JASCAYD Film-coated tablet Ref.[116755] Active ingredients: Nerandomilast

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

Product name and form

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).

Qualitative and quantitative composition

Jascayd 9 mg film-coated tablets

Each film-coated tablet contains 9 mg nerandomilast.

Excipient with known effect:

Each film-coated tablet contains 81.1 mg of lactose (as monohydrate).

Jascayd 18 mg film-coated tablets

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

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
Microcrystalline cellulose
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910
Talc
Mannitol
Macrogol 8000
Iron oxide yellow (E172)

18 mg film-coated tablets:

Lactose monohydrate
Microcrystalline cellulose
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate
Hypromellose 2910
Talc
Mannitol
Macrogol 8000
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
JASCAYD United States

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