Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands
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. |
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) Tablet coat: Hypromellose (E464) |
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.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands
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
| Drug | Countries | |
|---|---|---|
| MOVENTIG | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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