EMEA-000637-PIP02-10-M07
Submitted by Anonymous (not verified) on 19 September 2024 - 13:42
EMEA-000637-PIP02-10-M07
Opinion/decision on a Paediatric investigation plan (PIP): Edurant, Rilpivirine (hydrochloride), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0101/2022
Submitted by Anonymous (not verified) on 19 September 2024 - 13:41
Opinion/decision on a Paediatric investigation plan (PIP): Edurant, Rilpivirine (hydrochloride), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0101/2022
Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0541/2022
Submitted by Anonymous (not verified) on 19 September 2024 - 13:40
Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0541/2022
Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0479/2021
Submitted by Anonymous (not verified) on 19 September 2024 - 13:38
Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0479/2021
Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Opht
Submitted by Anonymous (not verified) on 19 September 2024 - 13:37
Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Ophthalmology, PIP number: P/0066/2022
Opinion/decision on a Paediatric investigation plan (PIP): Onglyza, Saxagliptin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0478/2022
Submitted by Anonymous (not verified) on 19 September 2024 - 13:36
Opinion/decision on a Paediatric investigation plan (PIP): Onglyza, Saxagliptin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0478/2022
Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0270/2022
Submitted by Anonymous (not verified) on 19 September 2024 - 13:32
Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0270/2022
Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Ophthalmology, PIP number: P/0019/2022
Submitted by Anonymous (not verified) on 19 September 2024 - 13:30
Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Ophthalmology, PIP number: P/0019/2022
Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir,abacavir,lamivudine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0038/2023
Submitted by Anonymous (not verified) on 19 September 2024 - 13:30
Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir,abacavir,lamivudine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0038/2023
Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus, Nirsevimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0296/2021
Submitted by Anonymous (not verified) on 19 September 2024 - 13:28
Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus, Nirsevimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0296/2021