| Code | 1548E | ||||||||||
| MA number | 61/0198/22-S | ||||||||||
| Product Form: | sol rec 1x133 ml (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Casen Recordati, S.L., Spain | ||||||||||
| Therapeutic Class: | 61 - LAXANTIA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Rectal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Cleenema 180,8 mg_ml + 79,9 mg_ml rektálny roztok_10_2022.pdf
|
| SPC: |
SPC_Cleenema 180,8 mg_ml + 79,9 mg_ml rektálny roztok_10_2022.pdf
|
| Safety feature | No |
| Data update: | 21.01.2023 |
