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PRODUCT DETAIL

Remodulin 1 mg/ ml

Code 93637
MA number 16/0315/05-S
Product Form: sol inf 1x20 ml/20 mg (liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AC Platelet aggregation inhibitors excl. heparin
B01AC21 Treprostinil
Shelf life: 36
Container: glass vial
Route of admin.: Subcutaneous and intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 13.12.2005
Pediatric warnings: Yes
SPC: SPC_Remodulin_1 mgml_10.2021.pdf  
PIL: PIL_Remodulin_1 2,5 5 10 mgml_02.2022.pdf  
Safety feature Yes
Data update: 20.02.2018
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