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MyoblocMyobloc / NeuroBloc (rimabotulinumtoxinB)

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Myobloc is a Botulinum toxin type A product (Drug), registered by ELAN PHARM. Linked registrations: US BLA103846, UK PLGB 50702/0001. First approved in US on 2000-12-08 (BLA103846). Data as of 2026-11-09.

  • Regulatory classBotulinum toxin type A · Drug
  • HolderELAN PHARM
  • JurisdictionsUS · UK
  • Updated2026-11-09 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Myobloc

Product
Regulatory class
Drug
Category
Botulinum toxin type A
US · FDA BLA
BLA103846
UK · MHRA marketing authorisation
PLGB 50702/0001
Name on registration
MYOBLOC
Registrant
ELAN PHARM
First approval
2000-12-08
Models and sizes
MYOBLOC （Botulinum Toxin Type B 5000IU/VIAL） VIAL [Prescription] #001
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.Registrant and dates are from BLA103846; 2 registrations linked.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    BLA103846 first approved

  2. US

    BLA103846 · BLA103846/S5120

    补充申请 S5120 批准｜Labeling｜FDA 文件：Label、Letter

  3. US

    BLA103846 · BLA103846/S5156

    补充申请 S5156 批准｜Labeling｜FDA 文件：Letter

  4. US

    BLA103846 · BLA103846/S5190

    补充申请 S5190 批准｜Efficacy｜FDA 文件：Letter、Label、Medication Guide

  5. US

    BLA103846 · BLA103846/S5195

    补充申请 S5195 批准｜Labeling｜FDA 文件：Label、Medication Guide、Letter

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

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Recent changes

4
  • BLA103846: 补充申请 S5195 批准｜Labeling｜FDA 文件：Label、Medication Guide、Letter2021-03-10
  • BLA103846: 补充申请 S5190 批准｜Efficacy｜FDA 文件：Letter、Label、Medication Guide2019-08-20
  • BLA103846: 补充申请 S5156 批准｜Labeling｜FDA 文件：Letter2012-06-13
  • BLA103846: 补充申请 S5120 批准｜Labeling｜FDA 文件：Label、Letter2009-07-31

Sources

2