Code | 4179A | ||||||||||
MA number | EU/1/11/690/004 | ||||||||||
Product Form: | tbl flm 364 (312 akt.+52 placebo)x2,5 mg/1,5 mg (blis.PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Theramex Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 17 - ANTICONCIPIENTIA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10b fixed combination application |
MA issued: | 29.10.2012 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Kombinovaná hormonálna antikoncepcia Informačná karta pre pacientku.pdf |
Dokument: | Kombinovaná hormonálna antikoncepcia Kontrolný zoznam pre lekára.pdf |
Dokument: | Kombinovaná hormonálna antikoncepcia Otázky a odpovede pre pacientky.pdf |
Safety feature | Yes |
Data update: | 24.05.2021 |