Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merz Therapeutics GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Germany
Inbrija 33 mg inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule. White opaque capsules containing white powder, with "A42" printed in black on the cap of the capsule and two black bands printed on the body of the capsule. |
Each hard capsule contains 42 mg levodopa.
Each delivered dose contains 33 mg levodopa.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease. |
| List of Excipients |
|---|
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Capsule content: Colfosceril palmitate (DPPC) Capsule shell: Hypromellose Ink: Shellac |
The hard capsules are supplied in Aluminium/PVC/Aluminium peel-off blisters. Each perforated unit-dose blister strip contains 4 hard capsules.
The Inbrija inhaler is made of polybutylene terephthalate (PBT), polycarbonate (PC) and polypropylene (PP). Puncturing tines and springs are made from stainless steel.
Carton containing 16 hard capsules (4 blister strips) and one inhaler.
Carton containing 32 hard capsules (8 blister strips) and one inhaler.
Carton containing 60 hard capsules (15 blister strips) and one inhaler.
Carton containing 92 hard capsules (23 blister strips) and one inhaler.
Not all pack sizes may be marketed.
Merz Therapeutics GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Germany
EU/1/19/1390/001
EU/1/19/1390/002
EU/1/19/1390/003
EU/1/19/1390/004
Date of first authorisation: 19 September 2019
Date of latest renewal: 13 June 2024
| Drug | Countries | |
|---|---|---|
| INBRIJA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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