Reference Product:
Name of the product: Fluimucil 600
Name of the company: Zambon Spa
Patent expiry date: N/A
Dossier:
Language: English
Format: EU CTD
Registration:
Status: Evaluation on-going
Country: Portugal
Active substance:
Name: Acetylcysteine
Manufacturer: Moehs
DMF: Available
Finished product:
Strength, pharmaceutical form: 1200 mg, effervescent breakable tablets
Manufacturer: France
Industrial batch size: 100.000 tablets (can be raised to 300.000)
Packaging Option 1: Strips made of polyester/aluminium/polyethylene, containing 4 tablets.
Packaging, Option 2: Aluminium tube containing 10 tablets
Secondary packaging details: Box containing 3 strips
Name | Description |
---|---|
Pharma licensing | In-licensing (demand) |