MOVENTIG Film-coated tablet Ref.[9195] Active ingredients: Naloxegol

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands

Product name and form

Moventig 12.5 mg film-coated tablets.

Moventig 25 mg film-coated tablets.

Pharmaceutical Form

Moventig 12.5 mg film-coated tablet (tablet): Oval, 10.5x5.5 mm, mauve tablet.

Moventig 25 mg film-coated tablet (tablet): Oval, 13x7 mm, mauve tablet.

Tablets are engraved with “nGL” on one side and the strength of the tablet on the other.

Qualitative and quantitative composition

Moventig 12.5 mg film-coated tablets: Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.

Moventig 25 mg film-coated tablets: Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Naloxegol

Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone. PEGylation reduces naloxegol’s passive permeability and also renders the compound a substrate for the P-glycoprotein transporter. Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system.

List of Excipients

Tablet core:

Mannitol (E421)
Cellulose microcrystalline (E460)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)
Propyl gallate (E310)

Tablet coat:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

Alu/alu blister.

12.5 mg film-coated tablets: Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters. Pack sizes of 30 × 1 and 90 × 1 film-coated tablets in perforated unit dose blisters.

25 mg film-coated tablets: Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters. Pack sizes of 10 × 1, 30 × 1, 90 × 1 and 100 × 1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands

Marketing authorization dates and numbers

EU/1/14/962/001
EU/1/14/962/002
EU/1/14/962/003
EU/1/14/962/004
EU/1/14/962/005
EU/1/14/962/006
EU/1/14/962/007
EU/1/14/962/008
EU/1/14/962/009
EU/1/14/962/010
EU/1/14/962/011

Date of first authorisation: 8 December 2014
Date of latest renewal: 23 September 2019

Drugs

Drug Countries
MOVENTIG Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

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