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58 results
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012 -
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Withdrawn application: Pioglitazone ratio
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Pioglitazone ratiopharm GmbH
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Pioglitazone ratiopharm
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Desloratadine Krka
desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011 -
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011 -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011 -
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Withdrawn application: Repaglinide Sun
repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010 -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010 -
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019 -
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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000727-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001410-PIP02-17-M02, Route(s) of administration: Intravenous use, Oral use, Gastric use, Pharmaceutical form(s): Powder for solution for injection, Capsule, hard
Decision date: 16/07/2019, Last updated: 14/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001304-PIP02-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet, Tablet, Age-appropriate oral solid dosage form
Decision date: 12/06/2019, Last updated: 08/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 16/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex-vivo expanded human autologous epithelium containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M02, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 07/12/2018, Last updated: 18/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 19/12/2018, Last updated: 18/02/2019, Compliance check: X