Ofev Description

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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Full Prescribing Info

Description

Ofev 100 mg soft capsules: 1 capsule contains 100 mg of nintedanib (=free base) corresponding to 120.4 mg 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl] amino]phenyl] amino]phenylmethylene]-2-oxo-, methyl ester, (3Z)-, ethanesulfonate (1:1) (=nintedanib esilate).
Ofev 150 mg soft capsules: 1 capsule contains 150 mg of nintedanib (= free base) corresponding to 180.6 mg 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl] amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester, (3Z)-, ethanesulfonate (1:1) (= nintedanib esilate).
Excipients/Inactive Ingredients: Capsule fill: Medium chain triglycerides, hard fat, soya lecithin (E322).
Capsule shell: Gelatine, glycerol 85 %, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), black ink (Opacode).
Black ink: Shellac glaze, iron oxide black (E172), propylene glycol (E1520).

nintedanib

Manufacturer:

Boehringer Ingelheim