26 February 2013 EMA/124076/2013 Patient Health Protection Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for codeine containing medicinal products used for pain in children Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1342 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E -mail
[email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Member Marketing Product name INN Strength Pharmaceutical Route of State in EEA authorisaton holder form administration Austria Mundipharma GmbH, Codidol retard 60 mg - Dihydrocodeine 60 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria Mundipharma GmbH, Codidol retard 90 mg - Dihydrocodeine 90 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria Mundipharma GmbH, Codidol retard 120 mg - Dihydrocodeine 120 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria G.L. Pharma GmbH, Dehace retard 60 mg - Dihydrocodeine 60 mg prolonged- oral use Schloßplatz 1 Filmtabletten release tablet 8502 Lannach Austria Austria G.L. Pharma GmbH, Dehace retard 90 mg - Dihydrocodeine 90 mg prolonged- oral use Schloßplatz