For help on how to get the results you want, see our search tips.
36 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002155-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Human Neutrophil Elastase Inhibitor (CHF6333)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002196-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant, Palonosetron
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Other
PIP number: EMEA-001198-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 21/12/2016, Last updated: 31/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 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-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Terguride (hydrogenmaleate)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002015-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Levomilnacipran
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-001724-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release capsule, Capsule, hard
Decision date: 05/06/2015, Last updated: 02/09/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl)phenoxy]butanoic acid
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001573-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/09/2014, Last updated: 14/11/2014, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Acotiamide
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001461-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 05/09/2013, Last updated: 08/10/2013, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Esketamine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP01-13, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, Solution
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tivantinib
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: EMEA-001284-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 24/07/2012, Last updated: 22/08/2012, 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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001066-PIP01-10, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor, recombinant human albumin fusion protein
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: P/36/2011, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/01/2011, Last updated: 24/02/2011, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 4-Hydroxy-n-(2-hydroxyethyl)-butyramide
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000764-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 23/11/2010, Last updated: 20/12/2010, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): sodium sulfate, potassium sulfate, magnesium sulfate heptahydrate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: P/116/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen, alder pollen, hazel pollen
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder and hazel pollen, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection (multidose vial)
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection (multidose vial)
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: Chloroprocaine hydrochloride, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rubidium (82Rb)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Diagnostic
PIP number: EMEA-000488-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Radionuclide generator
Decision date: 18/05/2009, Last updated: 09/07/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dirucotide acetate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-000433-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/03/2009, Last updated: 18/05/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Ophthalmology
PIP number: Dexamethasone, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 23/03/2009, Last updated: 18/05/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Circadin, melatonin
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: Melatonin (Circadin), Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 24/03/2009, Last updated: 18/05/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: Perflubutane, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Lyophilisate for suspension for injection
Decision date: 28/11/2008, Last updated: 29/01/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002344-PIP01-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): moxonidine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002275-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/07/2018, Last updated: 28/11/2018, Compliance check: X