PIL - Midazolam 1mg/ml, 5mg/ml solution for injection or infusion: Change history
View Patient Information Leaflet (PIL - Midazolam 1mg/ml, 5mg/ml solution for injection or infusion)
Last updated on this site: 03 Oct 2024
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 00 to R1-CEP 2010-141-Rev 01.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 01 to R1-CEP 2010-141-Rev 02.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP 2002-059-Rev 03 to R1-CEP 2002-059-Rev 04.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP2002-059-Rev 04 to R1-CEP 2002-059-Rev 05.
A.7. Deletion batch release site Accord Healthcare B.V., Netherlands
Last updated on this site: 03 Oct 2024
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 00 to R1-CEP 2010-141-Rev 01.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 01 to R1-CEP 2010-141-Rev 02.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP 2002-059-Rev 03 to R1-CEP 2002-059-Rev 04.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP2002-059-Rev 04 to R1-CEP 2002-059-Rev 05.
A.7. Deletion batch release site Accord Healthcare B.V., Netherlands
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Changes: (Updated: 03 Oct 2024)
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 00 to R1-CEP 2010-141-Rev 01.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. RA Chem Pharma Limited; CEP update from R1-CEP 2010-141-Rev 01 to R1-CEP 2010-141-Rev 02.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP 2002-059-Rev 03 to R1-CEP 2002-059-Rev 04.
- update European Pharmacopoeial Certificate of Suitability from already approved manufacturer i.e. Sun Pharmaceuticals Industries Limited; CEP update from R1-CEP2002-059-Rev 04 to R1-CEP 2002-059-Rev 05.
A.7. Deletion batch release site Accord Healthcare B.V., Netherlands
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Changes: (Updated: 14 Aug 2024)
To update SmPC sections 4.2, 4.4, 4.5, 5.1 and leaflet sections 2, 3, 4 in line with the reference product (Hypnovel 10 mg/2 ml Solution for Injection; MA number: PA2239/007/001; MAH: Cheplapharm Arzneimittel GmbH, Germany).
Additionally, editorial updates have been made to the PIL.
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Changes: (Updated: 30 Aug 2023)
To update SmPC section 4.8 and leaflet section 4 to implement the wording agreed by the PRAC following the outcome of the PSUSA procedure (PSUSA/00002057/202209).
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Changes: (Updated: 21 Sep 2022)
Initial upload