Atectura Breezhaler
indacaterol
mometasone
Asthma
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
EMEA-003122-PIP01-21-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oto-rhino-laryngology
PIP number: P/0020/2023
Route(s) of administration: Nasal use
Pharmaceutical form(s):
Nasal spray suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Mometamax Ultra
gentamicin
posaconazole
mometasone furoate
Last updated:
MedicineVeterinaryAuthorised
Zimbus Breezhaler
indacaterol
glycopyrronium
mometasone furoate
Asthma
Date of authorisation:
Revision: 4
Last updated:
MedicineHumanAuthorised
Bemrist Breezhaler
indacaterol
mometasone
Asthma
Date of authorisation:
Revision: 6
Last updated:
MedicineHumanAuthorised
EMEA-001217-PIP01-11-M08 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0226/2022
Route(s) of administration: Inhalation use
Pharmaceutical form(s):
Inhalation powder
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001812-PIP01-15-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0362/2021
Route(s) of administration: Inhalation use
Pharmaceutical form(s):
Inhalation powder
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002566-PIP01-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: P/0310/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman