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PRODUCT DETAIL

PEDIPPI 2 mg/ml prášok na perorálnu suspenziu

Code 7060E
MA number 09/0047/24-S
Product Form: plu por 1x47 g (fľ.PET + striek.dávk.per.PP)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Xeolas Pharmaceuticals Limited, Ireland
Therapeutic Class: 09 - ANTACIDA (VRÁTANE ANTIULCEROSNYCH LIEČIV)
ATC:
A ALIMENTARY TRACT AND METABOLISM
A02 DRUGS FOR ACID RELATED DISORDERS
A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX
A02BC Proton pump inhibitors
A02BC01 Omeprazole
Shelf life: 24
Container: bottle polyethylene terephtalate (PET)
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 03.10.2024
Validity: 03.10.2029
MA renewed: Renewal application submitted
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_PEDIPPI 2 mg_ml prášok na perorálnu suspenziu_09_2024.pdf  
SPC: SPC_PEDIPPI 2 mg_ml prášok na perorálnu suspenziu_09_2024.pdf  
Safety feature Yes
Data update: 25.10.2024
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