Code | 3461D | ||||||||
MA number | 73/0012/20-S | ||||||||
Product Form: | cps enm 14x90 mg/50 mg (blis.PVC/PVDC/Al) | ||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||
Type of procedure: | Decentralised | ||||||||
Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||
ATC: |
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Shelf life: | 48 | ||||||||
Container: | blister PVC/PVDC/Al | ||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 12.02.2020 |
Validity: | 12.02.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Gaspan_cps enm_05_2020.docx |
PIL: | PIL_Gaspan_cps enm_05_2020.docx |
Safety feature | No |
Data update: | 12.05.2020 |