Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, The Netherlands
Rizmoic 200 micrograms film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Round, approximately 6.5 mm diameter, yellow tablet debossed with ‘222’ and Shionogi logo on one side and ‘0.2’ on the other side. |
Each tablet contains 200 micrograms naldemedine (as tosylate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Naldemedine |
Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system (CNS)-mediated opioid effects. |
| List of Excipients |
|---|
|
Tablet core: Mannitol Film coating: Hypromellose |
Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, The Netherlands
EU/1/18/1291/001
EU/1/18/1291/002
EU/1/18/1291/003
EU/1/18/1291/004
EU/1/18/1291/005
EU/1/18/1291/006
Date of first authorisation: 18 February 2019
| Drug | Countries | |
|---|---|---|
| RIZMOIC | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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