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53 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
PIP decision type
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
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan Remove RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Dermatology; Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-000347-PIP05-20, Route(s) of administration: Oral use, Intramuscular use, Intravenous use, Pharmaceutical form(s): Oral solution, Orodispersible tablet, Solution for injection, Tablet
Decision date: 17/06/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reparixin
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-001693-PIP02-20, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Tablet, Solution for infusion
Decision date: 07/05/2021, Last updated: 11/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-002472-PIP02-19, Route(s) of administration: Topical use, Pharmaceutical form(s): Gel
Decision date: 08/07/2019, Last updated: 13/11/2019, Compliance check: X