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Community Register of medicinal products
Community register of orphan medicinal products | GRANTED |
Product information |
Metronidazole
| EU orphan designation number: | EU/3/11/875
|
| Active ingredient: | Metronidazole |
| Indication: | Treatment of pouchitis |
| Sponsor: | FORMAC Pharmaceuticals NV
Gaston Geenslaan 1, B-3001 Leuven, België |
Public summary of scientific opinion
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 24/06/2011 | Centralised Orphan - Designation | EMA/OD/167/10 | (2011)4549 of 21/06/2011 |