Study title:
Product-Ibuprofen Pediatric 03.88-05.90 Memos, Correspondence, IND memos, AMA Press release (03.21.95), Confidential Inv. Brochure chewable Tablet, Protocol Review (P/2750/0003, P/3100/0162, P/2000/0430), NDA 19-833, NDA 19-842, NDA-833, Arthritis and Rheumatism Journals (01.89)
Type of medicine: Medicines containing chemical active substances
|
Therapeutic area: Anesthesia and Analgesia [E03]
|
Brands: Please see report |
MAH holders: Please see report, Please see report, Please see report, Please see report |
Assessment: |
Active substance: IBUPROFEN |
ATC code: |
Document link:
|
Document date:
|
Study number: |
EudraCT number:
|
Scope of study: Clinical |
Population of study subjects:
|
Preterm newborn Infants
|
Newborn infants
(1 to 27 days)
|
Infants and toddlers
(28 days to 24 months)
|
Children
(2 to 11 years)
|
Adolescents
(12 to 18 years)
|
|
-
|
-
|
-
|
Y
|
-
|