Code | 2436D | ||||||||||
MA number | 77/0283/19-S | ||||||||||
Product Form: | cps dur 90x0,5 mg/0,4 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | ARDEZ Pharma, spol. s r.o., Czechia | ||||||||||
Therapeutic Class: | 77 - SYMPATHOLYTICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 25.09.2019 |
Validity: | 25.09.2024 |
MA renewed: | Renewal application submitted |
Pediatric contraindication: | Yes |
SPC: | SPC_Tedez_cps dur_01_2021.docx |
PIL: | PIL_Tedez_cps dur_01_2021.docx |
Safety feature | Yes |
Data update: | 22.10.2019 |