Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: bene-Arzneimittel GmbH, Herterichstrasse 1-3, D-81479 Munich, tel: ++49 (0) 89/7 49 87-0, fax: ++49 (0) 89/7 49 87-142, e-mail: contact@bene-arzneimittel.de
elmiron 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. White opaque capsules size 2. |
Each hard capsule contains 100 mg of pentosan polysulfate sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pentosan polysulfate |
The hypothetic mechanism of action of pentosan polysulfate includes a local effect in the bladder after systemic administration and excretion into the urine by binding of glycosaminoglycans to the deficient mucous of the bladder. It is hypothesized, that a potential barrier function of pentosan polysulfate instead of the damaged urothelial mucus might play a role as well the antiinflammatory activity of pentosan polysulfate sodium. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Gelatin |
HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
PVC/Aclar-Aluminium blister with 90 (9x10) capsules.
Bottle:
Pack size of 90 capsules.
Pack size of 300 (3 bottles x 100) capsules.
Blister:
Pack size of 90 capsules.
Not all pack sizes may be marketed.
bene-Arzneimittel GmbH, Herterichstrasse 1-3, D-81479 Munich, tel: ++49 (0) 89/7 49 87-0, fax: ++49 (0) 89/7 49 87-142, e-mail: contact@bene-arzneimittel.de
EU/1/17/1189/001
EU/1/17/1189/002
EU/1/17/1189/003
Date of first authorisation: 2 June 2017
| Drug | Countries | |
|---|---|---|
| ELMIRON | Austria, Canada, Estonia, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
