US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PIASKY | 340MG/2ML(170MG/ML) | injectable · intravenous | GENENTECH INC | Prescription | 20 Jun 2024 |
EMA European Union — centrally authorised medicines
Piasky Roche Registration GmbH · Authorised · authorised 22 Aug 2024 · ATC L04AJ07
Therapeutic indication (EMA)
Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| PIASKY | 02558262 | 170 MG / ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.