Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Jascayd 9 mg film-coated tablets.
Jascayd 18 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Jascayd 9 mg film-coated tablets: Light yellow, oval, biconvex, film-coated tablet debossed "F9" on one side and the Boehringer Ingelheim logo on the other (tablet length: 9.5 mm, tablet width: 4.6 mm). Jascayd 18 mg film-coated tablets: Light red, oval, biconvex film-coated tablet debossed with "F18" on one side and the Boehringer Ingelheim logo on the other (tablet length: 12 mm, tablet width: 5.9 mm). |
Each film-coated tablet contains 9 mg nerandomilast.
Excipient with known effect:
Each film-coated tablet contains 81.1 mg of lactose (as monohydrate).
Each film-coated tablet contains 18 mg nerandomilast.
Excipient with known effect:
Each film-coated tablet contains 162.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least nine-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C and PDE4D based on in vitro data. PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP). Nerandomilast exerts both anti-fibrotic and immunomodulatory effects as PDE4B inhibition elevates intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are overexpressed in IPF. |
| List of Excipients |
|---|
|
9 mg film-coated tablets: Lactose monohydrate 18 mg film-coated tablets: Lactose monohydrate |
PVC/aluminium perforated unit dose blisters.
Pack sizes of 10 × 1, 30 × 1, or 60 × 1 film-coated tablets.
HDPE bottle with a child-resistant closure.
Pack sizes of 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Jascayd 9 mg film-coated tablets:
EU/1/26/2040/001
EU/1/26/2040/002
EU/1/26/2040/003
EU/1/26/2040/004
EU/1/26/2040/005
Jascayd 18 mg film-coated tablets:
EU/1/26/2040/006
EU/1/26/2040/007
EU/1/26/2040/008
EU/1/26/2040/009
EU/1/26/2040/010
| Drug | Countries | |
|---|---|---|
| JASCAYD | United States |
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