Code | 46788 | ||||||||||
MA number | 87/0468/07-S | ||||||||||
Product Form: | cps mol 28x2 µg (blis.PVC/fluóropolymér/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | AbbVie s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 27.11.2007 |
Pediatric warnings: | Yes |
PIL: | PIL_Zemplar mikrogram mäkké kapsuly_01.2023.pdf |
SPC: | SPC_Zemplar mikrogram mäkké kapsuly_01.2023.pdf |
Safety feature | Yes |
Data update: | 08.04.2019 |