindraf, Nintedanib Ahcl, Nintedanib Sandoz, Nintedanib Stada
Hungary
Nintedanib Accordpharma, Nintedanib Onkogen, Nintedanib Ratiopharm, Nintedanib Sandoz
Iceland
Agarf, Nintedanib Accord, Nintedanib Adalvo, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Viatris, Nintedanib Zentiva, Nipfilan, Nytyka, Ofev, Puqod, Vargatef
Ireland
Nintedanib Accordpharma, Nintedanib Clonmel, Nintedanib Norton, Nintedanib Teva
Italy
Nintedanib Accordpharma, Nintedanib Aurobindo, Nintedanib Cipla, Nintedanib Dr. Reddy’s, Nintedanib Eg, Nintedanib Glenmark, Nintedanib Intas, Nintedanib Sandoz, Nintedanib Teva, Nipfilan, Puqod
Latvia
Agarf, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Zentiva
Liechtenstein
Nintedanib Accord, Nintedanib Viatris, Ofev, Vargatef
Lithuania
Agarf, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Zentiva, Nytyka
Luxembourg
Nintedanib Eg, Nintedanib Eurogenerics
Malta
Nifiden Adalvo, Nintedanib Adalvo, Nintedanib Clonmel, Nintedanib Lotus
Netherlands
Gevesla, Nintedanair, Nintedanib, Nintwel
Norway
Nintedanib Accord, Nintedanib Devatis, Nintedanib Glenmark, Nintedanib Newbury, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Viatris, Ofev, Vargatef
Poland
Nintedanib
Portugal
Nintedanib Accordpharma, Nintedanib Eugia, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Zidrium Teva
Romania
Gevesla, Nintedanib Dr. Reddy’s, Nintedanib Stada, Nintedanib Teva, Puqod
Slovakia
Nintedanib Stada, Nintedanib Teva, Puqod
Slovenia
Nintedanib Accordpharma, Nintedanib Stada, Nintedanib Teva
Spain
Nintedanib
Sweden
Nintedanib Devatis, Nintedanib Glenmark, Nintedanib Intas, Nintedanib Newbury, Nintedanib Reddy, Nintedanib Sandoz, Nintedanib Stada, Nintedanib Teva, Nintedanib Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Ofev – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ofev-epar-product-information_en.pdf
  2. European Medicines Agency. Vargatef – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/vargatef-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.