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31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, PM: decision on the application for modification of an agreed PIP, P/0306/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), PM: decision on the application for modification of an agreed PIP, P/0285/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, PM: decision on the application for modification of an agreed PIP, P/0243/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), PM: decision on the application for modification of an agreed PIP, P/0260/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), PM: decision on the application for modification of an agreed PIP, P/0286/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0310/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Vamorolone, PM: decision on the application for modification of an agreed PIP, P/0288/2018
31/01/2019 Regulatory and procedural guideline: Electronic product information for human medicines in the European Union – draft key principles
31/01/2019 News and press releases: Public consultation on key principles for the electronic product information of EU medicines
31/01/2019 Electronic product information for human medicines in the European Union – draft key principles
31/01/2019 Product-information requirements
31/01/2019 European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI) , European Medicines Agency, London, UK, from 28/11/2018 to 28/11/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olipudase alfa, PM: decision on the application for modification of an agreed PIP, P/0258/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0253/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0301/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, PM: decision on the application for modification of an agreed PIP, P/0146/2019
30/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Osilodrostat, PM: decision on the application for modification of an agreed PIP, P/0252/2018
30/01/2019 Scientific guideline: Procedure on management of proposals submitted by Interested Parties for European Union List Entries or European Union herbal monographs - Revision 2
30/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Trobalt, retigabine, W: decision granting a waiver in all age groups for all conditions/indications, P/0299/2018