Emend (aprepitant)
- Region
- 🇪🇺 EU
- Active substance
- aprepitant
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Vomiting; Postoperative Nausea and Vomiting; Cancer
- CHMP opinion
- Thu 24 Jul 2003
- EU approval
- Tue 11 Nov 2003
- Application
- EMEA/H/C/000527
- ATC
- A04AD12
- Official record
- www.ema.europa.eu
Indication
Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics). Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years. Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.
Regulatory milestones
Same substance in other markets
- 🇺🇸 Aprepitant Approved · Azurity
- 🇪🇺 Ivemend Authorised · Merck Sharp & Dohme B.V.
- 🇺🇸 Navitrux Approved · Avyxa Holdings
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.