Carmustine 100 mg powder and solvent for concentrate for solution for infusion: Change history
View Patient Information Leaflet (Carmustine 100 mg powder and solvent for concentrate for solution for infusion)
Last updated on this site: 18 Dec 2025
Type IA (A.7) variation application to delete Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht Netherlands as a site responsible for batch release of the finished product.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., 1045 Budapest, Anonymus ut 6. Hungary to Eurofins BioPharma Product Testing Budapest Kft., 1045 Budapest, Anonymus ut 6. Hungary. The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Lab Analysis S.r.l. Via Europa 5, Casanova Lonati (Pavia) 27041, Italy to Labanalysis Life Science S.r.l., Via Europa 5, Casanova Lonati (Pavia) 27041, Italy . The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Pharmavalid Ltd.,Microbiological Laboratory Tátra u. 27/b.,1136,Budapest, Hungary to Pharmavalid Kft., Tátra u. 27/b., 1136, Budapest, Hungary. The address remains unchanged.
Last updated on this site: 18 Dec 2025
Type IA (A.7) variation application to delete Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht Netherlands as a site responsible for batch release of the finished product.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., 1045 Budapest, Anonymus ut 6. Hungary to Eurofins BioPharma Product Testing Budapest Kft., 1045 Budapest, Anonymus ut 6. Hungary. The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Lab Analysis S.r.l. Via Europa 5, Casanova Lonati (Pavia) 27041, Italy to Labanalysis Life Science S.r.l., Via Europa 5, Casanova Lonati (Pavia) 27041, Italy . The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Pharmavalid Ltd.,Microbiological Laboratory Tátra u. 27/b.,1136,Budapest, Hungary to Pharmavalid Kft., Tátra u. 27/b., 1136, Budapest, Hungary. The address remains unchanged.
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Changes: (Updated: 18 Dec 2025)
Type IA (A.7) variation application to delete Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht Netherlands as a site responsible for batch release of the finished product.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., 1045 Budapest, Anonymus ut 6. Hungary to Eurofins BioPharma Product Testing Budapest Kft., 1045 Budapest, Anonymus ut 6. Hungary. The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Lab Analysis S.r.l. Via Europa 5, Casanova Lonati (Pavia) 27041, Italy to Labanalysis Life Science S.r.l., Via Europa 5, Casanova Lonati (Pavia) 27041, Italy . The address remains unchanged.
Type IA (A.5.b) variation to change the name of the site responsible for batch control/testing of the finished product from Pharmavalid Ltd.,Microbiological Laboratory Tátra u. 27/b.,1136,Budapest, Hungary to Pharmavalid Kft., Tátra u. 27/b., 1136, Budapest, Hungary. The address remains unchanged.
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Changes: (Updated: 13 Oct 2025)
New product launch.