| Code | 33200 | ||||||||||
| MA number | 14/0289/01-S | ||||||||||
| Product Form: | tbl flm 20x25 mg | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 08.11.2001 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Prothazin_transfer_06.2016.docx
|
| PIL: |
PIL_Prothazin_04.2018.doc
|
| Safety feature | Yes |
| Data update: | 09.04.2018 |
