P/117/2010 - paediatric investigation plan
Diclofenac sodium
omeprazole
PIPHuman
Key facts
- Active Substance
- Diclofenac sodium
- omeprazole
- Therapeutic area
- Immunology-Rheumatology-Transplantation
- Decision number
- P/117/2010
- PIP number
- P/117/2010
- Pharmaceutical form(s)
- Modified release capsule
- Condition(s) / indication(s)
- Rheumatoid arthritis
- Ankylosing spondylitis
- Osteoarthritis
- Route(s) of administration
- Oral use
- Contact for public enquiries
Temmler Werke GmbH
E-mail: avril.mankel@ndareg.com
Tel.: +49 8935854000- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date