The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Dropizol 10 mg/ml Oral Drops Solution

10 milligram(s)/millilitre Oral drops, solution

Pharmanovia A/SPA2245/001/001

Main Information

Trade NameDropizol 10 mg/ml Oral Drops Solution
Active SubstancesOPIUM TINCTURE
Strength10 milligram(s)/millilitre
Dosage FormOral drops, solution
Licence HolderPharmanovia A/S
Licence NumberPA2245/001/001

Group Information

ATC CodeA07DA Antipropulsives
A07DA02 opium

Status

Authorised/WithdrawnAuthorised
Licence Issued22/06/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back