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Pharmeuropa 33.3 just released

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05 July 2021
Strasbourg, France

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.3 is 30 September 2021.

Users and interested parties are welcome to comment on these drafts. It should be noted that:

  • although draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;
  • if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.

It is therefore extremely important that users provide feedback on such drafts.

Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.

So don’t miss this opportunity to provide your comments. The 47 drafts published in Pharmeuropa 33.3 are listed here.

 

 

Drafts published in Pharmeuropa 33.3 (end of commenting period: 30 September 2021)

Group

1

2.6.16. Tests for extraneous agents in viral vaccines for human use

Reference number: PA/PH/Exp. 15/T (18) 59 ANP

Text number: 20616

Direct link

15

2

2.6.40. Monocyte-activation test for vaccines containing inherently pyrogenic components

Reference number: PA/PH/Exp. 15/T (18) 12 ANP

Text number: 20640

Direct link

15

3

2.8.2. Foreign matter

Reference number: PA/PH/Exp. 13B/T (20) 34 ANP

Text number: 20802

Direct link

13B

4

5.2.2. Chicken flocks free from specified pathogens for the production and quality control of vaccines

Reference number: PA/PH/Exp. 15V/T (21) 10 ANP

Text number: 50202

Direct link

15V

5

5.21. Chemometric methods applied to analytical data

Reference number: PA/PH/Exp. SDA/T (19) 1 ANP

Text number: 52100

Direct link

SDA

6

Amylmetacresol

Reference number: PA/PH/Exp. 10A/T (21) 57 ANP

Text number: 2405

Direct link

10A

7

Benzydamine hydrochloride

Reference number: PA/PH/Exp. 10A/T (19) 133 ANP

Text number: 2759

Direct link

10A

8

Berberis aristata stem

Reference number: PA/PH/Exp. 13B/T (16) 48 ANP

Text number: 2851

Direct link

13B

9

Calcium acetate

Reference number: PA/PH/Exp. 9/T (21) 17 ANP

Text number: 2128

Direct link

9

10

Calcium ascorbate dihydrate

Reference number: PA/PH/Exp. VIT/T (17) 26 ANP

Text number: 1182

Direct link

VIT

11

Cholecalciferol

Reference number: PA/PH/Exp. VIT/T (19) 61 ANP

Text number: 0072

Direct link

VIT

12

Clodronate disodium tetrahydrate

Reference number: PA/PH/Exp. 11/T (21) 26 ANP

Text number: 1777

Direct link

11

13

Crocus for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (21) 19 ANP

Text number: 1624

Direct link

HOM

14

Dabigatran etexilate mesilate

Reference number: PA/PH/Exp. P4/T (19) 17 ANP

Text number: 3095

Direct link

P4

15

Diclazuril for veterinary use

Reference number: PA/PH/Exp. 10B/T (21) 35 ANP

Text number: 1718

Direct link

10B

16

Disodium edetate

Reference number: PA/PH/Exp. SIT/T (20) 35 ANP

Text number: 0232

Direct link

10D

17

Erlotinib hydrochloride

Reference number: PA/PH/Exp. 10C/T (20) 3 ANP

Text number: 3094

Direct link

10C

18

Estriol

Reference number: PA/PH/Exp. 10B/T (21) 59 ANP

Text number: 1203

Direct link

10B

19

Etanercept

Reference number: PA/PH/Exp. MAB/T (21) 11 ANP

Text number: 2895

Direct link

MAB

20

Fructose

Reference number: PA/PH/Exp. CRB/T (21) 18 ANP

Text number: 0188

Direct link

CRB

21

Fulvestrant injection

Reference number: PA/PH/Exp. 10B/T (20) 106 ANP

Text number: 3096

Direct link

10B

22

Golimumab concentrated solution

Reference number: PA/PH/Exp. P4Bio/T (20) 2 ANP

Text number: 3103

Direct link

P4Bio

23

Heparin calcium

Reference number: PA/PH/Exp. 6/T (21) 20 ANP

Text number: 0332

Direct link

6

24

Heparin sodium

Reference number: PA/PH/Exp. 6/T (21) 19 ANP

Text number: 0333

Direct link

6

25

Heparins, low-molecular-mass

Reference number: PA/PH/Exp. 6/T (21) 8 ANP

Text number: 0828

Direct link

6

26

Histamine dihydrochloride

Reference number: PA/PH/Exp. 11/T (21) 27 ANP

Text number: 0143

Direct link

11

27

Influenza vaccine (live, nasal)

Reference number: PA/PH/Exp. 15/T (21) 21 ANP

Text number: 2772

Direct link

15

28

Isoniazid

Reference number: PA/PH/Exp. 10A/T (21) 8 ANP

Text number: 0146

Direct link

10A

29

Lercanidipine hydrochloride

Reference number: PA/PH/Exp. 10B/T (21) 30 ANP

Text number: 3052

Direct link

10B

30

Levocetirizine dihydrochloride

Reference number: PA/PH/Exp. 10C/T (20) 51 ANP

Text number: 3115

Direct link

10C

31

Moxonidine

Reference number: PA/PH/Exp. 10C/T (21) 16 ANP

Text number: 1758

Direct link

10C

32

Ondansetron hydrochloride dihydrate

Reference number: PA/PH/Exp. 10C/T (21) 17 ANP

Text number: 2016

Direct link

10C

33

Palonosetron hydrochloride

Reference number: PA/PH/Exp. 10C/T (19) 52 ANP

Text number: 3041

Direct link

10C

34

Pemetrexed disodium heptahydrate

Reference number: PA/PH/Exp. 10D/T (21) 13 ANP

Text number: 2637

Direct link

10D

35

Propylthiouracil

Reference number: PA/PH/Exp. 11/T (21) 28 ANP

Text number: 0525

Direct link

11

36

Pulsatilla root

Reference number: PA/PH/Exp. TCM/T (20) 35 ANP

Text number: 2972

Direct link

TCM

37

Rabies vaccine (inactivated) for veterinary use

Reference number: PA/PH/Exp. 15V/T (21) 7 ANP

Text number: 0451

Direct link

15V

38

Raltegravir potassium

Reference number: PA/PH/Exp. P4/T (21) 18 ANP

Text number: 2887

Direct link

P4

39

Raltegravir potassium chewable tablets

Reference number: PA/PH/Exp. P4/T (21) 20 ANP

Text number: 2939

Direct link

P4

40

Raltegravir potassium tablets

Reference number: PA/PH/Exp. P4/T (21) 19 ANP

Text number: 2938

Direct link

P4

41

RRR-α-Tocopheryl acetate

Reference number: PA/PH/Exp. VIT/T (20) 12 ANP

Text number: 1257

Direct link

VIT

42

Saposhnikovia root

Reference number: PA/PH/Exp. TCM/T (10) 95 ANP

Text number: 2728

Direct link

TCM

43

Starch, hydroxypropyl

Reference number: PA/PH/Exp. EXP/T (21) 9 ANP

Text number: 2165

Direct link

CRB

44

Starch, hydroxypropyl, pregelatinised

Reference number: PA/PH/Exp. EXP/T (21) 10 ANP

Text number: 2645

Direct link

CRB

45

Thiamine nitrate

Reference number: PA/PH/Exp. VIT/T (21) 23 ANP

Text number: 0531

Direct link

VIT

46

Tibolone

Reference number: PA/PH/Exp. 10B/T (21) 38 ANP

Text number: 1739

Direct link

10B

47

Yellow fever vaccine (live)

Reference number: PA/PH/Exp. 15/T (21) 22 ANP

Text number: 0537

Direct link

15

 

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