Language
Germany

Initial notification · 04.09.2026

Supply shortage Germany: Nilotinib Viatris 50 mg Hartkapseln

Affected country: Germany · Reported period: 19.12.2025 – 05.10.2026 · Active ingredient: Nilotinibhydrochlorid-Dihydrat

CountryGermany
PZN19368381
ENR7013504
Notification typeInitial notification
Start19.12.2025
Expected end05.10.2026
Last update04.09.2026
ReasonInsufficient manufacturing capacity
ATCL01EA03
Hospital-relevantNo

Notice context

A supply shortage has been recorded for Nilotinib Viatris 50 mg Hartkapseln in Germany. The stated reason is “Insufficient manufacturing capacity”. The notice concerns the active ingredient Nilotinibhydrochlorid-Dihydrat and is not identified as hospital-relevant.

This information describes the reported supply status and is not medical or pharmaceutical treatment advice. Availability, alternatives and further measures must be assessed for each individual case by the responsible pharmaceutical market participants.

Primary source: PharmNet.Bund / BfArM

Official shortage notice for Germany. Responsibility and update procedures follow the information supplied by the relevant authority.

Check the official notice list →

Implications for procurement and the supply chain

The notice for Nilotinib Viatris 50 mg Hartkapseln is a supply signal concerning Nilotinibhydrochlorid-Dihydrat in Germany. The published reason “Insufficient manufacturing capacity” determines which data should be verified first.

For manufacturing or capacity constraints, the focus is on credible restart dates, available batches, qualified sources and the coverage of existing stock.

Decision route for this supply case

  1. Confirm the notice, product identity, period and actual demand with the primary source and accountable market participants.
  2. Assess restart timing, available batches, qualified sources and a lawful bridging stock separately.
  3. Document release, stock status, GDP evidence, warehousing and transport process, and escalation responsibility.

Inter-Pharma can structure the B2B case, potential sourcing and warehousing routes, and operational implementation. Clinical decisions, regulatory permissibility, product release and actual availability remain with the accountable parties.

Request a structured supply review →

Operational shortage resilience: GDP warehousing and pharmaceutical storage

For manufacturing shortages, an agreed restart stock for Nilotinib Viatris 50 mg Hartkapseln can be received and distributed under control after release.

Inter-Pharma combines GDP-oriented pharmaceutical storage in Czechia with batch and expiry control, FEFO, stock status, picking and dispatch preparation in its own Cheb operation.

Storage at 15–25 °C or any 2–8 °C requirement is derived solely from the product specification and confirmed for the project.

Operational checks for this notice

  • Match product identity using PZN 19368381, active ingredient, strength, dosage form and pack.
  • Confirm the reported status and the period 19.12.2025 to 05.10.2026 with the primary source and potential suppliers.
  • Document demand, stock coverage, open orders and lawful alternative or sourcing routes for the specific case.
  • Clarify temperature, batch, expiry, stock status, recipient authorisation and GDP evidence before cross-border supply.

Relevant services and specialist pages

The following B2B topics are particularly relevant when handling a shortage involving Nilotinib Viatris 50 mg Hartkapseln:

Related topics