Code | 3593D | ||||||||||
MA number | 73/0031/20-S | ||||||||||
Product Form: | sol inj 5x1 ml (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AS KALCEKS, Latvia | ||||||||||
Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Subcutaneous, intramuscular and intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 05.03.2020 |
Validity: | 05.03.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Scopolamine butylbromide Kalceks 20 mg_ml injekčný roztok_12_2022.pdf |
SPC: | SPC_Scopolamine butylbromide Kalceks 20 mg_ml injekčný roztok_12_2022.pdf |
Safety feature | Yes |
Data update: | 08.12.2020 |