RENITEC 20 enalapril maleate 20 mg tablet blister pack, Organon Pharma Pty Ltd, CON-783
Product name
RENITEC 20 enalapril maleate 20 mg tablet blister pack
Sponsor name
Organon Pharma Pty Ltd
Consent start
Consent no.
CON-783
Standard
Paragraph 8(1)(i), subsection 9(2), paragraph 9(3)(a) and subsection 9(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform to the requirements of paragraph 8(1)(i), subsection
9(2), paragraph 9(3)(a) and subsection 9(5) of Therapeutic Goods Order No. 91 -
Standard for labels of prescription and related medicines in that Trade name is
disrupted by additional text such as the active ingredient strength.The name of
the medicine and active ingredient do not appear as a cohesive unit on separate
lines and are not immediately below the name of the medicine.The text height of
the active ingredient and strength is not 3 mm or greater.Name and contact
details in respect of a sponsor or distributor has not been updated.
Conditions imposed
The cartons exempted from TGO 91 are identical to those approved by the
Therapeutic Goods Administration.
This exemption only applies to the products specified in the request.
Therapeutic product type
Prescription medicines