availability status of several specialties

Between July 24 and August 6, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) reported new disruptions or updated the availability data for several specialties marketed in France. [1]distributed exclusively to the hospital.

ETOPOSIDE ACCORD and TEVA: out of stock of several presentations

ETOPOSIDE ACCORD 20 mg/mL solution for dilution for infusion in 25 mL and 50 mL vials (etoposide)

ETOPOSIDE TEVA 20 mg/mL solution for dilution for infusion in vials of 5 mL, 10 mL, 25 mL and 50 mL (etoposide)

Availability status according to ANSM

ETOPOSIDE ACCORD 20 mg/mL solution for dilution for infusion in 25 mL and 50 mL vials

ETOPOSIDE TEVA 20 mg/mL solution for dilution for infusion in vials of 5 mL, 10 mL, 25 mL and 50 mL

Additional information from the laboratory

Newsletter from the Accord Healthcare France laboratory for healthcare professionals from July 1, 2024 (July 10, 2024)

FLUOROURACILE ACCORD: 5 mL and 100 mL vials out of stock

FLUOROURACILE ACCORD 50 mg/mL solution for dilution for infusion (fluorouracil)

Availability status according to ANSM

HUMAN IMMUNOGLOBULINS: persistent supply problems

Human Normal Immunoglobulin IV and SC Specialties

Availability status according to ANSM

• Immunoglobuline IV (cf. our article of March 14, 2024)
  • Supply voltage
  • From January 2024, contingent distribution up to usual needs (base before September 2023)
  • The specialties of the Grifols laboratory can compensate for the increase in additional needs observed since September 2023 up to the amount of the anticipated missing quantity
  • Indefinite availability

• Immunoglobuline SC :
  • Supply voltage
  • From January 2024, contingent distribution up to usual needs (September 2023 base)
  • The specialties of the Grifols laboratory can compensate for part of the increase in additional needs observed since September 2023 up to the amount of the anticipated missing quantity
  • Xembify (IgSC) may also be used exceptionally in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
  • Indefinite availability

Additional information from the laboratory

Letter from the Takeda laboratory dated July 23, 2024 to the attention of healthcare professionals (on the ANSM website on July 30, 2024): supply difficulties for human normal immunoglobulins SC until the first quarter of 2025.

METHOTREXATE ACCORD 100 mg/mL : rupture de stock

METHOTREXATE ACCORD 100 mg/mL concentrate for solution for infusion – 10 mL and 50 mL vial (methotrexate)

Availability status according to ANSM

• Out of stock of 10 mL and 50 mL vial presentations (cf. our article of July 2, 2024)
• Exceptional and temporary provision to internal use pharmacies (PUI) of specialty units Methotrexate Ebewe 100MG/ML Concentrate for solution for infusion (5000 mg/50 mL vial), initially intended for the Slovenian market since June 3, 2024
• Please note: The expiration date of imported units is August 31, 2024.
• Exceptional and temporary provision to the PUI of specialty units Methotrexate 100 mg/ml solution for injection (5000 mg/50 ml vial), initially intended for the English market since June 28, 2024
• Normal undetermined re-availability of the 10 mL bottle presentation and from the end of August 2024 for the 50 mL bottle presentation (instead of the end of July 2024: cf. our article of July 2, 2024)

Additional information from the laboratory

Accord Healthcare France Laboratory Newsletter from June 12, 2024 to the attention of healthcare professionals (July 1, 2024)

NOVOEIGHT 2000 UI : en tension

NOVOEIGHT 2000 IU powder and solvent for solution for injection (turoctocog alfa)

Availability status according to ANSM

• Situation at the hospital: tension
• In-store pharmacies (PUIs) are invited to reserve remaining available stocks of NovoEight 2000 IU for patients on retrocession
• Stocks of other dosages (500, 1000 and 3000 IU) are sufficient to cover the tension in 2000 IU
• Expected delivery date September 2024

UN-ALFA specialties: between tension and stock shortages

Un-Alfa 2 µg/1 mL, solution injectable IV en ampoule (alfacalcidol)

Un-Alfa 1 µg/0,5 ml, solution injectable IV en ampoule

Availability status according to ANSM

Un-Alpha 2 µg/1 mL

• Rupture de stock
• Indefinite availability
• Importation of 1,326 boxes of 10 ampoules of 1 ml of One-Alpha 2MCG/ML 1ML AMP 10 initially intended for Canada

Un-Alpha 1 µg/0.5 ml

• Supply voltage
• Indefinite availability
• Import of Etalpha 2MCG/ML 0.5ML AMP 10 initially intended for Denmark, the Netherlands and Spain

Additional information from the laboratory

Un-Alpha 2 µg/1 mL

• Two letters from the Cheplapharm laboratory intended for hospital pharmacists concerning:

Un-Alpha 1 µg/0.5 ml

• Three letters from the Cheplapharm laboratory concerning the provision of equivalent specialties initially intended for:

Discounts available

The ANSM has confirmed the normal resumption of availability of the following hospital specialties: