Code | 3353E | ||||||||||
MA number | 87/0089/23-S | ||||||||||
Product Form: | cps dur 100x167 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | TILLOMED PHARMA GmbH, Germany | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 28.04.2023 |
Validity: | 28.04.2028 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Trientine Tillomed 167 mg tvrdé kapsuly_06.2023.pdf |
PIL: | PIL_Trientine Tillomed 167 mg tvrdé kapsuly_08.2023.pdf |
Safety feature | Yes |
Data update: | 28.04.2023 |