For help on how to get the results you want, see our search tips.
823 results
PIP decision type
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Entinostat Polymorph B
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002272-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001151-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002302-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Venglustat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001716-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): T-cell bispecific antibody targeting carcinoembryonic antigen expressed on tumor cells and CD3 epsilon chain present on T-cells
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002252-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pemafibrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001573-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002257-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Humanized recombinant IgG4 anti-human tau antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002226-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate and solvent for concentrate for solution for infusion
Decision date: 15/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Niraparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin, Saxagliptin, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002249-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil sodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002254-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002248-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veliparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000499-PIP04-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form, Tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002239-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/02/2018, Last updated: 18/04/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tucatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002242-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human epidermal growth factor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002258-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fluorocholine (18F)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic
PIP number: EMEA-002129-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002224-PIP01-17, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Sirolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002213-PIP01-17, Route(s) of administration: Implantation, Pharmaceutical form(s): Implant
Decision date: 19/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Resminostat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002211-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002207-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soluble human T cell receptor (TCR) directed against the glycoprotein 100 (gp100) melanoma antigen, linked to the single-chain variable fragment (ScFv) domain of the anti-cluster of differentiation 3 (CD3) antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002197-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vonapanitase
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002195-PIP01-17, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Irrigation solution
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X