For help on how to get the results you want, see our search tips.
55 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
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Live bacterium B. thetaiotaomicron
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Gastroentology-Hepatology
PIP number: Live bacterium B. thetaiotaomicron, Route(s) of administration: Oral use, Pharmaceutical form(s): Live Bacteria in an Enteric Coated Capsule
Decision date: 21/08/2009, Last updated: 22/10/2009, 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): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, 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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): trandolapril
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-002274-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/07/2018, Last updated: 28/11/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134)
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-002469-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Ophthalmology
PIP number: EMEA-002423-PIP01-18, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Ophthalmic insert
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide 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: Psychiatry
PIP number: EMEA-002519-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 14/06/2019, Last updated: 07/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP03-18, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 25/07/2019, Last updated: 12/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertactin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Infectious diseases
PIP number: EMEA-002343-PIP01-18, Route(s) of administration: Intramuscular use,
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone (sodium phosphate), levofloxacin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-002375-PIP02-18, Route(s) of administration: Auricular use, Pharmaceutical form(s): Ear drops, solution
Decision date: 17/07/2019, Last updated: 13/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): brimonidine
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Ophthalmology
PIP number: EMEA-002558-PIP01-19, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): eflornithine (hydrochloride monohydrate), sulindac
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oncology
PIP number: EMEA-001518-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 06/12/2019, Last updated: 30/03/2020, 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: EMEA-000639-PIP04-19, Route(s) of administration: Epidural use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 04/06/2020, 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: EMEA-000639-PIP05-19, Route(s) of administration: Ocular use, Pharmaceutical form(s): Gel
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human IgGlA monoclonal Fab antibody
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-002766-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 15/07/2020, Last updated: 16/06/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oncology
PIP number: EMEA-002247-PIP02-17, Route(s) of administration: Oral use, Naso-gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
List item
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 -
List item
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