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982 results
Medicine
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Opicinumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002194-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tolonium chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002170-PIP01-17, Route(s) of administration: Dental use, Oromucosal use, Pharmaceutical form(s): Oromucosal gel
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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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: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002202-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Netarsudil, Latanoprost
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002175-PIP01-17, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Capmatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002203-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002200-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pilocarpine (hydrochloride), Oxymetazoline hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002181-PIP01-17, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Meldonium dihydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002212-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001397-PIP06-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001397-PIP05-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): benralizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001214-PIP02-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril arginine, amlodipine, Bisoprolol fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002173-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cyramza, Ramucirumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002074-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X