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IT ATC B01AE07 · updated 2 Nov 2026

Dabigatran Etexilate shortage in Italy

Is there a Dabigatran Etexilate shortage in Italy?

Yes. As of 2 Nov 2026, 9 Dabigatran Etexilate products are reported short in Italy, the first since 2 Jan 2026. The company estimate for the return is 31 Dec 2026 (latest 28 Feb 2027). Main reason: manufacturing problem.

Also short in Canada, Germany, Spain, Austria, Belgium, Czechia, Norway, Sweden, Australia. All countries.

Affected products in Italy

CountryProductCompanySinceExpected backReason
ITDABIGATRAN ETEXILATO MEDICAL VALLEYMEDICAL VALLEY INVEST AB2 Jan 202631 Dec 2026Increased demand
Elevata richiesta/problemi produttivi (carenza relativa solo al canale ospedaliero)
ITDABIGATRAN ETEXILATO MEDICAL VALLEYMEDICAL VALLEY INVEST AB1 May 202631 Dec 2026Increased demand
Elevata richiesta/problemi produttivi (carenza relativa solo al canale ospedaliero)
ITDABIGATRAN ETEXILATO VIATRISMYLAN S.P.A.15 May 2026not givenManufacturing problem
Problemi produttivi
ITDABIGATRAN ETEXILATO ACCORDACCORD HEALTHCARE, S.L.U.22 Jul 2026not givenIncreased demand
Elevata richiesta
ITDABIGATRAN ETEXILATO VIATRISMYLAN S.P.A.10 Sep 2026not givenManufacturing problem
Problemi produttivi
ITDABIGATRAN ETEXILATO VIATRIS anticipatedMYLAN S.P.A.20 Nov 2026not givenManufacturing problem
Problemi produttivi
ITDABIGATRAN ETEXILATO TEVA anticipatedTEVA GMBH7 Dec 2026not givenCommercial decision or withdrawal
Motivi commerciali
ITDABIGATRAN ETEXILATO TEVA anticipatedTEVA GMBH7 Dec 2026not givenCommercial decision or withdrawal
Motivi commerciali
ITDABIGATRAN ETEXILATO TEVA anticipatedTEVA GMBH7 Dec 202628 Feb 2027Manufacturing problem
Problemi produttivi

Source

AIFA (Italian Medicines Agency), licensed CC-BY 4.0. Official list. All shortages reported by marketing-authorisation holders, including medicines being withdrawn.