RESOLOR Film-coated tablet Ref.[8877] Active ingredients: Prucalopride

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland

Product name and form

Resolor 1 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White to off-white, round, biconvex tablets marked “PRU 1” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 1 mg prucalopride (as succinate).

Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prucalopride

Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities. Prucalopride is a selective, high affinity serotonin (5-HT4) receptor agonist, which is likely to explain its prokinetic effects.
List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose
Colloidal silicon dioxide
Magnesium stearate

Tablet coating:

Hypromellose
Lactose monohydrate
Triacetin
Titanium dioxide (E171)
Macrogol

Pack sizes and marketing

Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets. Each pack contains 7 × 1, 14 × 1, 28 × 1 or 84 × 1 film-coated tablet.

Not all pack sizes may be marketed.

Marketing authorization holder

Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland

Marketing authorization dates and numbers

EU/1/09/581/001 (28 tablets)
EU/1/09/581/003 (7 tablets)
EU/1/09/581/005 (14 tablets)
EU/1/09/581/007 (84 tablets)

Date of first authorisation: 15 October 2009
Date of latest renewal: 06 June 2014

Drugs

Drug Countries
RESOLOR Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Singapore, United Kingdom
 
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