RIULVY Gastro-resistant capsule, hard Ref.[115780] Active ingredients:

Source: European Medicines Agency (EU)  Revision Year: 2025 

Product name and form

RIULVY 174 mg gastro-resistant hard capsules.

RIULVY 348 mg gastro-resistant hard capsules.

Pharmaceutical Form

Gastro-resistant capsule, hard.

174 mg gastro-resistant capsules, hard: Light blue and white gastro-resistant hard gelatin capsules, size 0 with the dimension of approximately 21 mm, printed with '174' in white ink on body, containing pale yellow mini tablets.

348 mg gastro-resistant capsules, hard: Light blue gastro-resistant hard gelatin capsules, size 00 with the dimension of approximately 24 mm, printed with '348' in white ink on body, containing pale yellow mini tablets.

Qualitative and quantitative composition

RIULVY 174 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 174.2 mg tegomil fumarate (174 mg tegomil fumarate corresponds to 120 mg dimethyl fumarate).

RIULVY 348 mg gastro-resistant hard capsules: Each gastro-resistant hard capsule contains 348.4 mg tegomil fumarate (348 mg tegomil fumarate corresponds to 240 mg dimethyl fumarate).

For the full list of excipients, see section 6.1.

List of Excipients

Capsule contents (enteric-coated minitablets):

Microcrystalline cellulose (E460i)
Croscarmellose sodium (E466)
Talc
Silica, colloidal anhydrous
Magnesium stearate (E470b)
Hypromellose (E464)
Hydroxypropylcellulose (E463)
Titanium dioxide (E171)
Triethyl citrate (E1505)
Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%
Poly(vinyl alcohol) (E1203)
Macrogol
Iron oxide, yellow (E172)

Capsule shell:

Gelatin (E428)
Titanium dioxide (E171)
Brilliant Blue FCF (E133)

Capsule print (white ink):

Shellac
Potassium hydroxide
Titanium dioxide (E171)
Propylene glycol (E1520)

Pack sizes and marketing

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