For help on how to get the results you want, see our search tips.
22 results
-
List item
Summary of opinion: Vildagliptin / Metformin hydrochloride Accord
vildagliptin / metformin hydrochloride, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
List item
Summary of opinion: Dimethyl fumarate Polpharma
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Dimethyl fumarate Neuraxpharm
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Dimethyl fumarate Mylan
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Amifampridine SERB
amifampridine, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Pirfenidone AET
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Zokinvy (new)
lonafarnib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Upstaza (new)
eladocagene exuparvovec, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Ertapenem SUN (new)
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Sugammadex Fresenius Kabi (new)
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Sitagliptin / Metformin hydrochloride Accord (new)
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Ganirelix Gedeon Richter (new)
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 21/07/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X