N-acetylcysteine 1200 mg effervescent tablets

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

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