ROPIQUAL XL Prolonged-release tablet Ref.[8424] Active ingredients: Ropinirole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

ROPIQUAL XL 2 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

2 mg prolonged-release tablets: pink, round biconvex tablets 6.8 ± 0.1 mm.

Qualitative and quantitative composition

Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride).

Excipients with known effect: 1.8 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ropinirole

Ropinirole is a non-ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors. Ropinirole alleviates the dopamine deficiency which characterises Parkinson’s disease by stimulating striatal dopamine receptors.

List of Excipients

Tablet core:

Ammonio Methacrylate Copolymer, Type B
Hypromellose
Sodium lauryl sulfate
Copovidone
Magnesium stearate

Tablet coat:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin
Iron oxide red (E172)

Pack sizes and marketing

ROPIQUAL XL is supplied in white opaque PVC/PCTFE-Aluminum foil blister packs of 28, 30, 42 and 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0236

30/07/2021

Drugs

Drug Countries
ROPIQUAL United Kingdom

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