European Medicines Agency Press Releases

• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Filsuvez, birch bark, decision type: PM: decision on the application ...

  P/0243/2023 : EMA decision of 16 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for birch bark extract (Filsuvez), (EMEA-001299-PIP03-17-M02) Reference Number: EMA/273941/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-001627-PIP01-14-M03

  P/0203/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M03) Reference Number: EMA/241957/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, decision ...

  P/0242/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M05) Reference Number: EMA/250921/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application ...

  P/0237/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M06) Reference Number: EMA/236245/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Adtralza, Tralokinumab, decision type: PM: decision on the application ...

  P/0186/2023 : EMA decision of 5 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (Adtralza), (EMEA-001900-PIP02-17-M07) Reference Number: EMA/175833/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-002229-PIP02-21-M01

  P/0217/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinylestradiol (EMEA-002229-PIP02-21-M01) Reference Number: EMA/238158/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Ontozry, cenobamate, decision type: PM: decision on the application for ...

  P/0214/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M02) Reference Number: EMA/256562/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-002735-PIP01-19-M01

  Deferoxamine (mesylate) histidine tryptophan aspartic acid n-acetyl-histidine (monohydrate) glycine alpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium chloride alanine 3,4-dimethoxy-N- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-002735-PIP03-20-M02

  histidine tryptophan aspartic acid n-acetyl-histidine (monohydrate) glycine alpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium chloride alanine 3,4-dimethoxy-N-methylbenzohydroxamic acid …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-002762-PIP02-20-M01

  P/0215/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for denecimig (EMEA- 002762-PIP02-20-M01) Reference Number: EMA/236605/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab, decision type: PM: decision on the application for ...

  P/0235/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sotrovimab (Xevudy), (EMEA-002899-PIP01-20-M02) Reference Number: EMA/236247/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab, decision type: PM: decision on the application ...

  P/0238/2023 : EMA decision of 14 June 2023on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M02) Reference Number: EMA/236249/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in ...

  P/0201/2023 : EMA decision of 13 June 2023 on the granting of a product specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP10-23) Reference Number: EMA/241874/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  Fifth EMA/HMA Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 28 ...

  In person and online participation via Webex is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate. The event will also be broadcast live and registration is not required to follow the event online.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 16:47 GMT

  EMEA-002052-PIP02-23

  P/0205/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for deutetrabenazine (EMEA-002052-PIP02-23) Reference Number: EMA/253093/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 11:15 GMT

  Human medicines European public assessment report (EPAR): Baraclude, entecavir, Date of authorisation: 26/06/2006, Revision: 28, ...

  Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B. Baraclude is taken once a day. For adults with compensated liver disease, the dose depends on whether or not the patient has been previously …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 5, 2024 - 11:15 GMT

  Pharmacovigilance fees payable to the European Medicines Agency

  The basis of calculation of pharmacovigilance fees for PSURs, pharmacovigilance referrals and the annual fee is the chargeable unit. This is defined in Article 2 of Regulation (EC) 658/2014. The chargeable unit is a unique combination of the following …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 4, 2024 - 15:34 GMT

  EMEA-002597-PIP05-21-M01

  P/0159/2023 : EMA decision of 12 May 2023 on on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP05-21-M01) Reference Number: EMA/170275/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 4, 2024 - 15:34 GMT

  Recent additions to EMA’s management team

  Georgia Gavriilidou joined EMA on 1 July 2024 as the new Head of the Legal Department, following the retirement of Stefano Marino. She brings over 17 years of in-depth legal and regulatory experience in the EU and the international pharmaceutical landscape …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 4, 2024 - 15:34 GMT

  EMEA-002705-PIP01-19-M01

  P/0164/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M01) Reference Number: EMA/160444/2023

  Distribution channels: Healthcare & Pharmaceuticals Industry