| Code | 5756E | ||||||||||
| MA number | 69/0052/24-S | ||||||||||
| Product Form: | pas ord 16x3 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Cassella-med GmbH & Co. KG, Germany | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 11.04.2024 |
| Validity: | 11.04.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Orocalm med a pomaranč 3 mg tvrdé pastilky_12/2024.pdf
|
| PIL: |
PIL_Orocalm med a pomaranč 3 mg tvrdé pastilky_12/2024.pdf
|
| Safety feature | No |
| Data update: | 16.04.2024 |
