EMEA-000216-PIP01-08 - paediatric investigation plan
dutasteride
tamsulosin hydrochloride
PIPHuman
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Key facts
- Active substance
- dutasteride
- tamsulosin hydrochloride
- Therapeutic area
- Uro-nephrology
- Decision number
- P/42/2008
- PIP number
- EMEA-000216-PIP01-08
- Pharmaceutical form(s)
- Capsule
- Condition(s) / indication(s)
- Treatment of benign prostatic hyperplasia
- Route(s) of administration
- Oral use
- Contact for public enquiries
Merck Sharp & Dohme (Europe) Inc.
Tel.: +1 4388998201
E-mail: axel_breitstadt@merck.com- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- Não