Medicines authorised in Romania

Pradaxa

Pradaxa is a medicine containing Dabigatranum Etexilatum, listed in the Romanian national register of medicines for human use with 20 presentations.

General information from the official register, not medical advice. Anpheros does not diagnose and does not recommend medicines. Read the package leaflet and ask your doctor or pharmacist before taking any medicine.

At a glance

Active substance
DABIGATRANUM ETEXILATUM · all medicines with Dabigatranum Etexilatum
ATC code
B01AE07 Blood and blood forming organs
Therapeutic action
ANTITROMBOTICE INHIBITORI DIRECTI AI TROMBINEI
Prescription
Prescription required (register code PRF)
Prescription required (register code P-RF)
Marketing authorisation holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH - GERMANIA
Manufacturer
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - GERMANIA
Pharmaceutical form
GRANULE DRAJEFIATE
CAPS.

Presentations and codes

CIM is the code of each pack in the Romanian register; the Anpheros app saves it when it recognises the box.

CIM codeFormStrengthPackPrescriptionAuthorisationShelf life
W52942001CAPS.75mgCutie x 1 blist. (Al/Al) x 10 caps. (10x1 blister perforat unidoza )P-RF442/2008/012 ani
W52942002CAPS.75mgCutie x 3 blist. (Al/Al) x 10 caps. (30x1 blister perforat unidoza )P-RF442/2008/022 ani
W52942003CAPS.75mgCutie x 6 blist. (Al/Al) x 10 caps. (60 x1 blister perforat unidoza )P-RF442/2008/032 ani
W52942004CAPS.75mgCutie x 1 flac. PP x 60 caps.P-RF442/2008/042 ani
W52943001CAPS.110mgCutie x 1 blist. (Al/Al) x 10 caps. (10x1 blister perforat unidoza )P-RF442/2008/052 ani
W52943002CAPS.110mgCutie x 3 blist. (Al/Al) x 10 caps. (30x1 blister perforat unidoza )P-RF442/2008/062 ani
W52943003CAPS.110mgCutie x 6 blist. (Al/Al) x 10 caps. (60x1 blister perforat unidoza )P-RF442/2008/072 ani
W52943004CAPS.110mgCutie x 1 flac PP x 60 caps.P-RF442/2008/082 ani
W52943005CAPS.110mgAmbalaj multiplu cu 3 cutii a câte 60 x 1 capsule (180 capsule) în blist.din Al perforate- unidozaP-RF442/2008/142 ani
W57151001CAPS.150mgCutie x 1 blist. (Al/Al) x 10 caps. (10x1 blister perforat unidoza )P-RF442/2008/092 ani
W57151002CAPS.150mgCutie x 3 blist. (Al/Al) x 10 caps. (30x1 blister perforat unidoza )P-RF442/2008/102 ani
W57151003CAPS.150mgCutie x 6 blist. (Al/Al) x 10 caps. (60 x1 blister perforat unidoza )P-RF442/2008/112 ani
W57151004CAPS.150mgAmbalaj multiplu cu 3 cutii a câte 60 x 1 capsule (180 capsule) în blist.din Al perforate- unidozaP-RF442/2008/122 ani
W57151005CAPS.150mgCutie x 1 flac. PP x 60 caps.P-RF442/2008/132 ani
W69037001GRANULE DRAJEFIATE20mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/253 ani
W69038001GRANULE DRAJEFIATE30mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/263 ani
W69039001GRANULE DRAJEFIATE40mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/273 ani
W69040001GRANULE DRAJEFIATE50mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/283 ani
W69041001GRANULE DRAJEFIATE110mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/293 ani
W69042001GRANULE DRAJEFIATE150mgCutie cu 60 plicuri din PET/Al/LDPEPRF442/2008/303 ani

What it is used for

Anpheros does not have a page with official indications for this substance yet.

The package leaflet and the summary of product characteristics are published by ANMDMR: search for “Pradaxa” in the national register.

Other medicines with Dabigatranum Etexilatum

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Source: ANMDMR — National Agency for Medicines and Medical Devices of Romania, Nomenclatorul medicamentelor de uz uman (register updated 29 October 2026). Shown as published, in Romanian where the register is in Romanian.