guanylate cyclase-C agonist
Is Linaclotide legal?
Answer
Linaclotide is authorised or registered in 5 of the 10 registers read: United States, European Union, United Kingdom, Canada, Switzerland.
Each row is what that country's own register said on the date shown. Not legal advice.
| Country | Status | Products on the register | Register | Read |
|---|---|---|---|---|
| United States | FDA-approved | Linzess | Regulator FDA | 2026-10-03 |
| European Union | Authorised | Constella | Regulator EMA | 2026-10-03 |
| United Kingdom | Authorised | Constella | Regulator MHRA | 2026-10-03 |
| Canada | Authorised | Constella | Regulator Health Canada | 2026-10-03 |
| Australia | Status unknown | - | TGA | Not read yet |
| Switzerland | Authorised | Axulta, Kapseln, Constella, Kapseln | Regulator Swissmedic | 2026-10-03 |
| Brazil | Not on the register | - | Regulator ANVISA | 2026-09-03 |
| Serbia | Not on the register | - | Regulator ALIMS | 2026-09-03 |
| Singapore | Not on the register | - | Regulator HSA | 2026-09-03 |
| Turkey | Not on the register | - | Regulator TITCK | 2026-09-03 |
A country not listed has no register read yet; see the world map. EU decisions also apply in Iceland, Liechtenstein and Norway.
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