CFDA: Conversion of 21 drugs to non-***

Food and Drug Administrations of provinces, autonomous regions, and municipalities directly under the Central Government:

According to the “Administrative Measures for the Classification of Prescription Drugs and Non-prescription Drugs (Trial)” (Order No. 10 of the State Drug Administration Order), 21 drugs (5 kinds of chemical medicines and 16 kinds of proprietary Chinese medicines) such as Chaihuang Capsules are organized and approved by the General Administration of Administration. ) Convert to non-prescription drugs. The list of the 21 drugs to be converted and their specifications for non-prescription drugs (see annex) will be published. Please inform the relevant drug manufacturers in the administrative region to do the following:

1. Before October 30th, 2014, the supplementary application for revision of the specification was submitted for filing according to the "Registration Measures for Drug Registration" and other relevant regulations. The other contents of the manual should be consistent with the original approval. The medicines produced since the date of filing the supplementary filing shall not continue to use the original medicine instructions. Except for the double-span varieties managed by prescription drugs and non-prescription drugs, respectively.

Second, the contents of the revised manual should be promptly notified to the relevant medical institutions, drug management companies and other units.

Third, if the drug label involves relevant contents, it shall be revised together.

annex:

List of 21 drugs that are converted to non-prescription drugs

No.

Drug Name

Specifications (components)

category

Note

1

Chai Huang Capsule

0.5g per pack

Class B

2

Dehumidifying itching ointment

(1) 10 grams per pack; (2) 20 grams per pack

Class B

3

Compound Banlangen oral solution

10 ml per pack

Class B

Double span

4

Compound Corydalis Spray

(1) 10 ml per bottle; (2) 20 ml per bottle

Class A

5

Guipi Capsule

0.3 grams per pack

Class B

Double span

6

Flower hundred capsules

0.4g per tablet

Class A

7

Jianpi cake

Each tablet weighs 0.8 grams

Class A

8

White sheet

Each tablet weighs 0.4 grams

Class A

9

Gold anti-itch granules

(1) 8 grams per bag; (2) 6 grams per bag (without sucrose)

Class A

10

Jin Gu Tong Xiao Wan

6 grams per bag

Class A

11

Liu Wei Neng Xiao Tablet

Each tablet weighs 0.5 grams

Class A

Double span

12

Qingfei suppression capsule

0.5g per pack

Class A

13

Qing Huo Yang Yuan Tablets

Each tablet weighs 0.5 grams

Class A

14

Pomegranate

250 ml per bottle

Class A

15

Yi Qing

Each tablet weighs 0.5 grams

Class A

Double span

16

Yizhongshengxue

Each tablet weighs 0.3 grams (film coating)

Class A

17

Ibuprofen sustained-release capsules

0.4g

Class A

Double span

18

Famotidine calcium magnesium chewable tablets

Each tablet contains famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg

Class A

19

Clotrimazole Vaginal Effervescent Tablets

0.5g

Class A

20

Amorolfine hydrochloride liniment

5%

Class A

twenty one

Acetylcysteine ​​tablets

0.2g

Class A



Tags: CFDA Drugs Non-prescription Drugs