Hepatitis B Vaccine
Form: Recombinant injectable vaccine (IM injection), Pre-filled syringes
Strength: 10 µg/0.5 mL
Reference Brands: Engerix-B(US)
Category: Vaccines
Hepatitis B vaccines are approved in both the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality per GMP standards. In the US, FDA regulates these vaccines, requiring clinical trial data and safety profiles. In the EU, CE marking certifies conformity with in vitro diagnostic regulations. These vaccines undergo validation, stability assessments, and extensive audits, with comprehensive documentation including safety profiles, clinical efficacy data, and manufacturing details. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective hepatitis B immunization products worldwide, vital for disease prevention and public health.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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