US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| INBRIJA | 42MG | powder · inhalation | MERZ | Prescription | 21 Dec 2018 |
| LARODOPA | 250MG; 100MG; 500MG | capsule · oral | ROCHE | Discontinued | 4 Jun 1970 |
| LARODOPA | 250MG; 500MG; 100MG | tablet · oral | ROCHE | Discontinued | 4 Jun 1970 |
| DOPAR | 250MG; 500MG; 100MG | capsule · oral | SHIRE | Discontinued | 4 Jun 1970 |
| DOPAR | 250MG; 500MG | tablet · oral | SHIRE | Discontinued | 4 Jun 1970 |
| BENDOPA | 250MG; 500MG; 100MG | capsule · oral | VALEANT PHARM INTL | Discontinued | |
EMA European Union — centrally authorised medicines
Inbrija Merz Therapeutics GmbH · Authorised · authorised 19 Sep 2019 · ATC N04BA01
Therapeutic indication (EMA)
Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Safety signals and safety-related labeling changes
- US FDA 7 Jul 2026 INBRIJA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 May 2026 CREXONT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 DHIVY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 DUOPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 RYTARY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 SINEMET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 SINEMET CR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 100 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 125 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 150 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 200 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 50 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Mar 2026 STALEVO 75 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for levodopa →
Combinations containing Levodopa
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.