Actions on CEPs
CEP Suspensions
Upon request from the holder, due to a temporary inability to produce under the approved conditions
Date |
Substance name |
CEP Number |
---|---|---|
- |
- | - |
Due to GMP non-compliance
Date |
Substance name |
CEP Number |
---|---|---|
03/04/2024 | Esomeprazole Magnesium trihydrate | CEP 2014-147 |
03/04/2024 | Omeprazole | CEP 2014-035 |
Due to a failure to fulfil the requirements of the Certification procedure
Date |
Substance name |
CEP Number |
---|---|---|
- |
- | - |
CEP Withdrawals
Due to GMP non-compliance
Date |
Substance name |
CEP Number |
---|---|---|
03/01/2024 | Paracetamol | CEP 2007-054 |
Due to a failure to fulfill the requirements of the Certification Procedure
Date |
Substance name |
CEP Number |
---|---|---|
09/11/2023 | Oxytetracycline hydrochloride | CEP 2013-200 |
09/11/2023 | Oxytetracycline dihydrate, process B | CEP 2013-196 |
09/11/2023 | Oxytetracycline dihydrate | CEP 2011-079 |
22/09//2023 | Ramipril | CEP 2006-006 |
22/09//2023 | Cefixime | CEP 2008-124 |
22/09//2023 | Lamotrigine | CEP 2009-278 |
Due to the deletion of the monograph from the European Pharmacopoeia
Date |
Substance name |
CEP Number |
---|---|---|
- | - | - |
Restoration of suspended CEP
Date |
Substance name |
CEP Number |
---|---|---|
02/02/2024 | Tropicamide | CEP 1998-077 |
19/01/2024 | Cefotaxime sodium, sterile | CEP 2014-197 |
19/01/2024 | Amoxicillin sodium, sterile | CEP 1996-013 |
19/01/2024 | Piperacillin sodium, sterile | CEP 2006-252 |
19/01/2024 | Piperacillin sodium, sterile | CEP 1999-117 |
17/01/2024 | Cefuroxime sodium, sterile | CEP 2014-021 |
17/01/2024 | Flucloxacillin sodium monohydrate, sterile | CEP 1999-039 |
31/08/2023 | Ranitidine Hydrochloride | CEP 2017-068 |
Looking for a CEP?
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).