61 Authorisations granted for 2 substances
On 5-15 June 2023, the European Commission granted 61 Authorisations for the following substances:
The Authorisations are held by 15 companies and concern 20 Authorised uses:
Authorisation numbers REACH/23/15/0, REACH/23/15/1, REACH/23/15/2, REACH/23/15/3, REACH/23/15/4, REACH/23/15/5, REACH/23/15/6, REACH/23/15/7, REACH/23/15/8, REACH/23/15/9, REACH/23/15/10, REACH/23/15/11, REACH/23/15/12, REACH/23/15/13, REACH/23/15/14, REACH/23/15/15, REACH/23/15/16, REACH/23/15/17, REACH/23/15/18, REACH/23/15/19, REACH/23/15/20, REACH/23/15/21REACH/23/15/22, REACH/23/15/23, REACH/23/15/24, REACH/23/15/25, REACH/23/15/26, REACH/23/15/27, REACH/23/15/28, REACH/23/15/29, REACH/23/15/30, REACH/23/15/31, REACH/23/15/32, REACH/23/15/33, REACH/23/15/34, REACH/23/15/35, REACH/23/15/36, REACH/23/15/37, REACH/23/15/38, REACH/23/15/39, REACH/23/15/40, REACH/23/15/41, and REACH/23/15/42 are held by Beckman Coulter Ireland Inc, Immunotech S.R.O., Immunotech S.A.S, Beckman Coulter France S.A.S, Beckman Coulter Ceská republika s.r.o., Beckman Coulter, S.L.U., Beckman Coulter SPA Italy, BC Distribution B.V., and Beckman Coulter GmbH, and approve the formulation of 4-tertOPnEO solutions in European sites for use as laboratory products; the in-process production use of 4-tert-OPnEO as a washing buffer used in the creation of in vitro diagnostic immunoassay particles; the downstream use of 4-tert-OPnEO containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays; the downstream use of 4-tert-OPnEO containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development; the phase out of 4-tert-OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations; the formulation of 4-NPnEO solutions in European sites for use as laboratory products; the downstream use of 4-NPnEO containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays; and the downstream use of 4-NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development.
Authorisation numbers REACH/23/17/0, REACH/23/17/1, REACH/23/17/2, REACH/23/17/3, REACH/23/17/4, REACH/23/17/5, REACH/23/17/6, REACH/23/17/7, REACH/23/17/8, REACH/23/17/9, REACH/23/17/10, REACH/23/17/11, REACH/23/17/12, and REACH/23/17/13 are held by QIAGEN GmbH, STAT-Dx Life S.L., and QIAGEN Distribution B.V, and approve the formulation and filling of buffer solutions containing 4-tert-OPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing; the formulation and filling of buffer solutions containing 4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing; the industrial use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing; the industrial use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing; the professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing and immunoassay; the professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing; the professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing; and the professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing
Authorisation number REACH/23/18/0 is held by Alexion Pharma International Operations Unlimited Company, and approves the industrial use of 4-tert-OPnEO for virus inactivation in the manufacture of Andexanet alfa for treatment of adult patients treated with a direct factor Xa (FXa) inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Authorisation number REACH/23/20/0 is held by Merck Millipore Limited, and approves the industrial use of 4-tert-OPnEO as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes).
Authorisation number REACH/23/20/1 is held by Merck Millipore Limited, and approves the downstream use of 4-tert-OPnEO as a component of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes).
Authorisation number REACH/23/19/0 is held by LFB Biomedicaments, and approves the use of 4-tert-OPnEO for virus inactivation into the manufacture process of plasma-derived immunoglobulins.