Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 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.
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
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.