Revocation of Consent to the Distribution of Medicines
Pursuant to section 35(1) of the Medicines Act 1981, the Minister of Health hereby revokes the consent to the distribution of the medicines in New Zealand granted under section 20 of the Act for the following medicines:
| Product: | Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant |
| Active Ingredients: | Phenylephrine hydrochloride 0.667mg/mL Pholcodine 1mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Difflam Plus Cough Sore Throat Lozenges (Sugar Free Honey, Lemon & Ginger Flavour) |
| Active Ingredients: | Pholcodine 5.5mg Benzydamine hydrochloride 1.5mg Cetylpyridinium chloride 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Difflam Plus Cough Sore Throat Lozenges (Sugar Free Pineapple & Lime Flavour) |
| Active Ingredients: | Pholcodine 5.5mg Benzydamine hydrochloride 1.5mg Cetylpyridinium chloride 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Strong Pholcodine Linctus BP |
| Active Ingredient: | Pholcodine 2mg/mL |
| Dosage Form: | Linctus |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Pinewood Laboratories Limited, Clonmel, Ireland |
| Product: | Duro-Tuss Dry Cough Liquid Forte |
| Active Ingredient: | Pholcodine 3mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Duro-Tuss Dry Cough (Orange) |
| Active Ingredients: | Pholcodine 5.5mg Cetylpyridinium chloride monohydrate 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Duro-Tuss Dry Cough Liquid Junior (New Formula) |
| Active Ingredient: | Pholcodine 1mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Duro-Tuss Cough Liquid Expectorant |
| Active Ingredients: | Bromhexine hydrochloride 0.8mg/mL Pholcodine 1mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Duro-Tuss Dry Cough Liquid Regular (New Formula) |
| Active Ingredient: | Pholcodine 1mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Pholcodine Linctus BP |
| Active Ingredient: | Pholcodine 1mg/mL |
| Dosage Form: | Linctus |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Pinewood Laboratories Limited, Clonmel, Ireland |
| Product: | Difflam Plus Dry Cough + Antibacterial + Anti-inflammatory (Blackcurrant Flavour Sugar Free) |
| Active Ingredients: | Benzydamine hydrochloride 1.5mg Pholcodine 5.5mg Cetylpyridinium chloride monohydrate 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Duro-Tuss Dry Cough (Lemon) |
| Active Ingredients: | Pholcodine 5.5mg Cetylpyridinium chloride monohydrate 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Stubborn Dry Tickly Cough (Pharmacy Health) |
| Active Ingredient: | Pholcodine 2mg/mL |
| Dosage Form: | Linctus |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand |
Dated this 22nd day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).