Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Metoclopramide
Also marketed in the EU under the name(s): Afipran, ANAUSIN METOCLOPRAMIDE, Antiemetin, Cerucal, CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN, CHLORHYDRATE DE METOCLOPRAMIDE RICHARD, CLOPAN, Cloperan, Degan, Dibertil, DICHLORHYDRATE DE METOCLOPRAMIDE PANPHARMA, DIGESTIVO S.PELLEGRINO, ELITAN, Emperal, Gasto-Timelets, Gastronerton, Gastrosil, ISAPRANDIL, Maxolon, MCP 1 A-Pharma, MCP AbZ, MCP AL, MCP axcount, MCP dura, MCP Heumann, MCP Ratiopharm, MCP Sandoz, MCP STADA, MCP-beta, MCP-CT, MCP-ratiopharm, Metoclo-hameln, Metoclopramid, METOCLOPRAMID, Metoclopramid Accord, METOCLOPRAMID ARENA, Metoclopramid AWD, METOCLOPRAMID BIOFARM, METOCLOPRAMID LAROPHARM, Metoclopramid Polpharma, METOCLOPRAMIDA KERN PHARMA, METOCLOPRAMIDA ACCORD, Metoclopramida Labesfal, Metoclopramida Medinfar, METOCLOPRAMIDA PENSA, Metoclopramide, Metoclopramide Accord, METOCLOPRAMIDE CLORIDRATO HOSPIRA, Metoclopramide EG, Metoclopramide HCl 10 PCH, Metoclopramide HCl CF, Metoclopramide Hydrochloride, Metoclopramide Injection BP, METOCLOPRAMIDE MYLAN, METOCLOPRAMIDE SANDOZ, Metoclopramide Tablets BP, Metoclopramidemonohydrochloride Accord, Metoclopramidum Polpharma, Metogastron, N-METOCLOPRAMID, Paspertin, PLASIL, Pramidin, Primperan, PROKINYL L.P., RANDUM, Reglan
Active substance: Metoclopramide
Indication: The authorised indications for products are different but can broadly be grouped in the following way:
•  Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV)
•  Post-operative nausea and vomiting (PONV)
•  Nausea and vomiting associated with migraine
•  Nausea and vomiting of other origins
•  Gastrointestinal motility disorders including gastroparesis
•  Gastroesophageal reflux disease (GORD) and dyspepsia
•  Adjuvant to surgical and radiological procedures
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/01/2014 Referral EMEA/H/A-31/1321 (2013)9846 of 20/12/2013