Code | 2565A | ||||||||||
MA number | 65/0411/12-S | ||||||||||
Product Form: | sol por 1x100 ml/0,4g (fľ.HDPE+striek.inj.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Grünenthal GmbH, Germany | ||||||||||
Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 12.09.2012 |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 13.04.2018 |